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1.  Adolescents demonstrate improvement in obesity risk behaviors following completion of Choice, Control, and Change, a curriculum addressing personal agency and autonomous motivation 
The rapid increase of obesity and diabetes risk beginning in youth, particularly those from disadvantaged communities, calls for prevention efforts.
To examine the impact of a curriculum intervention, Choice, Control, and Change (C3), on the adoption of the energy balance related behaviors of decreasing sweetened drinks, packaged snacks, fast food, and leisure screen time, and increasing water, fruits and vegetables, and physical activity, and on potential psychosocial mediators of the behaviors.
Ten middle schools in low-income New York City neighborhoods were randomly assigned within matched pairs to either intervention or comparison/ delayed control conditions during the 2007–2008 school year.
562 inner city seventh grade students in the intervention condition, and 574 in the comparison condition.
Students received the 24 C3 lessons that used science inquiry-based investigations to enhance motivation for action, and social cognitive and self-determination theories to increase personal agency and autonomous motivation to take action.
Main outcome measures
Self-report instruments to measure energy balance related behaviors targeted by the curriculum, and potential psychosocial mediators of the behaviors.
ANCOVA with group (intervention/control) as a fixed factor and pre-test as covariate.
Students in intervention schools compared to the delayed intervention controls reported consumption of significantly fewer sweetened drinks and packaged snacks, smaller sizes of fast food, increased intentional walking for exercise, and decreased leisure screen-time, but showed no increases in their intakes of water, fruits, and vegetables. They showed significant increases in positive outcome expectations about the behaviors, self-efficacy, goal intentions, competence, and autonomy.
The C3 curriculum was effective in improving many of the specifically targeted behaviors related to reducing obesity risk, indicating that combining inquiry-based science education and behavioral theory is a promising approach.
PMCID: PMC3016947  PMID: 21111093
2.  Mediators of the effect of the JUMP-in intervention on physical activity and sedentary behavior in Dutch primary schoolchildren from disadvantaged neighborhoods 
Important health benefits can be achieved when physical activity in children from low socio-economic status is promoted and sedentariness is limited. By specifying the mediating mechanisms of existing interventions one can improve future physical activity interventions. This study explored potential mediators of the long-term effect of the school-based multicomponent JUMP-in intervention on sport participation, outdoor play and screen time in Dutch primary schoolchildren from disadvantaged neighborhoods.
In total, 600 primary schoolchildren (aged 9.8 ± 0.7, 51% girls, 13% Dutch ethnicity, 35% overweight) from 9 intervention and 10 control schools were included in the analyses. JUMP-in was developed using Intervention Mapping, and targeted psychological and environmental determinants of physical activity. Outcome behaviors were self-reported sport participation, outdoor play, TV-viewing behavior and computer use. Potential mediators were self-reported psychological, social and physical environmental factors.
JUMP-in was effective in improving sport participation after 20 months, but not in improving outdoor play, or reducing TV-viewing or computer time. JUMP-in was not effective in changing hypothesized mediators so no significant mediated effects could be identified. However, changes in self-efficacy, social support and habit strength were positively associated with changes in sport participation, and changes in social support, self-efficacy, perceived planning skills, enjoyment and habit strength were positively associated with changes in outdoor play. Changes in enjoyment was positively associated with changes in TV-viewing while parental rules were negatively associated. Having a computer in the bedroom and enjoyment were positively associated with changes in computer use, while changes in parental rules were negatively associated.
Besides a significant positive effect on sports participation, no significant intervention effect on outdoor play, screen time or any of the potential mediators was found. This suggest that other (unmeasured) factors operated as mediating mechanisms of the intervention, that we used unsuccessful intervention strategies, that the strategies were inappropriately implemented, or that children are unable to accurately recall past activities and cognitions. Additionally, the school setting might not be the sole channel to influence leisure time activities. Still, several personal and environmental constructs were found to be relevant in predicting change in sport participation, outdoor play and screen behavior and seem to be potential mediators. Future interventions are recommended including more effective strategies targeting these relevant constructs, addressing different constructs (e.g. pedagogic skills of parents), and focusing on different implementation settings.
Trail registration
PMCID: PMC3541111  PMID: 23130806
Mediating; Working mechanisms; Youth; Intervention; Physical activity; Sport; Sedentary; Sitting; Television
3.  Prevention of relapsing backache 
The condition of non-specific back pain is characterized by high prevalence, non satisfactory therapeutic options and severe socioeconomic consequences. Therefore prevention seems an attractive option to downsize the problem. However, the construction of effective preventive measures is complicated by the obscure aetiology of the condition, the multidimensionality of risk and prognostic factors (bio psychosocial model!) and the variability of its natural as well as clinical course. This led to the development of a wide variety of preventive measures: e. g. exercise programs, educational measures (including back school), ergonomic modification of the work environment, mechanical supports (e. g. back belts) as well as multidisciplinary interventions. For two reasons the workplace seems to be a suitable setting for prevention. First, because a number of strong risk factors are associated with working conditions and second, because it allows addressing a large proportion of the adult population. Against this background the assessment at hand sets out to answer the following questions:
What is the amount and methodological quality of the available scientific literature on the effectiveness of back pain prevention in the workplace environment? What are effective measures for the prevention of back pain and its consequences in the workplace environment and how effective are they? Is back pain prevention in the workplace environment cost-effective? Is there a need for more research? As primary outcomes for effectiveness the assessment will focus on time lost from work and the frequency and duration of episodes with back pain. The preventive measures assessed belong to the following categories: exercise programs, educational and information measures, multidimensional interventions, back belts, lifting teams and ergonomic interventions.
The assessment is based on a systematic review of the published literature according to the methodological requirements of DAHTA. Proceedings of the electronic literature searches are documented in the appendix. In addition references of review articles were searched. Methodological quality of publications (systematic reviews, HTA reports) was assessed using the checklists developed by the German Scientific Working Group for Technology Assessment in Health Care (GSWGTAHC) or with the Jadad-Score (controlled trials) respectively. Due to the large number of relevant publications the assessment is mainly based on data reported by systematic reviews and supplemented by the results of newer trials. A separate economic assessment was not performed because of the low amount of available data. An assessment of ethical, legal and social impact was omitted due to resource constraints.
For preventive interventions based on exercise programs most of the analysed trials demonstrate some effectiveness. Due to the heterogeneity of the programs it is not possible to conclude whether positive effects are associated with a special type, duration or intensity of exercise. For purely educational measures or information strategies applied in a workplace setting the available trials were not able to demonstrate effectiveness. Back school programs, which in addition to theoretical instructions offer intensive exercising may in the short term, be successful in reducing the incidence of new episodes of back pain. Some trials in high risk groups demonstrate effectiveness of multidimensional interventions on time lost from work. These programs include education and exercise as well as cognitive behavioural interventions to change pain perception. The assessment of the benefits of back belts for the prevention of back pain is based on results of high quality efficacy as well as effectiveness trials. Their results imply for the otherwise healthy working population no protective effect of back belts on time lost from work due to back pain, on the incidence of painful episodes or on days with impairment by back pain. So far there are no data from controlled trials that demonstrate the effectiveness of "lifting teams" in nursing care to prevent back pain or its consequences. However, results from uncontrolled pilot studies indicate a potential for effectiveness. Among "ergonomic interventions" three different approaches have to be distinguished: interventions addressing changes of the workplace setting, interventions addressing the individual's behaviour and combined interventions. Studies evaluating the effectiveness of setting interventions (modification of the physical workplace environment, changes of production processes, organisational changes) yield no dependable results. This conclusion is not based on indifferent trial results but rather on the lack of methodologically sound studies. Results from studies on ergonomic interventions addressing the individual confirm the conclusions drawn for exercise and educational measures. The most marked results are found in trials that examine the effectiveness of combined interventions in high risk groups and contain a strong participatory component. Hardly any of the trials studying the effects of ergonomic interventions satisfied methodological quality criteria that are accepted standard for clinical or public health intervention studies.
There were no data allowing firm conclusions on the cost-effectiveness of interventions from any of the categories.
The significance of the results of the assessment at hand is strongly limited by the comprehensiveness of the questions addressed. Reviewing the literature on the basis of (even systematic) review articles impairs the differentiated examination of the role of target groups, program contents, application and duration, effect sizes and context factors. While the methodological quality of the review articles is quite high, the quality of individual trials (even those included in the review papers) is highly variable. While most trials examining preventive interventions addressed at individuals satisfy at least some methodological requirements many studies dealing with setting interventions do not.
In conclusion, sound scientific evidence for the effectiveness and cost-effectiveness of back pain prevention in the workplace environment is still quite scarce. Further research should include:
The development of interventions guided by the bio psychosocial model of back pain aetiology that combines individual prevention as well as measures addressing the workplace environment.The integration of results from basic ergonomic research into prevention concepts and the conduct of trials focussing outcomes with relevance to the workplace setting. The conduct of qualitative studies to identify factors that impair the effectiveness of prevention programs (e. g. motivation, compliance, people skills).The integration of cost-effectiveness evaluations into all interventional studies.
PMCID: PMC3011361  PMID: 21289963
4.  An Intervention to Reduce HIV Risk Behavior of Substance-Using Men Who Have Sex with Men: A Two-Group Randomized Trial with a Nonrandomized Third Group 
PLoS Medicine  2010;7(8):e1000329.
In a randomized trial of a behavioral intervention among substance-using men who have sex with men, aimed at reducing sexual risk behavior, Mansergh and colleagues fail to find evidence of a reduction in risk from the intervention.
Substance use during sex is associated with sexual risk behavior among men who have sex with men (MSM), and MSM continue to be the group at highest risk for incident HIV in the United States. The objective of this study is to test the efficacy of a group-based, cognitive-behavioral intervention to reduce risk behavior of substance-using MSM, compared to a randomized attention-control group and a nonrandomized standard HIV-testing group.
Methods and Findings
Participants (n = 1,686) were enrolled in Chicago, Los Angeles, New York City, and San Francisco and randomized to a cognitive-behavioral intervention or attention-control comparison. The nonrandomized group received standard HIV counseling and testing. Intervention group participants received six 2-h group sessions focused on reducing substance use and sexual risk behavior. Attention-control group participants received six 2-h group sessions of videos and discussion of MSM community issues unrelated to substance use, sexual risk, and HIV/AIDS. All three groups received HIV counseling and testing at baseline. The sample reported high-risk behavior during the past 3 mo prior to their baseline visit: 67% reported unprotected anal sex, and 77% reported substance use during their most recent anal sex encounter with a nonprimary partner. The three groups significantly (p<0.05) reduced risk behavior (e.g., unprotected anal sex reduced by 32% at 12-mo follow-up), but were not different (p>0.05) from each other at 3-, 6-, and 12-mo follow-up. Outcomes for the 2-arm comparisons were not significantly different at 12-mo follow-up (e.g., unprotected anal sex, odds ratio = 1.14, confidence interval = 0.86–1.51), nor at earlier time points. Similar results were found for each outcome variable in both 2- and 3-arm comparisons.
These results for reducing sexual risk behavior of substance-using MSM are consistent with results of intervention trials for other populations, which collectively suggest critical challenges for the field of HIV behavioral interventions. Several mechanisms may contribute to statistically indistinguishable reductions in risk outcomes by trial group. More explicit debate is needed in the behavioral intervention field about appropriate scientific designs and methods. As HIV prevention increasingly competes for behavior-change attention alongside other “chronic” diseases and mental health issues, new approaches may better resonate with at-risk groups.
Trial Registration NCT00153361
Please see later in the article for the Editors' Summary
Editors' Summary
AIDS first emerged in the early 1980s among gay men living in the US. As the disease spread around the world, it became clear that AIDS also affects heterosexual men and women. Now, three decades on, more than 30 million people are infected with HIV, the virus that causes AIDS. HIV is most often spread by having unprotected sex with an infected partner and, globally, most sexual transmission of HIV now occurs during heterosexual sex. However, 5%–10% of all new HIV infections still occur in men who have sex with men (MSM, a term that encompasses gay, bisexual, transgendered, and heterosexual men who sometimes have sex with men) and, in several high-income countries, male-to-male sexual contact remains the most important HIV transmission route. In the US, for example, more than half of the approximately 50,000 people who become infected with HIV every year do so through male-to-male sexual contact.
Why Was This Study Done?
In countries where MSM are the group at highest risk of HIV infection, any intervention that reduces HIV transmission in MSM should have a major effect on the overall HIV infection rate. Among MSM, sexual behaviors that increase the risk of HIV infection (for example, not using a condom, having anal sex, having sex with a partner of unknown HIV status, and having sex with many partners) are associated with the use of alcohol and noninjection drugs (for example, inhaled amyl nitrite or poppers) during or shortly before sexual encounters. In this study (Project MIX), the researchers investigate whether a group-based behavioral intervention reduces sexual risk behavior in substance-using MSM.
What Did the Researchers Do and Find?
The researchers recruited substance-using MSM from four US cities who had had risky sex at least once in the past 6 months. Participants were randomized to a cognitive-behavioral intervention or to an attention-control group; a third, nonrandomized group of MSM formed a standard HIV counseling and testing only group. All the groups had HIV counseling and testing at the start of the study and completed a questionnaire about their substance use and sexual risk behavior during their most recent anal sex encounter. The cognitive-behavior group then received six weekly 2-hour group sessions focused on reducing substance use and sexual risk behavior by helping the men change their thinking (cognition) and behavior regarding sexual risk taking. The attention-control group received six group sessions about general MSM issues such as relationships, excluding discussion of substance use, and sexual risk behavior. The participants in both of these groups completed the questionnaire about their substance use and sexual risk behavior again at 3, 6, and 12 months after the group sessions; the participants in the standard HIV counseling and testing group completed the questionnaire again about 5 months after completing the first questionnaire (to control for the time taken by the other two groups to complete the intervention). At baseline, about 67% of the participants reported unprotected anal sex and 77% reported substance use during their most recent anal sex encounter with a nonprimary partner. At the 3-month follow-up, the incidence of sexual risk behavior had fallen to about 43% in all three groups; the incidence of substance use during sex had fallen to about 50%. Risk taking and substance use remained at these levels in the intervention and attention-control groups at the later follow-up time points.
What Do These Findings Mean?
These findings suggest that this cognitive-behavioral intervention is no better at reducing sexual risk taking among substance-using MSM than is an unrelated video-discussion group or standard HIV counseling and testing. One explanation for this negative result might be that brief counseling is especially effective with people who are ready for a change such as MSM willing to enroll in an intervention trial of this type. Alternatively, just being in the trial might have encouraged all the participants to self-report reduced risk behavior. Thus, alternative scientific designs and methods might be needed to find behavioral interventions that can effectively reduce HIV transmission among substance-using MSM and other people at high risk of HIV infection. Importantly, however, these findings raise the question of whether more extensive, multilevel interventions or broader lifestyle and positive health approaches (rather than single-level or single-subject behavioral interventions) might be needed to reduce sexual risk behavior among substance-using MSM.
Additional Information
Please access these Web sites via the online version of this summary at
Information is available from the US Department of Health and Human Services on HIV prevention programs, research, and policy
Information is available from the US National Institute of Allergy and Infectious Diseases on HIV infection and AIDS
HIV InSite has comprehensive information on all aspects of HIV/AIDS, including information on HIV transmission and transmission in gay men and other MSM, on substance abuse and HIV/AIDS, and on safer sex
Information is available from Avert, an international AIDS nonprofit, on all aspects of HIV/AIDS, including information on HIV, AIDS, and men who have sex with men and on drink, drugs, and sex (in English and Spanish)
The US Centers for Disease Control and Prevention also have information for the public and for professionals about HIV/AIDS among men who have sex with men (in English and Spanish)
The US National Institute on Drug Abuse has information on HIV/AIDS and drug abuse, including a resource aimed at educating teenagers about the link between drug abuse and the spread of HIV in the US (in English and Spanish)
PMCID: PMC2927550  PMID: 20811491
5.  Comparison of Two Theory-Based, Fully Automated Telephone Interventions Designed to Maintain Dietary Change in Healthy Adults: Study Protocol of a Three-Arm Randomized Controlled Trial 
JMIR Research Protocols  2014;3(4):e62.
Health behavior change interventions have focused on obtaining short-term intervention effects; few studies have evaluated mid-term and long-term outcomes, and even fewer have evaluated interventions that are designed to maintain and enhance initial intervention effects. Moreover, behavior theory has not been developed for maintenance or applied to maintenance intervention design to the degree that it has for behavior change initiation.
The objective of this paper is to describe a study that compared two theory-based interventions (social cognitive theory [SCT] vs goal systems theory [GST]) designed to maintain previously achieved improvements in fruit and vegetable (F&V) consumption.
The interventions used tailored, interactive conversations delivered by a fully automated telephony system (Telephone-Linked Care [TLC]) over a 6-month period. TLC maintenance intervention based on SCT used a skills-based approach to build self-efficacy. It assessed confidence in and barriers to eating F&V, provided feedback on how to overcome barriers, plan ahead, and set goals. The TLC maintenance intervention based on GST used a cognitive-based approach. Conversations trained participants in goal management to help them integrate their newly acquired dietary behavior into their hierarchical system of goals. Content included goal facilitation, conflict, shielding, and redundancy, and reflection on personal goals and priorities. To evaluate and compare the two approaches, a sample of adults whose F&V consumption was below public health goal levels were recruited from a large urban area to participate in a fully automated telephony intervention (TLC-EAT) for 3-6 months. Participants who increase their daily intake of F&V by ≥1 serving/day will be eligible for the three-arm randomized controlled trial. A sample of 405 participants will be randomized to one of three arms: (1) an assessment-only control, (2) TLC-SCT, and (3) TLC-GST. The maintenance interventions are 6 months. All 405 participants who qualify for the trial will complete surveys administered by blinded interviewers at baseline (randomization), 6, 12, 18, and 24 months.
Data analysis is not yet complete, but we hypothesize that (1) TLC-GST > TLC-SCT > control at all follow-up time points for F&V consumption, and (2) intervention effects will be mediated by the theoretical constructs (eg, self-efficacy, goal pursuit, conflict, shielding, and facilitation).
This study used a novel study design to initiate and then promote the maintenance of dietary behavior change through the use of an evidence-based fully automated telephony intervention. After the first 6 months (the acquisition phase), we will examine whether two telephony interventions built using different underlying behavioral theories were more successful than an assessment-only control group in helping participants maintain their newly acquired health behavior change.
Trial Registration NCT00148525; (Archived by Webcite at
PMCID: PMC4260007  PMID: 25387065
maintenance; social cognitive theory; goals; fruit; vegetable; diet; telephone; health information systems
6.  Social support from teachers mediates physical activity behavior change in children participating in the Fit-4-Fun intervention 
Few studies have examined the mediators of behavior change in successful school-based physical activity interventions. The aim of this study was to explore potential mediators of physical activity in the Fit-4-Fun program for primary school children.
Group randomized controlled trial.
Four primary schools were recruited in April, 2011 and randomized by school into intervention or control conditions. Participants included 213 children (mean age = 10.7 years ± 0.6; 52.2% female) with the treatment group (n = 118) completing the 8-week multi-component Fit-4-Fun program. Participants were assessed at baseline, 3- and 6-months. Physical activity was measured using Yamax SW700 pedometers (mean steps/day) and questionnaires were used to assess constructs from Social Cognitive Theory and Competence Motivation Theory. Hypothesized mediators measured included social support from peers, parents and teachers; physical activity self-efficacy (barrier and task); enjoyment; and perceived school physical environment. Mediation was assessed using Preacher and Hayes’ multiple mediation regression SPSS macro. Action theory (A), conceptual theory (B) and the significance of the product of coefficients (AB) are reported.
The intervention had a significant effect on physical activity (p<0.001). The action theory test results revealed significant treatment effects at 3-months for perceived school environment (A=0.28, p<0.001); and at 6-month follow-up for perceived school environment (A=0.058, p<0.001), teacher social support (A=0.54, p<0.05) and enjoyment (A=-0.23, p<0.05). The conceptual theory test revealed a significant relationship between changes in teacher social support and changes in physical activity at 6-month follow-up (B=828, P<0.05). Teacher social support was shown to have a significant mediating effect on physical activity (AB = 445, CI = 77-1068 steps, proportion= 13%), and perceived school environment approached significance (AB = 434, CI= -415 to 1507 steps, proportion= 13%).
The Fit-4-Fun program successfully targeted social support for physical activity provided by classroom teachers which contributed to improved physical activity in children. These results demonstrate that classroom teachers play a key role in influencing physical activity behavior outcomes in children.
Trial Registration No: ACTRN12611000976987
PMCID: PMC3672071  PMID: 23714651
Mediators; Physical activity; Children; School intervention; Health-related fitness
7.  Processes of behavior change and weight loss in a theory-based weight loss intervention program: a test of the process model for lifestyle behavior change 
Process evaluation is important for improving theories of behavior change and behavioral intervention methods. The present study reports on the process outcomes of a pilot test of the theoretical model (the Process Model for Lifestyle Behavior Change; PMLBC) underpinning an evidence-informed, theory-driven, group-based intervention designed to promote healthy eating and physical activity for people with high cardiovascular risk.
108 people at high risk of diabetes or heart disease were randomized to a group-based weight management intervention targeting diet and physical activity plus usual care, or to usual care. The intervention comprised nine group based sessions designed to promote motivation, social support, self-regulation and understanding of the behavior change process. Weight loss, diet, physical activity and theoretically defined mediators of change were measured pre-intervention, and after four and 12 months.
The intervention resulted in significant improvements in fiber intake (M between-group difference = 5.7 g/day, p < .001) but not fat consumption (−2.3 g/day, p = 0.13), that were predictive of weight loss at both four months (M between-group difference = −1.98 kg, p < .01; R2 = 0.2, p < 0.005), and 12 months (M difference = −1.85 kg, p = 0.1; R2 = 0.1, p < 0.01). The intervention was successful in improving the majority of specified mediators of behavior change, and the predicted mechanisms of change specified in the PMBLC were largely supported. Improvements in self-efficacy and understanding of the behavior change process were associated with engagement in coping planning and self-monitoring activities, and successful dietary change at four and 12 months. While participants reported improvements in motivational and social support variables, there was no effect of these, or of the intervention overall, on physical activity.
The data broadly support the theoretical model for supporting some dietary changes, but not for physical activity. Systematic intervention design allowed us to identify where improvements to the intervention may be implemented to promote change in all proposed mediators. More work is needed to explore effective mechanisms within interventions to promote physical activity behavior.
Electronic supplementary material
The online version of this article (doi:10.1186/s12966-014-0160-6) contains supplementary material, which is available to authorized users.
PMCID: PMC4304200  PMID: 25592314
Physical activity; Diet; Weight loss intervention; Process evaluation
8.  Impact of a physical activity intervention program on cognitive predictors of behaviour among adults at risk of Type 2 diabetes (ProActive randomised controlled trial) 
In the ProActive Trial an intensive theory-based intervention program was no more effective than theory-based brief advice in increasing objectively measured physical activity among adults at risk of Type 2 diabetes. We aimed to illuminate these findings by assessing whether the intervention program changed cognitions about increasing activity, defined by the Theory of Planned Behaviour, in ways consistent with the theory.
N = 365 sedentary participants aged 30–50 years with a parental history of Type 2 diabetes were randomised to brief advice alone or to brief advice plus the intervention program delivered face-to-face or by telephone. Questionnaires at baseline, 6 and 12 months assessed cognitions about becoming more physically active. Analysis of covariance was used to test intervention impact. Bootstrapping was used to test multiple mediation of intervention impact.
At 6 months, combined intervention groups (face-to-face and telephone) reported that they found increasing activity more enjoyable (affective attitude, d = .25), and they perceived more instrumental benefits (e.g., improving health) (d = .23) and more control (d = .32) over increasing activity than participants receiving brief advice alone. Stronger intentions (d = .50) in the intervention groups than the brief advice group at 6 months were partially explained by affective attitude and perceived control. At 12 months, intervention groups perceived more positive instrumental (d = .21) and affective benefits (d = .29) than brief advice participants. The intervention did not change perceived social pressure to increase activity.
Lack of effect of the intervention program on physical activity over and above brief advice was consistent with limited and mostly small short-term effects on cognitions. Targeting affective benefits (e.g., enjoyment, social interaction) and addressing barriers to physical activity may strengthen intentions, but stronger intentions did not result in more behaviour change. More powerful interventions which induce large changes in TPB cognitions may be needed. Other interventions deserving further evaluation include theory-based brief advice, intensive measurement of physical and psychological factors, and monitoring of physical activity. Future research should consider a wider range of mediators of physical activity change, assess participants' use of self-regulatory strategies taught in the intervention, and conduct experimental studies or statistical modelling prior to trial evaluation. ISRCTN61323766.
PMCID: PMC2669044  PMID: 19292926
9.  Better exercise adherence after treatment for cancer (BEAT Cancer) study: Rationale, design, and methods 
Contemporary Clinical Trials  2011;33(1):124-137.
Most breast cancer survivors do not engage in regular physical activity. Our physical activity behavior change intervention for breast cancer survivors significantly improved physical activity and health outcomes post-intervention during a pilot, feasibility study. Testing in additional sites with a larger sample and longer follow-up is warranted to confirm program effectiveness short and longer term. Importantly, the pilot intervention resulted in changes in physical activity and social cognitive theory constructs, enhancing our potential for testing mechanisms mediating physical activity behavior change. Here, we report the rationale, design, and methods for a two-site, randomized controlled trial comparing the effects of the BEAT Cancer physical activity behavior change intervention to usual care on short and longer term physical activity adherence among breast cancer survivors. Secondary aims include examining social cognitive theory mechanisms of physical activity behavior change and health benefits of the intervention. Study recruitment goal is 256 breast cancer survivors with a history of ductal carcinoma in situ or Stage I, II, or IIIA disease who have completed primary cancer treatment. Outcome measures are obtained at baseline, 3 months (i.e., immediately post-intervention), 6 months, and 12 months and include physical activity, psychosocial factors, fatigue, sleep quality, lower extremity joint dysfunction, cardiorespiratory fitness, muscle strength, and waist-to-hip ratio. Confirming behavior change effectiveness, health effects, and underlying mechanisms of physical activity behavior change interventions will facilitate translation to community settings for improving the health and well-being of breast cancer survivors.
PMCID: PMC3253876  PMID: 21983625
oncology; exercise; survivorship; predictors; adherence
Using a multivariate extension of the Baron and Kenny (1986) mediation framework, we examined the simultaneous effect of psychosocial variables hypothesized to mediate the relationship between a motivationally-tailored physical activity intervention, and 6-month physical activity behavior in 239 healthy, under-active adults (mean age=47.5; 82% women). Participants were randomly assigned to 1) Print-based feedback; 2) Telephone-based feedback; or 3) Contact Control. All mediation criteria were satisfied for both intervention arms. In terms of effect size, a moderate indirect effect of Print (0.39, 95% CI=0.21, 0.57) was due to increases in behavioral processes (0.54, 95% CI= 0.29, 0.80) being attenuated by decreases due to cognitive processes (-0.17, 95%CI= -0.31,-.03). A moderate indirect effect was observed for Telephone (0.47, 95% CI=0.28, 0.66), with increases due to behavioral processes (0.61, 95% CI=0.34, 0.87) attenuated by decreases due to cognitive processes (0.15, 95% CI=-0.27, -0.02); self-efficacy and decisional balance mediational paths did not attain statistical significance. These findings highlight the importance of studies that deconstruct the theoretical components of interventions to determine which combination produces the greatest behavior changes at the lowest cost.
PMCID: PMC2692944  PMID: 18642998
Mediators; Physical Activity; Intervention studies; Randomized controlled trial; Multivariate analysis
11.  The Faith, Activity, and Nutrition Program 
American journal of preventive medicine  2013;44(2):10.1016/j.amepre.2012.09.062.
Faith-based interventions hold promise for promoting health in ethnic minority populations. To date, however, few of these interventions have used a community-based participatory research (CBPR) approach, have targeted both physical activity and healthy eating, and have focused on structural changes in the church.
To report the results of a group randomized CBPR intervention targeting physical activity and healthy eating in African-American churches.
Group RCT. Data were collected from 2007 to 2011. Statistical analyses were conducted in 2012.
Seventy-four African Methodist Episcopal (AME) churches in South Carolina and 1257 members within them participated in the study.
Churches were randomized to an immediate (intervention) or delayed (control) 15-month intervention that targeted organizational and environmental changes consistent with the structural ecologic model. A CBPR approach guided intervention development. Intervention churches attended a full-day committee training and a full-day cook training. They also received a stipend and 15 months of mailings and technical assistance calls to support intervention implementation.
Main outcome measures
Primary outcomes were self-reported moderate-to-vigorous-intensity physical activity (MVPA), self-reported fruit and vegetable consumption, and measured blood pressure. Secondary outcomes were self-reported fat- and fiber-related behaviors. Measurements were taken at baseline and 15 months. Intent-to-treat repeated measures ANOVA tested group X time interactions, controlling for church clustering, wave, and size, and participant age, gender, and education. Post hoc ANCOVAs were conducted with measurement completers.
There was a significant effect favoring the intervention group in self-reported leisure-time MVPA (d=0.18, p=0.02), but no effect for other outcomes. ANCOVA analyses showed an intervention effect for self-reported leisure-time MVPA (d=0.17, p=0.03) and self-reported fruit and vegetable consumption (d=0.17, p=0.03). Trainings were evaluated very positively (training evaluation item means of 4.2–4.8 on a 5-point scale).
This faith-based structural intervention using a CBPR framework showed small but significant increases in self-reported leisure-time MVPA. This program has potential for broad-based dissemination and reach.
Trial registration
This study is registered at NCT00379925.
PMCID: PMC3884828  PMID: 23332327
12.  Moms in motion: a group-mediated cognitive-behavioral physical activity intervention 
When examining the prevalence of physical inactivity by gender and age, women over the age of 25 are at an increased risk for sedentary behavior. Childbearing and motherhood have been explored as one possible explanation for this increased risk. Post natal exercise studies to date demonstrate promising physical and psychological outcomes, however few physical activity interventions have been theory-driven and tailored to post natal exercise initiates. The purpose of this study was to compare the effects of a group-mediated cognitive behavioral intervention based upon social-cognitive theory and group dynamics (GMCB) to a standard care postnatal exercise program (SE).
A randomized, two-arm intervention design was used. Fifty-seven post natal women were randomized to one of two conditions: (1) a standard exercise treatment (SE) and (2) a standard exercise treatment plus group-mediated cognitive behavioral intervention (GMCB). Participants in both conditions participated in a four-week intensive phase where participants received standard exercise training. In addition, GMCB participants received self-regulatory behavioral skills training via six group-mediated counseling sessions. Following the intensive phase, participants engaged in a four-week home-based phase of self-structured exercise. Measures of physical activity, barrier efficacy, and proximal outcome expectations were administered and data were analyzed using ANCOVA procedures.
Results and discussion
ANCOVA of change scores for frequency, minutes, and volume of physical activity revealed significant treatment effects over the intensive and home-based phases (p's < 0.01). In addition, ANCOVA of change in mean barrier efficacy and proximal outcome expectations at the conclusion of the intensive phase demonstrated that GMCB participants increased their initial level of barrier efficacy and outcome expectations while SE participants decreased (p < 0.05).
While both exercise programs resulted in improvements to exercise participation, the GMCB intervention produced greater improvement in overall physical activity, barrier efficacy and proximal outcome expectations.
PMCID: PMC1564034  PMID: 16925809
13.  Exploring mediators of accelerometer assessed physical activity in young adolescents in the HEalth In Adolescents study – a group randomized controlled trial 
BMC Public Health  2012;12:814.
There is a shortage of information about the factors that mediate physical activity intervention effects which involve youth. The purpose of this study was to examine whether personal, social and physical-environmental factors mediated the intervention effect on physical activity and whether gender and weight status moderated mediated effects in the Health In Adolescents Study – a school-based intervention to promote healthy weight development among young adolescents.
Participating schools were randomized to Control (n = 25) and Intervention (n = 12). The intervention components to enhance physical activity targeted change through theoretically informed mediators embedded in a social-ecological framework. Accelerometer assessed physical activity (mean count per minute) and self-efficacy, enjoyment, perceived social support from parents, teachers and friends and perceived environmental opportunities were measured by questionnaires at baseline and post-intervention after 20 months among 700 11–13 year-old adolescents (Intervention = 485; Control = 215). The product-of-coefficient test was used to examine mediation.
No mediating effect of any of the hypothesized mediators was identified and gender and weight status did not moderate any mediated effects with the exception of weight status that moderated the mediated effect of enjoyment. Few intervention effects were seen on the mediators, except for a positive change in social support from teachers among girls and the normal weight, and a negative effect on enjoyment and self-efficacy among the overweight. However, change in enjoyment, self-efficacy, perceived social support from friends and environmental opportunities were associated with change in mean count per minute with some variation across the investigated subgroups, and thus show evidence of being potential mediators of physical activity change in adolescents.
While no mediation effects were observed, change in both personal and social-environmental factors predicted change in physical activity behavior. Hence, a social- ecological approach targeting a wide range of determinants to promote change in physical activity holds promise. Overweight and normal weight adolescents may not respond in the same way to school-based physical activity interventions. Therefore, strategies to better reach the overweight seem needed. Future studies should continue to identify mediating and moderation mechanisms in physical activity change in adolescents.
PMCID: PMC3532838  PMID: 22995043
Mediation; Adolescents; Accelerometer; Physical activity; Intervention
14.  Reduced Barriers Mediated Physical Activity Maintenance Among Breast Cancer Survivors 
To better understand mechanisms of physical activity (PA) behavior change in breast cancer survivors, we examined mediation of a successful PA behavior change intervention by social cognitive theory (SCT) constructs. Our exploratory study randomized 41 breast cancer survivors to receive the 3-month intervention (INT) or usual care (UC). We used the Freedman and Schatzkin approach to examine mediation of intervention effect on PA 3 months postintervention by changes in SCT constructs from baseline to immediately postintervention. Compared with UC, the INT group reported lower barriers interference (mean difference = −7.8, 95% CI [−15.1, −0.4], d = −0.67, p = .04) and greater PA enjoyment (mean difference = 0.7, 95% CI [0, 1.5], d = 0.61, p = .06). Barriers interference mediated 39% (p = .004) of the intervention effect on PA 3 months postintervention. PA enjoyment was not a significant mediator. Reducing barriers to PA partially explained our intervention effect.
PMCID: PMC3145412  PMID: 21558582
oncology; exercise; social cognitive theory; predictor; breast cancer; survivorship
15.  A cluster-randomised, controlled trial to assess the impact of a workplace osteoporosis prevention intervention on the dietary and physical activity behaviours of working women: study protocol 
BMC Public Health  2013;13:405.
Osteoporosis is a debilitating disease and its risk can be reduced through adequate calcium consumption and physical activity. This protocol paper describes a workplace-based intervention targeting behaviour change in premenopausal women working in sedentary occupations.
A cluster-randomised design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the clusters and units of randomisation and intervention. Sample size calculations incorporated the cluster design. Final number of clusters was determined to be 16, based on a cluster size of 20 and calcium intake parameters (effect size 250 mg, ICC 0.5 and standard deviation 290 mg) as it required the highest number of clusters.
Sixteen workplaces were recruited from a pool of 97 workplaces and randomly assigned to intervention and control arms (eight in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organisation wide educational activities. Workplaces in the control/standard care arm received print resources. Intervention workshops were guided by self-efficacy theory and included participatory activities such as goal setting, problem solving, local food sampling, exercise trials, group discussion and behaviour feedback.
Outcomes measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, four weeks and six months post intervention.
This study addresses the current lack of evidence for behaviour change interventions focussing on osteoporosis prevention. It addresses missed opportunities of using workplaces as a platform to target high-risk individuals with sedentary occupations. The intervention was designed to modify behaviour levels to bring about risk reduction. It is the first to address dietary and physical activity components each with unique intervention strategies in the context of osteoporosis prevention. The intervention used locally relevant behavioural strategies previously shown to support good outcomes in other countries. The combination of these elements have not been incorporated in similar studies in the past, supporting the study hypothesis that the intervention will be more efficacious than standard practice in osteoporosis prevention through improvements in calcium intake and physical activity.
PMCID: PMC3654951  PMID: 23627684
Osteoporosis prevention; Cluster randomised trial; Premenopausal women; Workplace; Calcium intake; Physical activity
16.  Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial – study protocol 
Diabetes and obesity have reached epidemic proportions in the U.S. with rates consistently higher among Hispanics as compared to non-Hispanic whites. Among Hispanic women diagnosed with gestational diabetes mellitus (GDM), 50% will go on to develop type 2 diabetes within 5 years of the index pregnancy. Although randomised controlled trials among adults with impaired glucose tolerance have shown that diet and physical activity reduce the risk of type 2 diabetes, such programs have not been tested in high-risk postpartum women. The overall goal of this randomised controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce risk factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a history of abnormal glucose tolerance during pregnancy.
Hispanic pregnant women who screen positive for GDM will be recruited and randomly assigned to a Lifestyle Intervention (n = 150) or a Health & Wellness (control) Intervention (n = 150). Multimodal contacts (i.e., in-person, telephone, and mailed materials) will be used to deliver the intervention from late pregnancy (29 weeks gestation) to 12 months postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for postpartum weight loss; American Congress of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and addresses the specific cultural and environmental challenges faced by low-income Hispanic women. Assessments will be conducted at enrollment, and at 6-weeks, 6-months, and 12-months postpartum by trained bicultural and bilingual personnel blinded to the intervention arm. Efficacy will be assessed via postpartum weight loss and biomarkers of insulin resistance and cardiovascular risk. Changes in physical activity and diet will be measured via 7-day actigraph data and three unannounced 24-hour dietary recalls at each assessment time period.
Hispanic women are the fastest growing minority group in the U.S. and have the highest rates of sedentary behavior and postpartum diabetes after a diagnosis of GDM. This randomised trial uses a high-reach, low-cost strategy that can readily be translated into clinical practice in underserved and minority populations.
Trial registration
PMCID: PMC3975296  PMID: 24606590
Lifestyle intervention; Randomised controlled trial; Healthy eating; Prevention; Diet; Latina; Physical activity; Postpartum; Pregnancy; Gestational diabetes mellitus; Transtheoretical model
17.  A socio-ecological approach promoting physical activity and limiting sedentary behavior in adolescence showed weight benefits maintained 2.5 years after intervention cessation 
Obesity in youth remains a major public health issue. Yet no effective long-term preventive strategy exists. We previously showed that a school-based socio-ecological approach targeting behavior and social/environmental influences on physical activity (PA) prevented 4-year excessive weight gain in 12-year olds. In this study, we investigated if this efficacy persists 30 months after intervention cessation.
Methods and Findings:
The program targeted students, family, school and the living environment to promote/support PA and prevent sedentary behavior (SB). A total of 732 students from eight randomized middle schools completed the 4-year trial. At the 30-month post-trial follow-up, body mass index (BMI), fat mass index (FMI), leisure PA (LPA), home/school/workplace active commuting, TV/video time (TVT), and attitudes toward PA were measured in 531 adolescents. The beneficial effects of the intervention on the excess BMI increase (+0.01 vs +0.34 kg m−2 in the intervention and control groups, respectively) and on the overweight incidence in initially non-overweight students (4.3% vs 8.6% odds ratio=0.48 (95% confidence interval: 0.23–1.01)) were maintained at the post-trial follow-up. LPA was not maintained at the level achieved during the trial. However, we still observed a prevention of the age-related decrease of the adolescents' percentage reporting regular LPA (−14.4% vs −26.5%) and a higher intention to exercise in the intervention group. The intervention promoted lower TVT (−14.0 vs +13.6 min per day) and higher active commuting changes (+11.7% vs −4.8%). Trends in higher BMI reduction in students with high initial TVT and in the least wealthy group were noted. TVT changes throughout the follow-up predicted excess BMI and FMI changes.
Long-term multilevel approach targeting PA and SB prevents excessive weight gain up to 30 months after intervention cessation. The efficacy may be higher in the most sedentary and least wealthy adolescents. Healthy PA-related behavior inducing long-lasting weight effects can be promoted in youth providing that an ecological approach is introduced in the prevention strategy.
PMCID: PMC4088336  PMID: 24509504
physical activity; sedentary behavior; overweight; cluster randomized study; prevention
18.  A cluster randomised controlled trial of the efficacy of a brief walking intervention delivered in primary care: Study protocol 
BMC Family Practice  2011;12:56.
The aim of the present research is to conduct a fully powered explanatory trial to evaluate the efficacy of a brief self-regulation intervention to increase walking. The intervention will be delivered in primary care by practice nurses (PNs) and Healthcare Assistants (HCAs) to patients for whom increasing physical activity is a particular priority. The intervention has previously demonstrated efficacy with a volunteer population, and subsequently went through an iterative process of refinement in primary care, to maximise acceptability to both providers and recipients.
Methods/ Design
This two arm cluster randomised controlled trial set in UK general practices will compare two strategies for increasing walking, assessed by pedometer, over six months. Patients attending practices randomised to the self-regulation intervention arm will receive an intervention consisting of behaviour change techniques designed to increase walking self-efficacy (confidence in ability to perform the behaviour), and to help people translate their "good" intentions into behaviour change by making plans. Patients attending practices randomised to the information provision arm will receive written materials promoting walking, and a short unstructured discussion about increasing their walking.
The trial will recruit 20 PN/HCAs (10 per arm), who will be trained by the research team to deliver the self-regulation intervention or information provision control intervention, to 400 patients registered at their practices (20 patients per PN/HCA). This will provide 85% power to detect a mean difference of five minutes/day walking between the self-regulation intervention group and the information provision control group. Secondary outcomes include health services costs, and intervention effects in sub-groups defined by age, ethnicity, gender, socio-economic status, and clinical condition. A mediation analysis will investigate the extent to which changes in constructs specified by the Theory of Planned Behaviour lead to changes in objectively assessed walking behaviour.
This trial addresses the current lack of evidence for interventions that are effective at increasing walking and that can be offered to patients in primary care. The intervention being evaluated has demonstrated efficacy, and has been through an extensive process of adaptation to ensure acceptability to both provider and recipient, thus optimising fidelity of intervention delivery and treatment receipt. It therefore provides a strong test of the hypothesis that a self-regulation intervention can help primary care patients increase their walking.
Trial registration
Current Controlled Trials ISRCTN95932902
PMCID: PMC3141510  PMID: 21699717
19.  Prevention of low back pain and its consequences among nurses’ aides in elderly care: a stepped-wedge multi-faceted cluster-randomized controlled trial 
BMC Public Health  2013;13:1088.
A high prevalence of low back pain has persisted over the years despite extensive primary prevention initiatives among nurses’ aides. Many single-faceted interventions addressing just one aspect of low back pain have been carried out at workplaces, but with low success rate. This may be due to the multi-factorial origin of low back pain. Participatory ergonomics, cognitive behavioral training and physical training have previously shown promising effects on prevention and rehabilitation of low back pain. Therefore, the main aim of this study is to examine whether a multi-faceted workplace intervention consisting of participatory ergonomics, physical training and cognitive behavioral training can prevent low back pain and its consequences among nurses’ aides. External resources for the participating workplace and a strong commitment from the management and the organization support the intervention.
To overcome implementation barriers within usual randomized controlled trial designed workplace interventions, this study uses a stepped-wedge cluster-randomized controlled trial design with 4 groups. The intervention is delivered to the groups at random along four successive time periods three months apart. The intervention lasts three months and integrates participatory ergonomics, physical training and cognitive behavioral training tailored to the target group. Local physiotherapists and occupational therapists conduct the intervention after having received standardized training. Primary outcomes are low back pain and its consequences measured monthly by text messages up to three months after initiation of the intervention.
Intervention effectiveness trials for preventing low back pain and its consequences in workplaces with physically demanding work are few, primarily single-faceted, with strict adherence to a traditional randomized controlled trial design that may hamper implementation and compliance, and have mostly been unsuccessful. By using a stepped wedge design, and obtain high management commitment and support we intend to improve implementation and aim to establish the effectiveness of a multi-faceted intervention to prevent low back pain. This study will potentially provide knowledge of prevention of low back pain and its consequences among nurses’ aides. Results are expected to be published in 2015–2016.
Trial registration
The study is registered as ISRCTN78113519.
PMCID: PMC4222590  PMID: 24261985
Participatory ergonomics; Cognitive behavioral training; Physical training; Musculoskeletal disorders; Workplace intervention; Health care workers
20.  Non-Specialist Psychosocial Interventions for Children and Adolescents with Intellectual Disability or Lower-Functioning Autism Spectrum Disorders: A Systematic Review 
PLoS Medicine  2013;10(12):e1001572.
In a systematic review, Brian Reichow and colleagues assess the evidence that non-specialist care providers in community settings can provide effective interventions for children and adolescents with intellectual disabilities or lower-functioning autism spectrum disorders.
Please see later in the article for the Editors' Summary
The development of effective treatments for use by non-specialists is listed among the top research priorities for improving the lives of people with mental illness worldwide. The purpose of this review is to appraise which interventions for children with intellectual disabilities or lower-functioning autism spectrum disorders delivered by non-specialist care providers in community settings produce benefits when compared to either a no-treatment control group or treatment-as-usual comparator.
Methods and Findings
We systematically searched electronic databases through 24 June 2013 to locate prospective controlled studies of psychosocial interventions delivered by non-specialist providers to children with intellectual disabilities or lower-functioning autism spectrum disorders. We screened 234 full papers, of which 34 articles describing 29 studies involving 1,305 participants were included. A majority of the studies included children exclusively with a diagnosis of lower-functioning autism spectrum disorders (15 of 29, 52%). Fifteen of twenty-nine studies (52%) were randomized controlled trials and just under half of all effect sizes (29 of 59, 49%) were greater than 0.50, of which 18 (62%) were statistically significant. For behavior analytic interventions, the best outcomes were shown for development and daily skills; cognitive rehabilitation, training, and support interventions were found to be most effective for improving developmental outcomes, and parent training interventions to be most effective for improving developmental, behavioral, and family outcomes. We also conducted additional subgroup analyses using harvest plots. Limitations include the studies' potential for performance bias and that few were conducted in lower- and middle-income countries.
The findings of this review support the delivery of psychosocial interventions by non-specialist providers to children who have intellectual disabilities or lower-functioning autism spectrum disorders. Given the scarcity of specialists in many low-resource settings, including many lower- and middle-income countries, these findings may provide guidance for scale-up efforts for improving outcomes for children with developmental disorders or lower-functioning autism spectrum disorders.
Protocol Registration
PROSPERO CRD42012002641
Please see later in the article for the Editors' Summary
Editors' Summary
Newborn babies are helpless, but over the first few years of life, they acquire motor (movement) skills, language (communication) skills, cognitive (thinking) skills, and social (interpersonal interaction) skills. Individual aspects of these skills are usually acquired at specific ages, but children with a development disorder such as an autism spectrum disorder (ASD) or intellectual disability (mental retardation) fail to reach these “milestones” because of impaired or delayed brain maturation. Autism, Asperger syndrome, and other ASDs (also called pervasive developmental disorders) affect about 1% of the UK and US populations and are characterized by abnormalities in interactions and communication with other people (reciprocal socio-communicative interactions; for example, some children with autism reject physical affection and fail to develop useful speech) and a restricted, stereotyped, repetitive repertoire of interests (for example, obsessive accumulation of facts about unusual topics). About half of individuals with an ASD also have an intellectual disability—a reduced overall level of intelligence characterized by impairment of the skills that are normally acquired during early life. Such individuals have what is called lower-functioning ASD.
Why Was This Study Done?
Most of the children affected by developmental disorders live in low- and middle-income countries where there are few services available to help them achieve their full potential and where little research has been done to identify the most effective treatments. The development of effective treatments for use by non-specialists (for example, teachers and parents) is necessary to improve the lives of people with mental illnesses worldwide, but particularly in resource-limited settings where psychiatrists, psychologists, and other specialists are scarce. In this systematic review, the researchers investigated which psychosocial interventions for children and adolescents with intellectual disabilities or lower-functioning ASDs delivered by non-specialist providers in community settings produce improvements in development, daily skills, school performance, behavior, or family outcomes when compared to usual care (the control condition). A systematic review identifies all the research on a given topic using predefined criteria; psychosocial interventions are defined as therapy, education, training, or support aimed at improving behavior, overall development, or specific life skills without the use of drugs.
What Did the Researchers Do and Find?
The researchers identified 29 controlled studies (investigations with an intervention group and a control group) that examined the effects of various psychosocial interventions delivered by non-specialist providers to children (under 18 years old) who had a lower-functioning ASD or intellectual disability. The researchers retrieved information on the participants, design and methods, findings, and intervention characteristics for each study, and calculated effect sizes—a measure of the effectiveness of a test intervention relative to a control intervention—for several outcomes for each intervention. Across the studies, three-quarters of the effect size estimates were positive, and nearly half were greater than 0.50; effect sizes of less than 0.2, 0.2–0.5, and greater than 0.5 indicate that an intervention has no, a small, or a medium-to-large effect, respectively. For behavior analytic interventions (which aim to improve socially significant behavior by systematically analyzing behavior), the largest effect sizes were seen for development and daily skills. Cognitive rehabilitation, training, and support (interventions that facilitates the relearning of lost or altered cognitive skills) produced good improvements in developmental outcomes such as standardized IQ tests in children aged 6–11 years old. Finally, parental training interventions (which teach parents how to provide therapy services for their child) had strong effects on developmental, behavioral, and family outcomes.
What Do These Findings Mean?
Because few of the studies included in this systematic review were undertaken in low- and middle-income countries, the review's findings may not be generalizable to children living in resource-limited settings. Moreover, other characteristics of the included studies may limit the accuracy of these findings. Nevertheless, these findings support the delivery of psychosocial interventions by non-specialist providers to children who have intellectual disabilities or a lower-functioning ASD, and indicate which interventions are likely to produce the largest improvements in developmental, behavioral, and family outcomes. Further studies are needed, particularly in low- and middle-income countries, to confirm these findings, but given that specialists are scarce in many resource-limited settings, these findings may help to inform the implementation of programs to improve outcomes for children with intellectual disabilities or lower-functioning ASDs in low- and middle-income countries.
Additional Information
Please access these websites via the online version of this summary at
This study is further discussed in a PLOS Medicine Perspective by Bello-Mojeed and Bakare
The US Centers for Disease Control and Prevention provides information (in English and Spanish) on developmental disabilities, including autism spectrum disorders and intellectual disability
The US National Institute of Mental Health also provides detailed information about autism spectrum disorders, including the publication “A Parent's Guide to Autism Spectrum Disorder”
Autism Speaks, a US non-profit organization, provides information about all aspects of autism spectrum disorders and includes information on the Autism Speaks Global Autism Public Health Initiative
The National Autistic Society, a UK charity, provides information about all aspects of autism spectrum disorders and includes personal stories about living with these conditions
The UK National Health Service Choices website has an interactive guide to child development and information about autism and Asperger syndrome, including personal stories, and about learning disabilities
The UK National Institute for Health and Care Excellence provides clinical guidelines for the management and support of children with autism spectrum disorders
The World Health Organization provides information on its Mental Health Gap Action Programme (mhGAP), which includes recommendations on the management of developmental disorders by non-specialist providers; the mhGAP Evidence Resource Center provides evidence reviews for parent skills training for management of children with intellectual disabilities and pervasive developmental disorders and interventions for management of children with intellectual disabilities
PROSPERO, an international prospective register of systematic reviews, provides more information about this systematic review
PMCID: PMC3866092  PMID: 24358029
21.  A randomised controlled trial among cleaners-Effects on strength, balance and kinesiophobia 
BMC Public Health  2011;11:776.
Cleaners constitute a job group with poor health and low socioeconomic resources. Therefore, there is a great need for scientifically documented health promoting initiatives for cleaners. However, both workplace initiatives and high quality intervention studies are lacking. The aim of this study was to evaluate the effects of a 3-month workplace trial with interventions to improve physical or cognitive behavioural resources among cleaners.
A cluster randomised controlled trial was conducted among 294 female cleaners from 9 workplaces. The participants were allocated to three groups: Physical coordination training (PCT, n = 95), Cognitive behavioural theory-based training (CBTr, n = 99) and Reference group (REF, n = 100). Interventions were conducted during work hours for an average of 1 hour/week. Muscle strength was measured by maximal voluntary contractions in trunk/extension, and shoulder abduction/elevation. Postural balance was measured on a force platform. Kinesiophobia was measured with Tampa Scale for Kinesiophobia. Test and questionnaires were completed at baseline and at 3-month follow-up and analyses followed the intention-to-treat (ITT) principle with last observation carried forward in case of missing data at follow-up. Reports and analyses are given on true observations as well.
ITT-analyses revealed that PCT improved strength of the trunk (p < .05) and postural balance (p < .05) compared to CBTr and REF. Based on true observations the strength and balance improvements corresponded to ~20% and ~16%, respectively. ITT-analyses showed that CBTr reduced kinesiophobia compared to PCT and REF (p < .05). Based on true observations, the improvement corresponded to a ~16% improvement.
This workplace-based intervention study including PCT and CBTr among cleaners improved strength and postural balance from PCT, and kinesiophobia from CBTr. The improved strength, postural balance and kinesiophobia may improve the cleaners' tolerance for high physical work demands. Future studies should investigate the potential in the combination of PCT and CBTr in a workplace intervention.
Trial registration
Current controlled trials ISRCTN96241850
PMCID: PMC3201927  PMID: 21985226
22.  Interventions to Increase Walking Behavior 
Medicine and science in sports and exercise  2008;40(7 Suppl):S567-S573.
Walking is the most prevalent and preferred method of physical activity for both work and leisure purposes, thus making it a prime target for physical activity promotion interventions. We identified 14 randomized controlled trials, which tested interventions specifically targeting and assessing walking behavior. Results show that among self-selected samples intensive interventions can increase walking behavior relative to controls. Brief telephone prompts appear to be as effective as more substantial telephone counseling. Although more research is needed, individual studies support prescriptions to walk 5–7 d/wk versus 3–5 d/wk and at a moderate (versus vigorous) intensity pace, with no differences in total walking minutes when single or multiple daily walking bouts are prescribed. Mediated interventions delivering physical activity promotion materials through non-face-to-face channels may be ideal for delivering walking promotion interventions and have shown efficacy in promoting overall physical activity, especially when theory-based and individually tailored. Mass media campaigns targeting broader audiences, including those who may not intend to increase their physical activity, have been successful at increasing knowledge and awareness about physical activity, but are often too diffuse to successfully impact individual behavior change. Incorporating individually tailored programs into broader mass media campaigns may be an important next step, and the Internet could be a useful vehicle.
PMCID: PMC2694671  PMID: 18562974
Walking; Physical Activity; Exercise; Mediated Interventions; Behavior Change
23.  The effect of mere-measurement of cognitions on physical activity behavior: a randomized controlled trial among overweight and obese individuals 
The promotion of physical activity among an overweight/obese population is an important challenge for clinical practitioners and researchers. In this regard, completing a questionnaire on cognitions could be a simple and easy strategy to increase levels of physical activity. Thus, the aim of the present study was to test the effect of completing a questionnaire based on the Theory of Planned Behavior (TPB) on the level of physical activity.
Overall, 452 overweight/obese adults were recruited and randomized to the experimental or control group. At baseline, participants completed a questionnaire on cognitions regarding their participation in leisure-time physical activity (experimental condition) versus a questionnaire on fruit and vegetable consumption (control condition). The questionnaires assessed the TPB variables that are beliefs, attitude, norm, perception of control, intention and a few additional variables from other theories. At three-month follow-up, leisure-time physical activity was self-reported by means of a short questionnaire. An analysis of covariance with baseline physical activity level as covariate was used to verify the effect of the intervention.
At follow-up, 373 participants completed the leisure-time physical activity questionnaire. The statistical analysis showed that physical activity participation was greater among participants in the experimental condition than those in the control condition (F(1,370) = 6.85, p = .009, d = 0.20).
Findings indicate that completing a TPB questionnaire has a significant positive impact on subsequent participation in physical activity. Consequently, asking individuals to complete such a questionnaire is a simple, inexpensive and easy strategy to increase the level of physical activity among overweight/obese adults.
PMCID: PMC3023726  PMID: 21223565
24.  ‘Changing Minds’: determining the effectiveness and key ingredients of an educational intervention to enhance healthcare professionals’ intentions to prescribe physical activity to patients with physical disabilities 
Healthcare professionals (HCPs) are vital conduits of leisure-time physical activity (LTPA) information; however, few discuss LTPA with their patients with disabilities. ‘Changing Minds, Changing Lives’ (CMCL) is a nationwide, theory- and evidence-based seminar aimed at increasing LTPA-discussion among HCPs by enhancing their attitudes, subjective norms, perceived behavioural control (PBC), and intentions. The purposes of the current study were to: examine the effectiveness and short- and long-term maintenance of a CMCL seminar on HCPs’ social cognitions to discuss LTPA; and explore key implementation variables that predict changes in HCPs’ social cognitions.
Prior-to, as well as immediately, one, and six months following a CMCL seminar, 97 HCPs (Mage ± SD = 36.23 ± 10.42; 69.0% female; 97.9% Caucasian; 38.1% rehabilitation therapists; years in profession = 11.56 ± 9.94) from five Canadian provinces completed questionnaires that assessed the Theory of Planned Behaviour constructs with regard to discussing LTPA with their patients with a physical disability. Key presenter characteristics and intervention delivery components were extracted from presenter demographic questionnaires and seminar checklists, respectively. Separate repeated-measures ANOVAs and post-hoc t-tests evaluated changes in HCPs’ social cognitions. Hierarchical multiple regressions were conducted to predict intentions and to understand which implementation variables may help explain significant changes in social cognitions.
Significant increases in HCPs’ social cognitions for discussing LTPA were reported from pre- to post-seminar (ps <0.002); however, increases were not maintained at follow-up. PBC emerged as the strongest predictor of participants’ post-CMCL intentions (β = 0.45, p <0.001). Although several implementation characteristics were related to changes in perceptions, the number of seminars the presenter delivered was the only significant negative predictor of post-seminar PBC (β = -0.18, p <0.05).
Future iterations of the CMCL intervention should include additional strategies to sustain improvements in HCPs’ social cognitions over time. Future CMCL evaluations should measure additional implementation variables so that the key ingredients for ‘Changing Minds’ can continue to be investigated.
PMCID: PMC3945607  PMID: 24581329
Educational intervention; Healthcare professionals; Leisure-time physical activity; Physical activity prescription; Physical disability; Theory of Planned Behaviour
25.  Comparative Efficacy of Seven Psychotherapeutic Interventions for Patients with Depression: A Network Meta-Analysis 
PLoS Medicine  2013;10(5):e1001454.
Jürgen Barth and colleagues use network meta-analysis - a novel methodological approach - to reexamine the comparative efficacy of seven psychotherapeutic interventions for adults with depression.
Please see later in the article for the Editors' Summary
Previous meta-analyses comparing the efficacy of psychotherapeutic interventions for depression were clouded by a limited number of within-study treatment comparisons. This study used network meta-analysis, a novel methodological approach that integrates direct and indirect evidence from randomised controlled studies, to re-examine the comparative efficacy of seven psychotherapeutic interventions for adult depression.
Methods and Findings
We conducted systematic literature searches in PubMed, PsycINFO, and Embase up to November 2012, and identified additional studies through earlier meta-analyses and the references of included studies. We identified 198 studies, including 15,118 adult patients with depression, and coded moderator variables. Each of the seven psychotherapeutic interventions was superior to a waitlist control condition with moderate to large effects (range d = −0.62 to d = −0.92). Relative effects of different psychotherapeutic interventions on depressive symptoms were absent to small (range d = 0.01 to d = −0.30). Interpersonal therapy was significantly more effective than supportive therapy (d = −0.30, 95% credibility interval [CrI] [−0.54 to −0.05]). Moderator analysis showed that patient characteristics had no influence on treatment effects, but identified aspects of study quality and sample size as effect modifiers. Smaller effects were found in studies of at least moderate (Δd = 0.29 [−0.01 to 0.58]; p = 0.063) and large size (Δd = 0.33 [0.08 to 0.61]; p = 0.012) and those that had adequate outcome assessment (Δd = 0.38 [−0.06 to 0.87]; p = 0.100). Stepwise restriction of analyses by sample size showed robust effects for cognitive-behavioural therapy, interpersonal therapy, and problem-solving therapy (all d>0.46) compared to waitlist. Empirical evidence from large studies was unavailable or limited for other psychotherapeutic interventions.
Overall our results are consistent with the notion that different psychotherapeutic interventions for depression have comparable benefits. However, the robustness of the evidence varies considerably between different psychotherapeutic treatments.
Please see later in the article for the Editors' Summary
Editors' Summary
Depression is a very common condition. One in six people will experience depression at some time during their life. People who are depressed have recurrent feelings of sadness and hopelessness and might feel that life is no longer worth living. The condition can last for months and often includes physical symptoms such as headaches, sleeping problems, and weight gain or loss. Treatment of depression can include non-drug treatments (psychotherapy), antidepressant drugs, or a combination of the two. Especially for people with mild or intermediate depression, psychotherapy is often considered the preferred first option. Psychotherapy describes a range of different psychotherapies, and a number of established types of psychotherapies have all shown to work for at least some patients.
Why Was This Study Done?
While it is broadly accepted that psychotherapy can help people with depression, the question of which type of psychotherapy works best for most patients remains controversial. While many scientific studies have compared one psychotherapy with control conditions, there have been few studies that directly compared multiple treatments. Without such direct comparisons, it has been difficult to establish the respective merits of the different types of psychotherapy. Taking advantage of a recently developed method called “network meta-analysis,” the authors re-examine the evidence on seven different types of psychotherapy to see how well they have been shown to work and whether some work better than others.
What Did the Researchers Do and Find?
The researchers looked at seven different types of psychotherapy, which they defined as follows. “Interpersonal psychotherapy” is short and highly structured, using a manual to focus on interpersonal issues in depression. “Behavioral activation” raises the awareness of pleasant activities and seeks to increase positive interactions between the patient and his or her environment. “Cognitive behavioral therapy” focuses on a patient's current negative beliefs, evaluates how they affect current and future behavior, and attempts to restructure the beliefs and change the outlook. “Problem solving therapy” aims to define a patient's problems, propose multiple solutions for each problem, and then select, implement, and evaluate the best solution. “Psychodynamic therapy” focuses on past unresolved conflicts and relationships and the impact they have on a patient's current situation. In “social skills therapy,” patients are taught skills that help to build and maintain healthy relationships based on honesty and respect. “Supportive counseling” is a more general therapy that aims to get patients to talk about their experiences and emotions and to offer empathy without suggesting solutions or teaching new skills.
The researchers started with a systematic search of the medical literature for relevant studies. The search identified 198 articles that reported on such clinical trials. The trials included a total of 15,118 patients and compared one of the seven psychotherapies either with another one or with a common “control intervention”. In most cases, the control (no psychotherapy) was deferral of treatment by “wait-listing” patients or continuing “usual care.” With network meta-analysis they were able to summarize the results of all these trials in a meaningful way. They did this by integrating direct comparisons of several psychotherapies within the same trial (where those were available) with indirect comparisons across all trials (using no psychotherapy as a control intervention).
Based on the combined trial results, all seven psychotherapies tested were better than wait-listing or usual care, and the differences were moderate to large, meaning that the average person in the group that received therapy was better off than about half of the patients in the control group. When comparing the therapies with each other, the researchers saw small or no differences, meaning that none of them really stood out as much better or much worse than the others. They also found that the treatments worked equally well for different patient groups with depression (younger or older patients, or mothers who had depression after having given birth). Similarly, they saw no big differences when comparing individual with group therapy, or person-to-person with internet-based interactions between therapist and patient.
However, they did find that smaller and less rigorous studies generally found larger benefits of psychotherapies, and most of the studies included in the analysis were small. Only 36 of the studies had at least 50 patients who received the same treatment. When they restricted their analysis to those studies, the researchers still saw clear benefits of cognitive-behavioral therapy, interpersonal therapy, and problem-solving therapy, but not for the other four therapies.
What Do these Findings Mean?
Similar to earlier attempts to summarize and make sense of the many study results, this one finds benefits for all of the seven psychotherapies examined, and none of them stood as being much better than some or all others. The scientific support for being beneficial was stronger for some therapies, mostly because they had been tested more often and in larger studies.
Treatments with proven benefits still do not necessarily work for all patients, and which type of psychotherapy might work best for a particular patient likely depends on that individual. So overall this analysis suggests that patients with depression and their doctors should consider psychotherapies and explore which of the different types might be best suited for a particular patient.
The study also points to the need for further research. Whereas depression affects large numbers of people around the world, all of the trials identified were conducted in rich countries and Western societies. Trials in different settings are essential to inform treatment of patients worldwide. In addition, large high-quality studies should further explore the potential benefits of some of therapies for which less support currently exists. Where possible, future studies should compare psychotherapies with one another, because all of them have benefits, and it would not be ethical to withhold such beneficial treatment from patients.
Additional Information
Please access these Web sites via the online version of this summary at
The US National Institute of Mental Health provides information on all aspects of depression (in English and Spanish); information on psychotherapy includes information on its most common forms
The UK National Health Service Choices website also provides detailed information about depression and includes personal stories about depression
The UK nonprofit Mind provides information on depression, including an explanation of the most common psychotherapies in the UK
MedlinePlus provides links to other resources about depression (in English and Spanish)
The UK nonprofit has a unique database of personal and patient experiences on depression
PMCID: PMC3665892  PMID: 23723742

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