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1.  Determinants of exercise adherence and maintenance among cancer survivors: a systematic review 
For an exercise intervention to be successful, it is important that cancer survivors adhere to the prescribed program. To be able to improve adherence and to preserve achieved beneficial effects, insights into the relevant and modifiable determinants is important. Therefore, we aimed to systematically review determinants of exercise adherence and maintenance in cancer survivors using a socio-ecological approach.
Studies were identified in PubMed, Embase, PsycINFO and SPORTDiscus up to July 2013. We included full-text articles that: 1) were conducted among adult cancer survivors; 2) quantitatively assessed factors associated with intervention adherence and maintenance, and 3) were published in English. The methodological quality of the selected studies was examined. A best evidence synthesis was applied.
Eighteen studies were included. Median methodological quality was 53% and ranged from 21-78% of maximum score. Twelve studies focused on determinants of exercise adherence and evaluated 71 potential determinants: 29 demographic and clinical, 27 psychological, ten physical, four social factors, and one environmental factor. Six studies focused on determinants of exercise maintenance after completion of an intervention, and investigated 63 factors: 22 demographic and clinical, 28 psychosocial, nine physical, three social and one environmental factor. We found moderate evidence for a positive association between exercise history and exercise adherence. Inconsistent findings were found for age, gender and education as well as for psychological factors such as stage of change, perceived behavioral control, self-efficacy, extraversion, attitude, intention, fatigue, and quality of life, and physical factors including cardiovascular fitness, body mass index, and baseline physical activity.
Exercise history is positively associated with exercise adherence. Future trials should further study the influence of social and environmental determinants on exercise adherence and maintenance in addition to demographic, psychological and physical determinants.
doi:10.1186/1479-5868-11-80
PMCID: PMC4096543  PMID: 24989069
Physical activity; Exercise; Intervention adherence; Determinants; Neoplasms; Behavior; Systematic review
2.  Return to work of workers without a permanent employment contract, sick-listed due to a common mental disorder: design of a randomised controlled trial 
BMC Public Health  2014;14:594.
Background
Workers without a permanent employment contract represent a vulnerable group within the working population. Mental disorders are a major cause of sickness absence within this group. Common mental disorders are stress-related, depressive and anxiety disorders. To date, little attention has been paid to effective return to work interventions for this type of sick-listed workers. Therefore, a participatory supportive return to work program has been developed. It combines elements of a participatory return to work program, integrated care and direct placement in a competitive job.
The objective of this paper is to describe the design of a randomised controlled trial to evaluate the cost-effectiveness of this program compared to care as usual.
Methods/Design
The cost-effectiveness of the participatory supportive return to work program will be examined in a randomised controlled trial with a follow-up of twelve months.
The program strongly involves the sick-listed worker in the identification of obstacles for return to work and possible solutions, resulting in a consensus based action plan. This plan will be used as a starting point for the search of suitable competitive employment with support of a rehabilitation agency. During this process the insurance physician of the sick-listed worker contacts other caregivers to promote integrated care.
Workers eligible to participate in this study have no permanent employment contract, have applied for a sickness benefit at the Dutch Social Security Agency and are sick-listed between two and fourteen weeks due to mental health problems.
The primary outcome measure is the duration until first sustainable return to work in a competitive job. Outcomes are measured at baseline and after three, six, nine and twelve months.
Discussion
If the participatory supportive return to work program proves to be cost-effective, the social security system, the sick-listed worker and society as a whole will benefit. A cost-effective return to work program will lead to a reduction of costs related to sickness absence. For the sick-listed worker a cost-effective program results in earlier sustainable return to work, which can be associated with both social and health benefits.
Trial registration
The trial registration number and date is NTR3563, August 7, 2012.
doi:10.1186/1471-2458-14-594
PMCID: PMC4061521  PMID: 24919561
Return to work; Intervention; Sickness absence; Common mental disorders; Unemployed workers; Temporary agency workers; Fixed-term contract workers; Vulnerable workers; Occupational health care; Social security; Randomised controlled trial
3.  Short-Term Effects of a Web-Based Guided Self-Help Intervention for Employees With Depressive Symptoms: Randomized Controlled Trial 
Background
Depressive disorders are highly prevalent in the working population and are associated with excessive costs. The evidence for effective worker-directed interventions for employees with depressive symptoms is limited. Treating employees with depressive symptoms before sick leave via the Internet could be beneficial and cost saving.
Objective
In this study, we developed and tested the effectiveness of a Web-based guided self-help course for employees with depressive symptoms. We report on the posttreatment effectiveness of the intervention.
Methods
This study is a two-arm randomized controlled trial comparing a Web-based guided self-help course to care as usual (CAU). We recruited employees from 6 different companies via the companies’ intranet and posters. The main inclusion criterion was elevated depressive symptoms as measured by a score of ≥16 on the Center for Epidemiological Studies Depression scale (CES-D). The intervention (Happy@Work) was based on problem-solving treatment and cognitive therapy and consisted of 6 weekly lessons. Participants were asked to submit their weekly assignment via the website after completion. They subsequently received feedback from a coach via the website. Self-report questionnaires on depressive symptoms (CES-D; primary outcome), anxiety measured by the Hospital Anxiety and Depression Scale (HADS), burnout measured by the Maslach Burnout Inventory (MBI), and work performance measured by the Health and Work Performance Questionnaire (HPQ; secondary outcomes) were completed at baseline and at posttreatment.
Results
A total of 231 employees were randomized to either the intervention group (n=116) or CAU (n=115).The posttreatment assessment was completed by 171 (74.0%) participants. Both the intervention and the CAU group showed significant improvements in the primary outcome of depressive symptoms, but no differences between the conditions was found (d=0.16, 95% CI –0.10 to 0.41, P=.29). Significant but small effects in favor of the intervention group were found for anxiety symptoms (d=0.16, 95% CI –0.09 to 0.42, P=.04) and exhaustion (d=0.17, 95% CI –0.09 to 0.43, P=.02).
Conclusions
This study showed that a Web-based guided self-help course for employees with depressive symptoms was not more effective in reducing depressive symptoms among employees than CAU. Large improvements in depressive symptoms in the CAU group were unforeseen and potential explanations are discussed.
doi:10.2196/jmir.3185
PMCID: PMC4026573  PMID: 24800966
depression, employees, occupational therapy, Internet, prevention
4.  Long-Term Effect of a School-Based Physical Activity Program (KISS) on Fitness and Adiposity in Children: A Cluster-Randomized Controlled Trial 
PLoS ONE  2014;9(2):e87929.
Background
School-based intervention studies promoting a healthy lifestyle have shown favorable immediate health effects. However, there is a striking paucity on long-term follow-ups. The aim of this study was therefore to assess the 3 yr-follow-up of a cluster-randomized controlled school-based physical activity program over nine month with beneficial immediate effects on body fat, aerobic fitness and physical activity.
Methods and Findings
Initially, 28 classes from 15 elementary schools in Switzerland were grouped into an intervention (16 classes from 9 schools, n = 297 children) and a control arm (12 classes from 6 schools, n = 205 children) after stratification for grade (1st and 5th graders). Three years after the end of the multi-component physical activity program of nine months including daily physical education (i.e. two additional lessons per week on top of three regular lessons), short physical activity breaks during academic lessons, and daily physical activity homework, 289 (58%) participated in the follow-up. Primary outcome measures included body fat (sum of four skinfolds), aerobic fitness (shuttle run test), physical activity (accelerometry), and quality of life (questionnaires). After adjustment for grade, gender, baseline value and clustering within classes, children in the intervention arm compared with controls had a significantly higher average level of aerobic fitness at follow-up (0.373 z-score units [95%-CI: 0.157 to 0.59, p = 0.001] corresponding to a shift from the 50th to the 65th percentile between baseline and follow-up), while the immediate beneficial effects on the other primary outcomes were not sustained.
Conclusions
Apart from aerobic fitness, beneficial effects seen after one year were not maintained when the intervention was stopped. A continuous intervention seems necessary to maintain overall beneficial health effects as reached at the end of the intervention.
Trial Registration
ControlledTrials.com ISRCTN15360785
doi:10.1371/journal.pone.0087929
PMCID: PMC3912178  PMID: 24498404
5.  Biological, socio-demographic, work and lifestyle determinants of sitting in young adult women: a prospective cohort study 
Background
Sitting is associated with health risks. Factors that influence sitting are however not well understood. The aim was to examine the biological, socio-demographic, work-related and lifestyle determinants of sitting time (including during transport, work and leisure) in young adult Australian women.
Methods
Self-reported data from 11,676 participants (aged 22–27 years in 2000) in the Australian Longitudinal Study on Women’s Health were collected over 9 years in 2000, 2003, 2006 and 2009. Generalised Estimating Equations were used to examine univariable and multivariable associations of body mass index (BMI), country of birth, area of residence, education, marital status, number of children, occupational status, working hours, physical activity, smoking, alcohol intake and stress with week- and weekend-day sitting time.
Results
Compared with women in the respective referent categories, (1) women with higher BMI, those born in Asia, those with less than University level education, doing white collar work, working 41–48 hours a week, current smokers, non, rare or risky/high risk drinkers and those being somewhat stressed had significantly higher sitting time; and (2) women living in rural and remote areas, partnered women, those with children, those without a paid job and blue collar workers, those working less than 34 hours a week, and active women had significantly lower sitting time.
Conclusions
Among young adult Australian women, those with higher BMI, those born in Asia, those with higher level occupations and long working hours, were most at risk of higher sitting time. These results can be used to identify at-risk groups and inform intervention development.
doi:10.1186/1479-5868-11-7
PMCID: PMC3904408  PMID: 24457004
Epidemiology; Prospective studies; Sedentary lifestyle; Women’s health
6.  The implementation effectiveness of the ‘Strengthen your ankle’ smartphone application for the prevention of ankle sprains: design of a randomized controlled trial 
Background
Ankle sprains continue to pose a significant burden to the individual athlete, as well as to society as a whole. However, despite ankle sprains being the single most common sports injury and despite an active approach by various Dutch organisations in implementing preventive measures, large-scale community uptake of these preventive measures, and thus actual prevention of ankle sprains, is lagging well behind. In an attempt to bridge this implementation gap, the Dutch Consumer Safety Institute VeiligheidNL developed a freely available interactive App (‘Strenghten your ankle’ translated in Dutch as: ‘Versterk je enkel; available for iOS and Android) that contains - next to general advice on bracing and taping - a proven cost-effective neuromuscular program. The ‘Strengthen your ankle’ App has not been evaluated against the ‘regular’ prevention approach in which the neuromuscular program is advocated through written material. The aim of the current project is to evaluate the implementation value of the ‘Strengthen your ankle’ App as compared to the usual practice of providing injured athletes with written materials. In addition, as a secondary outcome measure, the cost-effectiveness will be assessed against usual practice.
Methods/Design
The proposed study will be a randomised controlled trial. After stratification for medical caregiver, athletes will be randomised to two study groups. One group will receive a standardized eight-week proprioceptive training program that has proven to be cost-effective to prevent recurrent ankle injuries, consisting of a balance board (machU/ MSG Europe BVBA), and a traditional instructional booklet. The other group will receive the same exercise program and balance board. However, for this group the instructional booklet is exchanged by the interactive ‘Strengthen your ankle’ App.
Discussion
This trial is the first randomized controlled trial to study the implementation effectiveness of an App for proprioceptive balance board training program in comparison to a traditional printed instruction booklet, with the recurrence of ankle sprains among athletes as study outcome. Results of this study could possibly lead to changes in practical guidelines on the treatment of ankle sprains and in the use of mobile applications for injury prevention. Results will become available in 2014.
Trial registration
The Netherlands National Trial Register NTR4027. The NTR is part of the WHO Primary Registries.
doi:10.1186/1471-2474-15-2
PMCID: PMC3923004  PMID: 24393146
Mobile health; Ankle sprains; Ankle injury; Prevention; Neuromuscular training
7.  Associations between overweight, obesity, health measures and need for recovery in office employees: a cross-sectional analysis 
BMC Public Health  2013;13:1207.
Background
With both a high need for recovery (NFR) and overweight and obesity being a potential burden for organizations (e.g. productivity loss and sickness absence), the aim of this paper was to examine the associations between overweight and obesity and several other health measures and NFR in office workers.
Methods
Baseline data of 412 office employees participating in a randomised controlled trial aimed at improving NFR in office workers were used. Associations between self-reported BMI categories (normal body weight, overweight, obesity) and several other health measures (general health, mental health, sleep quality, stress and vitality) with NFR were examined. Unadjusted and adjusted linear regression analyses were performed and adjusted for age, education and job demands. In addition, we adjusted for general health in the association between overweight and obesity and NFR.
Results
A significant positive association was observed between stress and NFR (B = 18.04, 95%CI:14.53-21.56). General health, mental health, sleep quality and vitality were negatively associated with NFR (p < 0.001). Analyses also showed a significant positive association between obesity and NFR (B = 8.77, 95%CI:0.01-17.56), but not between overweight and NFR.
Conclusions
The findings suggest that self-reported stress is, and obesity may be, associated with a higher NFR. Additionally, the results imply that health measures that indicate a better health are associated with a lower NFR.
Trial registration
The trial is registered at the Dutch Trial Register (NTR) under trial registration number: NTR2553.
doi:10.1186/1471-2458-13-1207
PMCID: PMC3890611  PMID: 24359267
Cross-sectional study; Need for recovery; Employees; Overweight; Obesity; Health measures
8.  Exploring facilitating factors and barriers to the nationwide dissemination of a Dutch school-based obesity prevention program “DOiT”: a study protocol 
BMC Public Health  2013;13:1201.
Background
The evidence-based Dutch Obesity Intervention in Teenagers (DOiT) program is a school-based obesity prevention program for 12 to 14-year olds attending the first two years of prevocational education. This paper describes the study protocol applied to evaluate (a) the nationwide dissemination process of DOiT in the Netherlands, and (b) the relationship between quality of implementation and effectiveness during nationwide dissemination of the program in the Netherlands.
Methods
In order to explore facilitating factors and barriers for dissemination of DOiT, we monitored the process of adoption, implementation and continuation of the DOiT program among 20 prevocational schools in the Netherlands. The study was an observational study using qualitative (i.e. semi-structured interviews) and quantitative methods (i.e. questionnaires and logbooks). Eight process indicators were assessed: recruitment, context, reach, dosage, fidelity, satisfaction, effectiveness and continuation. All teachers, students and parents involved in the implementation of the program were invited to participate in the study. As part of the process evaluation, a cluster-controlled trial with ten control schools was conducted to evaluate the effectiveness of the program on students’ anthropometry and energy balance-related behaviours and its association with quality of implementation.
Discussion
The identified impeding and facilitating factors will contribute to an adjusted strategy promoting adoption, implementation and continuation of the DOiT program to ensure optimal use and, thereby, prevention of obesity in Dutch adolescents.
Trial registration
Current Controlled Trials ISRCTN92755979.
doi:10.1186/1471-2458-13-1201
PMCID: PMC3878240  PMID: 24355056
Dissemination; Implementation; Adolescent; Overweight; Obesity; Schools; Prevention; Process evaluation
9.  What is actually measured in process evaluations for worksite health promotion programs: a systematic review 
BMC Public Health  2013;13:1190.
Background
Numerous worksite health promotion program (WHPPs) have been implemented the past years to improve employees’ health and lifestyle (i.e., physical activity, nutrition, smoking, alcohol use and relaxation). Research primarily focused on the effectiveness of these WHPPs. Whereas process evaluations provide essential information necessary to improve large scale implementation across other settings. Therefore, this review aims to: (1) further our understanding of the quality of process evaluations alongside effect evaluations for WHPPs, (2) identify barriers/facilitators affecting implementation, and (3) explore the relationship between effectiveness and the implementation process.
Methods
Pubmed, EMBASE, PsycINFO, and Cochrane (controlled trials) were searched from 2000 to July 2012 for peer-reviewed (randomized) controlled trials published in English reporting on both the effectiveness and the implementation process of a WHPP focusing on physical activity, smoking cessation, alcohol use, healthy diet and/or relaxation at work, targeting employees aged 18-65 years.
Results
Of the 307 effect evaluations identified, twenty-two (7.2%) published an additional process evaluation and were included in this review. The results showed that eight of those studies based their process evaluation on a theoretical framework. The methodological quality of nine process evaluations was good. The most frequently reported process components were dose delivered and dose received. Over 50 different implementation barriers/facilitators were identified. The most frequently reported facilitator was strong management support. Lack of resources was the most frequently reported barrier. Seven studies examined the link between implementation and effectiveness. In general a positive association was found between fidelity, dose and the primary outcome of the program.
Conclusions
Process evaluations are not systematically performed alongside effectiveness studies for WHPPs. The quality of the process evaluations is mostly poor to average, resulting in a lack of systematically measured barriers/facilitators. The narrow focus on implementation makes it difficult to explore the relationship between effectiveness and implementation. Furthermore, the operationalisation of process components varied between studies, indicating a need for consensus about defining and operationalising process components.
doi:10.1186/1471-2458-13-1190
PMCID: PMC3890539  PMID: 24341605
Implementation; Worksite health promotion program; Systematic review; Process evaluation; Lifestyle intervention; Determinants of implementation; Barriers and facilitators
10.  Effects of a Web-Based Intervention on Physical Activity and Metabolism in Older Adults: Randomized Controlled Trial 
Background
Lack of physical activity leads to detrimental changes in body composition and metabolism, functional decline, and increased risk of disease in old age. The potential of Web-assisted interventions for increasing physical activity and improving metabolism in older individuals holds great promise but to our knowledge it has not been studied.
Objective
The goal of our study was to assess whether a Web-based intervention increases physical activity and improves metabolic health in inactive older adults.
Methods
We conducted a 3-month randomized, waitlist-controlled trial in a volunteer sample of 235 inactive adults aged 60-70 years without diabetes. The intervention group received the Internet program Philips DirectLife, which was directed at increasing physical activity using monitoring and feedback by accelerometer and digital coaching. The primary outcome was relative increase in physical activity measured objectively using ankle- and wrist-worn accelerometers. Secondary outcomes of metabolic health included anthropometric measures and parameters of glucose metabolism.
Results
In total, 226 participants (97%) completed the study. At the ankle, activity counts increased by 46% (standard error [SE] 7%) in the intervention group, compared to 12% (SE 3%) in the control group (P difference<.001). Measured at the wrist, activity counts increased by 11% (SE 3%) in the intervention group and 5% (SE 2%) in the control group (P difference=.11). After processing of the data, this corresponded to a daily increase of 11 minutes in moderate-to-vigorous activity in the intervention group versus 0 minutes in the control group (P difference=.001). Weight decreased significantly more in the intervention group compared to controls (−1.5 kg vs −0.8 kg respectively, P=.046), as did waist circumference (−2.3 cm vs −1.3 cm respectively, P=.036) and fat mass (−0.6% vs 0.07% respectively, P=.025). Furthermore, insulin and HbA1c levels were significantly more reduced in the intervention group compared to controls (both P<.05).
Conclusions
This was the first study to show that in inactive older adults, a 3-month Web-based physical activity intervention was effective in increasing objectively measured daily physical activity and improving metabolic health. Such Web-based interventions provide novel opportunities for large scale prevention of metabolic deregulation in our rapidly aging population.
Trial Registration
Dutch Trial Registry: NTR 3045; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3045 (Archived by WebCite at http://www.webcitation.org/6KPw52dCc).
doi:10.2196/jmir.2843
PMCID: PMC3841355  PMID: 24195965
physical activity; Internet; accelerometry; aging; metabolism; self-monitoring
11.  Research priorities for child and adolescent physical activity and sedentary behaviours: an international perspective using a twin-panel Delphi procedure 
Background
The quantity and quality of studies in child and adolescent physical activity and sedentary behaviour have rapidly increased, but research directions are often pursued in a reactive and uncoordinated manner.
Aim
To arrive at an international consensus on research priorities in the area of child and adolescent physical activity and sedentary behaviour.
Methods
Two independent panels, each consisting of 12 experts, undertook three rounds of a Delphi methodology. The Delphi methodology required experts to anonymously answer questions put forward by the researchers with feedback provided between each round.
Results
The primary outcome of the study was a ranked set of 29 research priorities that aimed to be applicable for the next 10 years. The top three ranked priorities were: developing effective and sustainable interventions to increase children’s physical activity long-term; policy and/or environmental change and their influence on children’s physical activity and sedentary behaviour; and prospective, longitudinal studies of the independent effects of physical activity and sedentary behaviour on health.
Conclusions
These research priorities can help to guide decisions on future research directions.
doi:10.1186/1479-5868-10-112
PMCID: PMC3853883  PMID: 24228891
Physical activity; Sedentary behaviour; Research priorities; Children; Adolescents
12.  The incidence of rugby-related catastrophic injuries (including cardiac events) in South Africa from 2008 to 2011: a cohort study 
BMJ Open  2013;3(2):e002475.
Objectives
To establish an accurate and comprehensive injury incidence registry of all rugby union-related catastrophic events in South Africa between 2008 and 2011. An additional aim was to investigate correlates associated with these injuries.
Design
Prospective.
Setting
The South African amateur and professional rugby-playing population.
Participants
An estimated 529 483 Junior and 121 663 Senior rugby union (‘rugby’) players (population at risk).
Outcome measures
Annual average incidences of rugby-related catastrophic injuries by type (cardiac events, traumatic brain and acute spinal cord injuries (ASCIs)) and outcome (full recoveries—fatalities). Playing level (junior and senior levels), position and event (phase of play) were also assessed.
Results
The average annual incidence of ASCIs and Traumatic Brain Injuries combined was 2.00 per 100 000 players (95% CI 0.91 to 3.08) from 2008 to 2011. The incidence of ASCIs with permanent outcomes was significantly higher at the Senior level (4.52 per 100 000 players, 95% CI 0.74 to 8.30) than the Junior level (0.24 per 100 000 players, 95% CI 0 to 0.65) during this period. The hooker position was associated with 46% (n=12 of 26) of all permanent ASCI outcomes, the majority of which (83%) occurred during the scrum phase of play.
Conclusions
The incidence of rugby-related catastrophic injuries in South Africa between 2008 and 2011 is comparable to that of other countries and to most other collision sports. The higher incidence rate of permanent ASCIs at the Senior level could be related to the different law variations or characteristics (eg, less regular training) compared with the Junior level. The hooker and scrum were associated with high proportions of permanent ASCIs. The BokSmart injury prevention programme should focus efforts on these areas (Senior level, hooker and scrum) and use this study as a reference point for the evaluation of the effectiveness of the programme.
doi:10.1136/bmjopen-2012-002475
PMCID: PMC3586133  PMID: 23447464
PREVENTIVE MEDICINE; EPIDEMIOLOGY; SPORTS MEDICINE; AUDIT
13.  Web-based guided self-help for employees with depressive symptoms (Happy@Work): design of a randomized controlled trial 
BMC Psychiatry  2013;13:61.
Background
Depressive disorders are highly prevalent in the working population and are associated with excessive costs for both society and companies. Effective treatment for employees with depressive symptoms in occupational health care is limited. The purpose of this study is to investigate the effectiveness and cost-effectiveness of an indicated preventive web-based guided self-help course for employees with depressive symptoms.
Methods
The study is a two-arm randomized controlled trial comparing a web-based guided self-help course with care-as-usual. The self-help course consists of 6 weekly lessons. Weekly support will be provided by a coach via the website. Subjects in the care-as-usual group do not receive any treatment in addition to regular care. 200 white collar workers from several national and international companies in the Netherlands will be recruited via different methods such as banners on the company’s intranet, pamphlets and posters. Subjects will be included when they: have elevated depressive symptoms (score ≥16 on the Center for Epidemiologic Studies Depression scale), are 18 years of age or older, have access to the Internet and can be contacted via e-mail. Exclusion criteria are: partial or full work absenteeism, a legal labor dispute with the employer and receiving treatment from the company’s occupational health care at study entrance.
The primary outcome is depressive symptoms. Secondary outcomes include work absenteeism, work performance, burnout, anxiety, quality of life, health care use and production losses. Outcome data will be collected at 8 weeks, 6 months, and 12 months after baseline. Analyses will be based on the intention-to-treat principle. The cost-effectiveness analyses will be performed from a societal and a company’s perspective. A process evaluation will be conducted alongside the study.
Discussion
This study evaluates the effectiveness and cost-effectiveness of a web-based guided self-help course for employees with depressive symptoms. This study could stimulate the use of e-mental health interventions in the worksite setting.
Trial registration
Nederlands Trial Register (NTR): TC2993
doi:10.1186/1471-244X-13-61
PMCID: PMC3599070  PMID: 23418886
Internet; Depression; Absenteeism; Employees; Occupational therapy; Self-help; Cognitive therapy; Problem solving; Randomized trial.
14.  Can Multiple Lifestyle Behaviours Be Improved in People with Familial Hypercholesterolemia? Results of a Parallel Randomised Controlled Trial 
PLoS ONE  2012;7(12):e50032.
Objective
To evaluate the efficacy of an individualised tailored lifestyle intervention on physical activity, dietary intake, smoking and compliance to statin therapy in people with Familial Hypercholesterolemia (FH).
Methods
Adults with FH (n = 340) were randomly assigned to a usual care control group or an intervention group. The intervention consisted of web-based tailored lifestyle advice and face-to-face counselling. Physical activity, fat, fruit and vegetable intake, smoking and compliance to statin therapy were self-reported at baseline and after 12 months. Regression analyses were conducted to examine between-group differences. Intervention reach, dose and fidelity were assessed.
Results
In both groups, non-significant improvements in all lifestyle behaviours were found. Post-hoc analyses showed a significant decrease in saturated fat intake among women in the intervention group (β = −1.03; CI −1.98/−0.03). In the intervention group, 95% received a log on account, of which 49% logged on and completed one module. Nearly all participants received face-to-face counselling and on average, 4.2 telephone booster calls. Intervention fidelity was low.
Conclusions
Individually tailored feedback is not superior to no intervention regarding changes in multiple lifestyle behaviours in people with FH. A higher received dose of computer-tailored interventions should be achieved by uplifting the website and reducing the burden of screening questionnaires. Counsellor training should be more extensive.
Trial Registration
Dutch Trial Register NTR1899
doi:10.1371/journal.pone.0050032
PMCID: PMC3520968  PMID: 23251355
15.  Physical and psychosocial benefits of yoga in cancer patients and survivors, a systematic review and meta-analysis of randomized controlled trials 
BMC Cancer  2012;12:559.
Background
This study aimed to systematically review the evidence from randomized controlled trials (RCTs) and to conduct a meta-analysis of the effects of yoga on physical and psychosocial outcomes in cancer patients and survivors.
Methods
A systematic literature search in ten databases was conducted in November 2011. Studies were included if they had an RCT design, focused on cancer patients or survivors, included physical postures in the yoga program, compared yoga with a non-exercise or waitlist control group, and evaluated physical and/or psychosocial outcomes. Two researchers independently rated the quality of the included RCTs, and high quality was defined as >50% of the total possible score. Effect sizes (Cohen’s d) were calculated for outcomes studied in more than three studies among patients with breast cancer using means and standard deviations of post-test scores of the intervention and control groups.
Results
Sixteen publications of 13 RCTs met the inclusion criteria, of which one included patients with lymphomas and the others focused on patients with breast cancer. The median quality score was 67% (range: 22–89%). The included studies evaluated 23 physical and 20 psychosocial outcomes. Of the outcomes studied in more than three studies among patients with breast cancer, we found large reductions in distress, anxiety, and depression (d = −0.69 to −0.75), moderate reductions in fatigue (d = −0.51), moderate increases in general quality of life, emotional function and social function (d = 0.33 to 0.49), and a small increase in functional well-being (d = 0.31). Effects on physical function and sleep were small and not significant.
Conclusion
Yoga appeared to be a feasible intervention and beneficial effects on several physical and psychosocial symptoms were reported. In patients with breast cancer, effect size on functional well-being was small, and they were moderate to large for psychosocial outcomes.
doi:10.1186/1471-2407-12-559
PMCID: PMC3571972  PMID: 23181734
Yoga; Randomized controlled trial; Physical function; Psychosocial function; Quality of life; Cancer
16.  Mediators of the effect of the JUMP-in intervention on physical activity and sedentary behavior in Dutch primary schoolchildren from disadvantaged neighborhoods 
Background
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.
Methods
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.
Results
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.
Conclusions
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
ISRCTN17489378
doi:10.1186/1479-5868-9-131
PMCID: PMC3541111  PMID: 23130806
Mediating; Working mechanisms; Youth; Intervention; Physical activity; Sport; Sedentary; Sitting; Television
17.  eHealth Program to Empower Patients in Returning to Normal Activities and Work After Gynecological Surgery: Intervention Mapping as a Useful Method for Development 
Background
Full recovery after gynecological surgery takes much longer than expected regardless of surgical technique or the level of invasiveness. After discharge, detailed convalescence recommendations are not provided to patients typically, and postoperative care is fragmented, poorly coordinated, and given only on demand. For patients, this contributes to irrational beliefs and avoidance of resumption of activities and can result in a prolonged sick leave.
Objective
To develop an eHealth intervention that empowers gynecological patients during the perioperative period to obtain timely return to work (RTW) and prevent work disability.
Methods
The intervention mapping (IM) protocol was used to develop the eHealth intervention. A literature search about behavioral and environmental conditions of prolonged sick leave and delayed RTW in patients was performed. Patients’ needs, attitudes, and beliefs regarding postoperative recovery and resumption of work were identified through focus group discussions. Additionally, a literature search was performed to obtain determinants, methods, and strategies for the development of a suitable interactive eHealth intervention to empower patients to return to normal activities after gynecological surgery, including work. Finally, the eHealth intervention was evaluated by focus group participants, medical doctors, and eHealth specialists through questionnaires.
Results
Twenty-one patients participated in the focus group discussions. Sufficient, uniform, and tailored information regarding surgical procedures, complications, and resumption of activities and work were considered most essential. Knowing who to contact in case of mental or physical complaints, and counseling and tools for work reintegration were also considered important. Finally, opportunities to exchange experiences with other patients were a major issue. Considering the determinants of the Attitude–Social influence–self-Efficacy (ASE) model, various strategies based on a combination of theory and evidence were used, resulting in an eHealth intervention with different interactive functionalities including tailored convalescence recommendations and a video to communicate the most common pitfalls during the perioperative period to patients and employers. Fifteen patients in the focus groups, 11 physicians, and 3 eHealth specialists suggested points for improvement to optimize the usability of the eHealth intervention and judged it an approachable, appropriate, and attractive eHealth intervention to empower gynecological patients.
Conclusions
The IM protocol was a useful method to develop an eHealth intervention based on both theory and evidence. All patients and stakeholders judged the eHealth intervention to be a promising tool to empower gynecological patients during the perioperative period and to help them to return to normal activities and work.
doi:10.2196/jmir.1915
PMCID: PMC3510728  PMID: 23086834
eHealth intervention; interactive website; Internet; patient empowerment; intervention mapping; gynecological surgery; hysterectomy; laparoscopic adnexal surgery; return to work
18.  Steps that count! : The development of a pedometer-based health promotion intervention in an employed, health insured South African population 
BMC Public Health  2012;12:880.
Background
Physical activity (PA) has been identified as a central component in the promotion of health. PA programs can provide a low cost intervention opportunity, encouraging PA behavioral change while worksites have been shown to be an appropriate setting for implementing such health promotion programs. Along with these trends, there has been an emergence of the use of pedometers as a self-monitoring and motivational aid for PA.
This study determines the effectiveness of a worksite health promotion program comprising of a 10-week, pedometer-based intervention (“Steps that Count!”), and individualized email-based feedback to effect PA behavioral change.
Methods
The study is a randomized controlled trial in a worksite setting, using pedometers and individualized email-based feedback to increase steps per day (steps/d). Participant selection will be based on attendance at a corporate wellness event and information obtained, following the completion of a Health Risk Appraisal (HRA), in keeping with inclusion criteria for the study. All participants will, at week 1 (pre-intervention), be provided with a blinded pedometer to assess baseline levels of PA. Participants will be provided with feedback on pedometer data and identify strategies to improve daily PA towards current PA recommendations. Participants will thereafter be randomly assigned to the intervention group (INT) or control group (CTL). The INT will subsequently wear an un-blinded pedometer for 10 consecutive weeks.
Individualized feedback messages based on average steps per day, derived from pedometer data (INT) and general supportive/motivational messages (INT+CTL), will be provided via bi-weekly e-mails; blinded pedometer-wear will be conducted at week 12 (post-intervention: INT+CTL).
Discussion
The purpose of this paper is to outline the rationale behind, and the development of, an intervention aimed at improving ambulatory PA through pedometer use, combined with regular, individualized, email-based feedback. Pedometer-measured PA and individualized feedback may be a practical and easily applied intervention.
Trial registration
Number: DOH-27-0112-3951
doi:10.1186/1471-2458-12-880
PMCID: PMC3536647  PMID: 23075000
Pedometer; Health risk appraisal; Physical activity; Computer-based feedback
19.  Economic evaluation of a weight control program with e-mail and telephone counseling among overweight employees: a randomized controlled trial 
Background
Distance lifestyle counseling for weight control is a promising public health intervention in the work setting. Information about the cost-effectiveness of such interventions is lacking, but necessary to make informed implementation decisions. The purpose of this study was to perform an economic evaluation of a six-month program with lifestyle counseling aimed at weight reduction in an overweight working population with a two-year time horizon from a societal perspective.
Methods
A randomized controlled trial comparing a program with two modes of intervention delivery against self-help. 1386 Employees from seven companies participated (67% male, mean age 43 (SD 8.6) years, mean BMI 29.6 (SD 3.5) kg/m2). All groups received self-directed lifestyle brochures. The two intervention groups additionally received a workbook-based program with phone counseling (phone; n=462) or a web-based program with e-mail counseling (internet; n=464). Body weight was measured at baseline and 24 months after baseline. Quality of life (EuroQol-5D) was assessed at baseline, 6, 12, 18 and 24 months after baseline. Resource use was measured with six-monthly diaries and valued with Dutch standard costs. Missing data were multiply imputed. Uncertainty around differences in costs and incremental cost-effectiveness ratios was estimated by applying non-parametric bootstrapping techniques and graphically plotting the results in cost-effectiveness planes and cost-effectiveness acceptability curves.
Results
At two years the incremental cost-effectiveness ratio was €1009/kg weight loss in the phone group and €16/kg weight loss in the internet group. The cost-utility analysis resulted in €245,243/quality adjusted life year (QALY) and €1337/QALY, respectively. The results from a complete-case analysis were slightly more favorable. However, there was considerable uncertainty around all outcomes.
Conclusions
Neither intervention mode was proven to be cost-effective compared to self-help.
Trial registration
ISRCTN04265725
doi:10.1186/1479-5868-9-112
PMCID: PMC3499374  PMID: 22967224
Body weight; Cost-effectiveness; Cost-utility; Distance counseling; Intervention; Lifestyle; RCT; Workplace health promotion
20.  The design of a real-time formative evaluation of the implementation process of lifestyle interventions at two worksites using a 7-step strategy (BRAVO@Work) 
BMC Public Health  2012;12:619.
Background
Worksite health promotion programs (WHPPs) offer an attractive opportunity to improve the lifestyle of employees. Nevertheless, broad scale and successful implementation of WHPPs in daily practice often fails. In the present study, called BRAVO@Work, a 7-step implementation strategy was used to develop, implement and embed a WHPP in two different worksites with a focus on multiple lifestyle interventions.
This article describes the design and framework for the formative evaluation of this 7-step strategy under real-time conditions by an embedded scientist with the purpose to gain insight into whether this this 7-step strategy is a useful and effective implementation strategy. Furthermore, we aim to gain insight into factors that either facilitate or hamper the implementation process, the quality of the implemented lifestyle interventions and the degree of adoption, implementation and continuation of these interventions.
Methods and design
This study is a formative evaluation within two different worksites with an embedded scientist on site to continuously monitor the implementation process. Each worksite (i.e. a University of Applied Sciences and an Academic Hospital) will assign a participating faculty or a department, to implement a WHPP focusing on lifestyle interventions using the 7-step strategy. The primary focus will be to describe the natural course of development, implementation and maintenance of a WHPP by studying [a] the use and adherence to the 7-step strategy, [b] barriers and facilitators that influence the natural course of adoption, implementation and maintenance, and [c] the implementation process of the lifestyle interventions. All data will be collected using qualitative (i.e. real-time monitoring and semi-structured interviews) and quantitative methods (i.e. process evaluation questionnaires) applying data triangulation. Except for the real-time monitoring, the data collection will take place at baseline and after 6, 12 and 18 months.
Discussion
This is one of the few studies to extensively and continuously monitor the natural course of the implementation process of a WHPP by a formative evaluation using a mix of quantitative and qualitative methods on different organizational levels (i.e. management, project group, employees) with an embedded scientist on site.
Trial Registration
NTR2861
doi:10.1186/1471-2458-12-619
PMCID: PMC3490970  PMID: 22871020
Implementation strategy; Process evaluation; Formative evaluation; Qualitative study; Worksite health promotion; Embedded scientist; Data triangulation
21.  The development of the Be Active & Relax “Vitality in Practice” (VIP) project and design of an RCT to reduce the need for recovery in office employees 
BMC Public Health  2012;12:592.
Background
There is strong evidence to suggest that multiple work-related health problems are preceded by a higher need for recovery. Physical activity and relaxation are helpful in decreasing the need for recovery. This article aims to describe (1) the development and (2) the design of the evaluation of a daily physical activity and relaxation intervention to reduce the need for recovery in office employees.
Methods/Design
The study population will consist of employees of a Dutch financial service provider. The intervention was systematically developed, based on parts of the Intervention Mapping (IM) protocol. Assessment of employees needs was done by combining results of face-to-face interviews, a questionnaire and focus group interviews. A set of theoretical methods and practical strategies were selected which resulted in an intervention program consisting of Group Motivational Interviewing (GMI) supported by a social media platform, and environmental modifications. The Be Active & Relax program will be evaluated in a modified 2 X 2 factorial design. The environmental modifications will be pre-stratified and GMI will be randomised on department level. The program will be evaluated, using 4 arms: (1) GMI and environmental modifications; (2) environmental modifications; (3) GMI; (4) no intervention (control group). Questionnaire data on the primary outcome (need for recovery) and secondary outcomes (daily physical activity, sedentary behaviour, relaxation/detachment, work- and health-related factors) will be gathered at baseline (T0), at 6 months (T1), and at 12 months (T2) follow-up. In addition, an economic and a process evaluation will be performed.
Discussion
Reducing the need for recovery is hypothesized to be beneficial for employees, employers and society. It is assumed that there will be a reduction in need for recovery after 6 months and 12 months in the intervention group, compared to the control group. Results are expected in 2013.
Trial registration
Netherlands Trial Register (NTR): NTR2553
doi:10.1186/1471-2458-12-592
PMCID: PMC3487972  PMID: 22852835
Need for recovery; Relaxation; Physical activity; Environmental modifications; Group motivational interviewing; Employees; RCT
22.  No significant improvement of cardiovascular disease risk indicators by a lifestyle intervention in people with Familial Hypercholesterolemia compared to usual care: results of a randomised controlled trial 
BMC Research Notes  2012;5:181.
Background
People with Familial Hypercholesterolemia (FH) may benefit from lifestyle changes supporting their primary treatment of dyslipidaemia. This project evaluated the efficacy of an individualised tailored lifestyle intervention on lipids (low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), total cholesterol (TC) and triglycerides), systolic blood pressure, glucose, body mass index (BMI) and waist circumference in people with FH.
Methods
Adults with FH (n = 340), recruited from a Dutch cascade screening program, were randomly assigned to either a control group or an intervention group. The personalised intervention consisted of web-based tailored lifestyle advice and personal counselling. The control group received care as usual. Lipids, systolic blood pressure, glucose, BMI, and waist circumference were measured at baseline and after 12 months. Regression analyses were conducted to examine differences between both groups.
Results
After 12 months, no significant between-group differences of cardiovascular disease (CVD) risk indicators were observed. LDL-C levels had decreased in both the intervention and control group. This difference between intervention and control group was not statistically significant.
Conclusions
This project suggests that an individually tailored lifestyle intervention did not have an additional effect in improving CVD risk indicators among people with FH. The cumulative effect of many small improvements in all indicators on long term CVD risk remains to be assessed in future studies.
Trial registration
NTR1899 at ww.trialregister.nl
doi:10.1186/1756-0500-5-181
PMCID: PMC3392724  PMID: 22490761
23.  Cost-effectiveness of an exercise program during pregnancy to prevent gestational diabetes: Results of an economic evaluation alongside a randomised controlled trial 
Background
The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. GDM and the risks associated with GDM lead to increased health care costs and losses in productivity. The objective of this study is to evaluate whether the FitFor2 exercise program during pregnancy is cost-effective from a societal perspective as compared to standard care.
Methods
A randomised controlled trial (RCT) and simultaneous economic evaluation of the FitFor2 program were conducted. Pregnant women at risk for GDM were randomised to an exercise program to prevent high maternal blood glucose (n = 62) or to standard care (n = 59). The exercise program consisted of two sessions of aerobic and strengthening exercises per week. Clinical outcome measures were maternal fasting blood glucose levels, insulin sensitivity and infant birth weight. Quality of life was measured using the EuroQol 5-D and quality-adjusted life-years (QALYs) were calculated. Resource utilization and sick leave data were collected by questionnaires. Data were analysed according to the intention-to-treat principle. Missing data were imputed using multiple imputations. Bootstrapping techniques estimated the uncertainty surrounding the cost differences and incremental cost-effectiveness ratios.
Results
There were no statistically significant differences in any outcome measure. During pregnancy, total health care costs and costs of productivity losses were statistically non-significant (mean difference €1308; 95%CI €-229 - €3204). The cost-effectiveness analyses showed that the exercise program was not cost-effective in comparison to the control group for blood glucose levels, insulin sensitivity, infant birth weight or QALYs.
Conclusion
The twice-weekly exercise program for pregnant women at risk for GDM evaluated in the present study was not cost-effective compared to standard care. Based on these results, implementation of this exercise program for the prevention of GDM cannot be recommended.
Trial registration
NTR1139
doi:10.1186/1471-2393-12-64
PMCID: PMC3475114  PMID: 22762376
Cost-effectiveness; Pregnancy; Exercise
24.  Working on wellness (WOW): A worksite health promotion intervention programme 
BMC Public Health  2012;12:372.
Background
Insufficient PA has been shown to cluster with other CVD risk factors including insufficient fruit and vegetable intake, overweight, increased serum cholesterol concentrations and elevated blood pressure. This paper describes the development of Working on Wellness (WOW), a worksite intervention program incorporating motivational interviewing by wellness specialists, targeting employees at risk. In addition, we describe the evaluation the effectiveness of the intervention among employees at increased risk for cardiovascular disease.
Methods
The intervention mapping (IM) protocol was used in the planning and design of WOW. Focus group discussions and interviews with employees and managers identified the importance of addressing risk factors for CVD at the worksite. Based on the employees’ preference for individual counselling, and previous evidence of the effectiveness of this approach in the worksite setting, we decided to use motivational interviewing as part of the intervention strategy. Thus, as a cluster-randomised, controlled control trial, employees at increased risk for CVD (N = 928) will be assigned to a control or an intervention group, based on company random allocation. The sessions will include motivational interviewing techniques, comprised of two face-to-face and four telephonic sessions, with the primary aim to increase habitual levels of PA. Measures will take place at baseline, 6 and 12 months. Secondary outcomes include changes in nutritional habits, serum cholesterol and glucose concentrations, blood pressure and BMI. In addition, healthcare expenditure and absenteeism will be measured for the economic evaluation. Analysis of variance will be performed to determine whether there were significant changes in physical activity habits in the intervention and control groups at 6 and 12 months.
Discussion
The formative work on which this intervention is based suggests that the strategy of targeting employees at increased risk for CVD is preferred. Importantly, this study extends the work of a previous, similar study, Health Under Construction, in a different setting. Finally, this study will allow an economic evaluation of the intervention that will be an important outcome for health care funders, who ultimately will be responsible for implementation of such an intervention.
Trial registration
United States Clinical Trails Register NCT 01494207
doi:10.1186/1471-2458-12-372
PMCID: PMC3433314  PMID: 22625844
25.  Is the process of delivery of an individually tailored lifestyle intervention associated with improvements in LDL cholesterol and multiple lifestyle behaviours in people with Familial Hypercholesterolemia? 
BMC Public Health  2012;12:348.
Background
More insight in the association between reach, dose and fidelity of intervention components and effects is needed. In the current study, we aimed to evaluate reach, dose and fidelity of an individually tailored lifestyle intervention in people with Familial Hypercholesterolemia (FH) and the association between intervention dose and changes in LDL-Cholesterol (LDL-C), and multiple lifestyle behaviours at 12-months follow-up.
Methods
Participants (n = 181) randomly allocated to the intervention group received the PRO-FIT intervention consisting of computer-tailored lifestyle advice (PRO-FIT*advice) and counselling (face-to-face and telephone booster calls) using Motivational Interviewing (MI). According to a process evaluation plan, intervention reach, dose delivered and received, and MI fidelity were assessed using the recruitment database, website/counselling logs and the Motivational Interviewing Treatment Integrity (MITI 3.1.1.) code. Regression analyses were conducted to explore differences between participant and non-participant characteristics, and the association between intervention dose and change in LDL-C, and multiple lifestyle behaviours.
Results
A 34% (n = 181) representative proportion of the intended intervention group was reached during the recruitment phase; participants did not differ from non-participants (n = 623) on age, gender and LDL-C levels. Of the participants, 95% received a PRO-FIT*advice log on account, of which 49% actually logged on and completed at least one advice module. Nearly all participants received a face-to-face counselling session and on average, 4.2 telephone booster calls were delivered. None of the face-to-face sessions were implemented according to MI guidelines. Overall, weak non-significant positive associations were found between intervention dose and LDL-C and lifestyle behaviours.
Conclusions
Implementation of the PRO-FIT intervention in practice appears feasible, particularly PRO-FIT*advice, since it can be relative easily implemented with a high dose delivered. However, only less than half of the intervention group received the complete intervention-package as intended. Strategies to let participants optimally engage in using web-based computer-tailored interventions like PRO-FIT*advice are needed. Further, more emphasis should be put on more extensive MI training and monitoring/supervision.
Trial registration
NTR1899 at ww.trialregister.nl.
doi:10.1186/1471-2458-12-348
PMCID: PMC3487747  PMID: 22583789
Counselling; Computer tailoring; Cholesterol; Lifestyle behaviours; Dose; Fidelity; Motivational interviewing; Process evaluation; Efficacy

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