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1.  Healthy for Life: A Randomized Trial Examining Physical Activity Outcomes and Psychosocial Mediators 
Background
Researchers theorize that interventions increase physical activity by influencing key theory-based mediators (e.g., behavioral processes). However, few studies have been adequately powered to examine the importance of mediators.
Purpose
This study examined both physical activity behavior and psychosocial mediators in a randomized trial specifically powered to detect mediation.
Methods
Healthy, sedentary adults (n=448; 70% Caucasian, 87% women, mean age was 43) were randomly assigned to either a six-month print-based theory tailored physical activity intervention (n=224) or a six-month health/wellness contact control arm (n=224).
Results
The print intervention arm exhibited greater increases in physical activity than the control arm at six and 12 months (p<.05). Additionally, behavioral processes were found to be an important mediator of physical activity behavior.
Conclusions
It is important for researchers and practitioners to focus on increasing behavioral strategies for physical activity adoption. Future studies should examine other potential mediators of physical activity.
doi:10.1007/s12160-012-9439-5
PMCID: PMC3597765  PMID: 23229158
Exercise; Physical Activity; Mediators; Intervention Studies
2.  Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial – study protocol 
Background
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.
Methods/Design
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.
Discussion
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
NCT01679210
doi:10.1186/1471-2393-14-100
PMCID: PMC3975296  PMID: 24606590
Lifestyle intervention; Randomised controlled trial; Healthy eating; Prevention; Diet; Latina; Physical activity; Postpartum; Pregnancy; Gestational diabetes mellitus; Transtheoretical model
3.  Recruiting Young Adult Cancer Survivors for Behavioral Research 
Young adults have been dramatically underrepresented in cancer survivorship research. One contributing factor is the difficulty recruiting this population. To identify effective recruitment strategies, the current study assessed the yield of strategies used to recruit young survivors for an exercise intervention including: clinic-based recruitment, recruitment at cancer-related events, mailings, telephone-based recruitment, advertising on the internet, radio, television and social networking media, distributing brochures and word-of-mouth referrals. When taking into account the strategies for which we could track the number of survivors approached, recruitment at an oncology clinic was the most productive: 38 % of those approached were screened and 8 % enrolled. When evaluating which strategy yielded the greatest percentage of the sample, however, mailings were the most productive. Given widespread use of the internet and social networking by young adults, investigators should also consider these low-cost recruitment strategies.
doi:10.1007/s10880-012-9317-0
PMCID: PMC3541434  PMID: 22810954
Young adult; Cancer survivors; Recruitment; Internet
4.  Psychosocial Outcomes of an Exercise Maintenance Intervention After Phase II Cardiac Rehabilitation 
PURPOSE
Maintenance of exercise after completing Phase II cardiac rehabilitation (CR) is challenging for many patients. We offered a telephone-based maintenance intervention and found improvement in exercise participation in the intervention group at 12 months post-CR discharge. We examined the effects of the intervention on psychosocial outcomes.
METHODS
The effects of a home-based exercise maintenance intervention on psychosocial outcomes among patients who had completed Phase II CR vs. contact control was evaluated in a randomized controlled trial. Data were collected in 2005–2010 and analyzed in 2011. One hundred thirty patients (mean age=63.6 years [SD=9.7], 20.8% female) were randomized to exercise counseling (Maintenance Counseling group, n=64) or contact control (Contact Control group, n=66). Maintenance Counseling group participants received exercise counseling (based on the Transtheoretical Model and Social-Cognitive Theory) delivered via telephone for 6 months, as well as print materials and feedback reports. Assessments of depression, quality of life and mental health were conducted at baseline, 6, and 12 months.
RESULTS
The Maintenance Counseling group reported statistically significant higher quality of life than the Contact Control group at 6 (b=0.29, se=0.08, P<.001) and 12 months (b=0.27, se=0.09, P=.002). Intervention effects on depressive symptoms were significant at 12 months (b=−6.42, se=2.43, P=.009). Effects on overall mental health were nonsignificant at both followups. No significant moderators of treatment effects were found.
CONCLUSION
A telephone-based intervention that helped to maintain exercise showed statistically significant improvements in quality of life and reduced depressive symptoms in this patient population.
doi:10.1097/HCR.0b013e3182825531
PMCID: PMC3586302  PMID: 23422351
Exercise maintenance; cardiac rehabilitation; psychosocial outcomes
5.  A Pilot Study of a Physical Activity Intervention Targeted towards Women at Increased Risk for Breast Cancer 
Psycho-oncology  2011;22(2):381-387.
Objective
To pilot test a physical activity intervention targeted towards women with a first-degree relative with breast cancer.
Methods
Sedentary women (n=27) with at least 1 first-degree relative with breast cancer but no personal breast cancer diagnosis received a print-based physical activity intervention. The intervention was a 12-week theory-based and individually tailored physical activity intervention targeted towards women with a family history of breast cancer. Participants' minutes of physical activity, worry about breast cancer, perceived risk of developing breast cancer and perceived control over breast cancer risk were assessed at baseline and 12-weeks.
Results
There was a significant increase in minutes of moderate to vigorous intensity physical activity from baseline to 12 weeks (t=4.93, p<.001), with a mean increase in physical activity of 130.56 min/week (sd=137.50). At 12 weeks, 41% met ACSM criteria of engaging in 150 minutes or more of moderate intensity activity. Regression models indicate that change in perceived risk of breast cancer was significantly associated with change in physical activity (t=− 2.36, p=0.03, r=.34), with decreases in perceived risk associated with increases in physical activity over time.
Conclusions
Findings suggest that a targeted intervention can increase physical activity and decrease perceived risk of breast cancer.
doi:10.1002/pon.2101
PMCID: PMC3368094  PMID: 22135183
Physical activity; intervention; breast cancer risk; Cancer; Oncology
6.  Recruitment of veterans from primary care into a physical activity randomized controlled trial: the experience of the VA-STRIDE study 
Trials  2014;15:11.
Background
Much of the existing literature on physical activity (PA) interventions involves physically inactive individuals recruited from community settings rather than clinical practice settings. Recruitment of patients into interventions in clinical practice settings is difficult due to limited time available in the clinic, identification of appropriate personnel to efficiently conduct the process, and time-consuming methods of recruitment. The purpose of this report is to describe the approach used to identify and recruit veterans from the Veterans Affairs (VA) Pittsburgh Healthcare System Primary Care Clinic into a randomized controlled PA study.
Methods
A sampling frame of veterans was developed using the VA electronic medical record. During regularly scheduled clinic appointments, primary care providers (PCPs) screened identified patients for safety to engage in moderate-intensity PA and willingness to discuss the study with research staff members. Research staff determined eligibility with a subsequent telephone screening call and scheduled a research study appointment, at which time signed informed consent and baseline measurements were obtained.
Results
Of the 3,482 veterans in the sampling frame who were scheduled for a primary care appointment during the study period, 1,990 (57.2%) were seen in the clinic and screened by the PCP; moderate-intensity PA was deemed safe for 1,293 (37.1%), 871 (25.0%) agreed to be contacted for further screening, 334 (9.6%) were eligible for the study, and 232 (6.7%) enrolled.
Conclusions
Using a semiautomated screening approach that combined an electronically-derived sampling frame with paper and pencil prescreening by PCPs and research staff, VA-STRIDE was able to recruit 1 in 15 veterans in the sampling frame. Using this approach, a high proportion of potentially eligible veterans were screened by their PCPs.
Trial registration
Clinical trials.gov identifier: NCT00731094.
doi:10.1186/1745-6215-15-11
PMCID: PMC3923270  PMID: 24398076
Veterans; Primary care; Physical activity; Overweight; Randomized controlled trial
7.  Physical activity in Latinas: social and environmental influences 
Women's health (London, England)  2013;9(2):10.2217/whe.13.9.
Latinas are the largest, fastest growing female ethnic minority group in the USA, and also report the lowest levels of physical activity. Following the framework of the social ecological model, this review examines unique social and environmental factors that influence physical activity in Latinas. Research shows that Latinas receive little social support for activity despite having large, close-knit social networks. Interventions incorporating social support components are generally effcacious. Latinas also face many environmental barriers, including crime, heat, traffic, lack of facilities and a fear of immigration enforcement, and there have been few attempts to address environmental barriers in Latino communities. Successful future interventions will need to consider unique social and environmental barriers affecting Latinas, and help Latinas learn to incorporate social networks into physical activity participation.
doi:10.2217/whe.13.9
PMCID: PMC3868363  PMID: 23477325
environmental barriers; Latinas; physical activity; social ecological model; social support
8.  Colorado stride (COSTRIDE): testing genetic and physiological moderators of response to an intervention to increase physical activity 
Background
The purpose of this research was to replicate a successful intervention to increase physical activity in a different region of the country, and explore genetic and physiological moderators of intervention efficacy drawn from a transdisciplinary theoretical framework.
Method
A randomized controlled trial comparing a print-based physical activity intervention (COSTRIDE) to a print-based health and wellness contact control (HW) intervention was conducted. Sedentary participants (n = 219) completed assessments at baseline and follow-up assessments at 3, 6, 9, and 12 months following the initiation of the intervention.
Results
Participants in both conditions significantly increased exercise behavior in the first six months, and then leveled off or decreased physical activity in the second six months of the study. Those in the COSTRIDE intervention increased significantly more than those in the HW intervention, and were better able to maintain their exercise behavior. Genetic factors (BDNF, rs6265; FTO, rs8044769), but not selected physiological (body temperature, blood lactate, systolic blood pressure, plasma norepinephrine, and heart rate) or subjective (perceived pain, affect) responses to physical activity, moderated response to the intervention.
Conclusions
There are underlying genetic factors that influence response to behavioral intervention, and a better understanding of these factors has the potential to influence the development, targeting and tailoring of behavioral interventions to increase physical activity.
Trial registration
Clinicaltrials.gov registration: NCT01091857.
doi:10.1186/1479-5868-10-139
PMCID: PMC3880176  PMID: 24359456
Exercise; Physical activity; Intervention; Genetics; Transdisciplinary
10.  Developing an intervention to address physical activity barriers for African–American women in the deep south (USA) 
Women's health (London, England)  2013;9(3):10.2217/whe.13.20.
Aim
To address high rates of inactivity and related chronic diseases among African–American women.
Materials & methods
Eleven focus groups on physical activity barriers for African–American women in the deep south (USA) were conducted (n = 56). Feedback guided an intervention development process. The resulting Home-Based Individually Tailored Physical Activity Print intervention was vetted with the target population in a 1-month, single arm, pre–post test demonstration trial (n = 10).
Results
Retention was high (90%). Intent-to-treat analyses indicated increases in motivational readiness for physical activity (70% of sample) and physical activity (7-day Physical Activity Recall) from baseline (mean: 89.5 min/week, standard deviation: 61.17) to 1 month (mean: 155 min/week, standard deviation: 100.86). Small improvements in fitness (6-Min Walk Test), weight and psychosocial process measures were also found.
Conclusion
Preliminary findings show promise and call for future randomized controlled trials with larger samples to determine efficacy. Such low-cost, high-reach approaches to promoting physical activity have great potential for addressing health disparities and benefiting public health.
doi:10.2217/whe.13.20
PMCID: PMC3816507  PMID: 23638785
African–merican women; exercise; health disparity; physical activity
11.  Rationale, design, and baseline findings from Seamos Saludables: a randomized controlled trial testing the efficacy of a culturally and linguistically adapted, computer- tailored physical activity intervention for Latinas 
Contemporary clinical trials  2012;33(6):1261-1271.
Background
Latinos are now the largest (and fastest growing) ethnic minority group in the United States. Latinas report high rates of physical inactivity and suffer disproportionately from obesity, diabetes, and other conditions that are associated with sedentary lifestyles. Effective physical activity interventions are urgently needed to address these health disparities.
Method/Design
An ongoing randomized controlled trial will test the efficacy of a home-based, individually tailored physical activity print intervention for Latinas (1R01NR011295). This program was culturally and linguistically adapted for the target population through extensive formative research (6 focus groups, 25 cognitive interviews, iterative translation process). This participant feedback was used to inform intervention development. Then, 268 sedentary Latinas were randomly assigned to receive either the Tailored Intervention or the Wellness Contact Control arm. The intervention, based on Social Cognitive Theory and the Transtheoretical Model, consists of six months of regular mailings of motivation-matched physical activity manuals and tip sheets and individually tailored feedback reports generated by a computer expert system, followed by a tapered dose of mailings during the second six months (maintenance phase). The main outcome is change in minutes/week of physical activity at six months and one year as measured by the 7-Day Physical Activity Recall (7-Day PAR). To validate these findings, accelerometer data will be collected at the same time points.
Discussion
High reach, low cost, culturally relevant interventions to encourage physical activity among Latinas could help reduce health disparities and thus have a substantial positive impact on public health.
doi:10.1016/j.cct.2012.07.005
PMCID: PMC3468688  PMID: 22789455
physical activity; exercise; health disparities; Latinas; Hispanics
12.  Examination of a Telephone-Based Exercise Intervention for the Prevention of Postpartum Depression: Design, Methodology, and Baseline Data from The Healthy Mom Study 
Contemporary clinical trials  2012;33(6):1150-1158.
Research indicates that exercise is an efficacious intervention for depression among adults; however, little is known regarding its efficacy for preventing postpartum depression. The Healthy Mom study was a randomized controlled trial examining the efficacy of an exercise intervention for the prevention of postpartum depression. Specifically, postpartum women with a history of depression or a maternal family history of depression (n=130) were randomly assigned to a telephone-based exercise intervention or a wellness/support contact control condition each lasting six months. The exercise intervention was designed to motivate postpartum women to exercise based on Social Cognitive Theory and the Transtheoretical Model. The primary dependent variable was depression based on the Structured Clinical Diagnostic Interview (SCID). Secondary dependent variables included scores on the Edinburgh Postnatal Depression Scale, the PHQ-9, and the Perceived Stress Scale. The purpose of this paper is to describe the study design, methodology, and baseline data for this trial. Upon completion of the trial, the results will yield important information about the efficacy of exercise in preventing postpartum depression.
doi:10.1016/j.cct.2012.07.015
PMCID: PMC3468699  PMID: 22890220
Exercise; physical activity; postpartum depression; prevention; intervention; stress
13.  Determining who responds better to a computer- vs. human-delivered physical activity intervention: results from the community health advice by telephone (CHAT) trial 
Background
Little research has explored who responds better to an automated vs. human advisor for health behaviors in general, and for physical activity (PA) promotion in particular. The purpose of this study was to explore baseline factors (i.e., demographics, motivation, interpersonal style, and external resources) that moderate intervention efficacy delivered by either a human or automated advisor.
Methods
Data were from the CHAT Trial, a 12-month randomized controlled trial to increase PA among underactive older adults (full trial N = 218) via a human advisor or automated interactive voice response advisor. Trial results indicated significant increases in PA in both interventions by 12 months that were maintained at 18-months. Regression was used to explore moderation of the two interventions.
Results
Results indicated amotivation (i.e., lack of intent in PA) moderated 12-month PA (d = 0.55, p < 0.01) and private self-consciousness (i.e., tendency to attune to one’s own inner thoughts and emotions) moderated 18-month PA (d = 0.34, p < 0.05) but a variety of other factors (e.g., demographics) did not (p > 0.12).
Conclusions
Results provide preliminary evidence for generating hypotheses about pathways for supporting later clinical decision-making with regard to the use of either human- vs. computer-delivered interventions for PA promotion.
doi:10.1186/1479-5868-10-109
PMCID: PMC3849440  PMID: 24053756
Physical activity; Intervention; Moderation; Interactive voice response; Behavioral intervention technology system; Targeting
14.  The challenges of translating an efficacious smoking cessation program, Commit to Quit, to the community setting of YMCAs 
Commit to Quit (CTQ), a program that utilized vigorous intensity exercise as an adjunct to a cognitive-behavioral smoking cessation program, was shown to be effective for female smokers (Marcus et al., Prev Med 26(4):586–597, 1997; Marcus et al., Arch Intern Med 159(11):1229–1234, 1999). Adapting effective programs, such as CTQ, to community settings could lead to a large public health impact as the program could substantially increase its reach. This case study chronicles the steps taken by researchers to translate CTQ from the medical to the community setting of YMCAs (CTQY). Use of aspects of Diffusion Theory [3] such as identifying a champion of the program and attending to the characteristics of an innovation to enhance program adoption are discussed. Details regarding attending to the tensions between internal and external validity as the program was adapted to the community setting are also outlined. The challenges of conducting community trials are discussed.
doi:10.1007/s13142-012-0181-0
PMCID: PMC3717995  PMID: 24073160
Translation; Smoking cessation; Physical activity; Community setting; Diffusion Theory
15.  Yoga as a Complementary Treatment for Smoking Cessation in Women 
Journal of Women's Health  2012;21(2):240-248.
Abstract
Background
Tobacco smoking remains the leading preventable cause of death among American women. Aerobic exercise has shown promise as an aid to smoking cessation because it improves affect and reduces nicotine withdrawal symptoms. Studies outside the realm of smoking cessation have shown that yoga practice also reduces perceived stress and negative affect.
Methods
This pilot study examines the feasibility and initial efficacy of yoga as a complementary therapy for smoking cessation. Fifty-five women were given 8-week group-based cognitive behavioral therapy for smoking cessation and were randomized to a twice-weekly program of Vinyasa yoga or a general health and wellness program (contact control). The primary outcome measure was 7-day point prevalence abstinence at the end of treatment validated by saliva cotinine testing. Longitudinal analyses were also conducted to examine the effect of intervention on smoking cessation at 3- and 6-month follow-up. We examined the effects of the intervention on potential mediating variables (e.g., confidence in quitting smoking, self-efficacy), as well as measures of depressive symptoms, anxiety, and perceived health (SF-36).
Results
At end of treatment, women in the yoga group had a greater 7-day point-prevalence abstinence rate than controls (odds ratio [OR], 4.56; 95% CI, 1.1–18.6). Abstinence remained higher among yoga participants through the six month assessment (OR, 1.54; 95% CI, 0.34–6.92), although differences were no longer statistically significant. Women participating in the yoga program also showed reduced anxiety and improvements in perceived health and well-being when compared with controls.
Conclusions
Yoga may be an efficacious complementary therapy for smoking cessation among women.
doi:10.1089/jwh.2011.2963
PMCID: PMC3304243  PMID: 21992583
16.  Internet-Based Physical Activity Intervention Targeting Young Adult Cancer Survivors 
Purpose: Young adults who have been treated for cancer face several health and psychosocial risks. To minimize these risks, is it imperative that they address any modifiable risk factors, such as sedentary lifestyle. Unfortunately, more than half of young adult cancer survivors remain sedentary. To facilitate the adoption of physical activity (PA) in this population—potentially reducing health and psychosocial risks—we developed and pilot tested an internet-based PA intervention for young survivors. Patients and methods: Eighteen young adults, aged 18 to 39, who had been diagnosed with cancer in the past 10 years were recruited. Participants were randomized to receive access to the PA website for 12 weeks or information about other cancer-related websites. Intervention feasibility and acceptability was assessed only among those in the PA website group; PA and psychosocial outcomes (mood, fatigue) were assessed in both groups. Results: Findings revealed that 86% of participants in the PA website group would recommend the intervention to others and most (71%) were “satisfied” or “very satisfied” with it. Further, 100% rated getting onto the website as “very easy” and 86% rated the information on the site as “very easy” to understand. The logging feature, followed by the goal-setting feature, were most often accessed by participants. Participants also rated the graphing and stage-matched manual features as helpful. Estimates of effect sizes for between-group differences at 12 weeks were medium for PA outcomes and large for psychosocial outcomes. Conclusions: This internet-based PA intervention targeting young adult cancer survivors is feasible and acceptable and may benefit this population.
doi:10.1089/jayao.2011.0040
PMCID: PMC3623566  PMID: 23610737
survivorship; physical activity; exercise; internet
17.  The efficacy of vigorous-intensity exercise as an aid to smoking cessation in adults with elevated anxiety sensitivity: study protocol for a randomized controlled trial 
Trials  2012;13:207.
Background
Although cigarette smoking is a leading cause of death and disability in the United States (US), over 40 million adults in the US currently smoke. Quitting smoking is particularly difficult for smokers with certain types of psychological vulnerability. Researchers have frequently called attention to the relation between smoking and anxiety-related states and disorders, and evidence suggests that panic and related anxiety vulnerability factors, specifically anxiety sensitivity (AS or fear of somatic arousal), negatively impact cessation. Accordingly, there is merit to targeting AS among smokers to improve cessation outcome. Aerobic exercise has emerged as a promising aid for smoking cessation for this high-risk (for relapse) group because exercise can effectively reduce AS and other factors predicting smoking relapse (for example, withdrawal, depressed mood, anxiety), and it has shown initial efficacy for smoking cessation. The current manuscript presents the rationale, study design and procedures, and design considerations of the Smoking Termination Enhancement Project (STEP).
Methods
STEP is a randomized clinical trial that compares a vigorous-intensity exercise intervention to a health and wellness education intervention as an aid for smoking cessation in adults with elevated AS. One hundred and fifty eligible participants will receive standard treatment (ST) for smoking cessation that includes cognitive behavioral therapy (CBT) and nicotine replacement therapy (NRT). In addition, participants will be randomly assigned to either an exercise intervention (ST+EX) or a health and wellness education intervention (ST+CTRL). Participants in both arms will meet 3 times a week for 15 weeks, receiving CBT once a week for the first 7 weeks, and 3 supervised exercise or health and wellness education sessions (depending on randomization) per week for the full 15-week intervention. Participants will be asked to set a quit date for 6 weeks after the baseline visit, and smoking cessation outcomes as well as putative mediator variables will be measured up to 6 months following the quit date.
Discussion
The primary objective of STEP is to evaluate whether vigorous-intensity exercise can aid smoking cessation in anxiety vulnerable adults. If effective, the use of vigorous-intensity exercise as a component of smoking cessation interventions would have a significant public health impact. Specifically, in addition to improving smoking cessation treatment outcome, exercise is expected to offer benefits to overall health, which may be particularly important for smokers. The study is also designed to test putative mediators of the intervention effects and therefore has the potential to advance the understanding of exercise-anxiety-smoking relations and guide future research on this topic.
Clinical trials registry
ClinicalTrials.gov, NCT01065506, http://clinicaltrials.gov/ct2/show/NCT01065506
doi:10.1186/1745-6215-13-207
PMCID: PMC3522063  PMID: 23148822
Smoking; Smoking cessation; Intervention; Randomized controlled trial; Exercise; Aerobic exercise; Anxiety; Anxiety sensitivity
18.  Physical activity as an aid to smoking cessation during pregnancy (LEAP) trial: study protocol for a randomized controlled trial 
Trials  2012;13:186.
Background
Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP) trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date.
Methods/design
The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy), and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation) or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations). The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome.
Discussion
This trial will assess whether a PA intervention is effective when used for smoking cessation during pregnancy.
Trial registration
ISRCTN48600346
doi:10.1186/1745-6215-13-186
PMCID: PMC3519528  PMID: 23035669
Smoking cessation; Pregnancy; Physical activity; Intervention; Randomized controlled trial
19.  Maintenance of Exercise After Phase II Cardiac Rehabilitation 
Background
Patients who have completed Phase II cardiac rehabilitation have low rates of maintenance of exercise after program completion, despite the importance of sustaining regular exercise to prevent future cardiac events.
Purpose
The efficacy of a home-based intervention to support exercise maintenance among patients who had completed Phase II cardiac rehabilitation versus contact control was evaluated.
Design
An RCT was used to evaluate the intervention. Data were collected in 2005–2010 and analyzed in 2010.
Setting/participants
One hundred and thirty patients (mean age = 63.6 years [SD=9.7], 20.8% female) were randomized to exercise counseling (Maintenance Counseling group, n=64) or contact control (Contact Control group, n=66).
Intervention
Maintenance Counseling group participants received a 6-month program of exercise counseling (based on the Transtheoretical Model and Social–Cognitive Theory) delivered via telephone, as well as print materials and feedback reports.
Main outcome measures
Assessments of physical activity (7-Day PAR), motivational readiness for exercise, lipids and physical functioning were conducted at baseline, 6 and 12 months. Objective accelerometer data were collected at the same time-points. Fitness was assessed via maximal exercise stress tests at baseline and 6 months.
Results
The Maintenance Counseling group reported significantly higher exercise participation than the Contact Control group at 12 months (difference of 80 minutes, 95% CI 22,137). Group differences in exercise at 6 months were nonsignificant. The intervention significantly increased the probability of participants’ exercising at or above physical activity guidelines and attenuated regression in motivational readiness versus the Contact Control Group at 6 and 12 months. Self-reported physical functioning was significantly higher in the Maintenance Counseling group at 12 months. No group differences were seen in fitness at 6 months or lipid measures at 6 and 12 months.
Conclusions
A telephone-based intervention can help maintain exercise, prevent regression in motivational readiness for exercise and improve physical functioning in this patient population.
doi:10.1016/j.amepre.2011.04.015
PMCID: PMC3160619  PMID: 21855741
20.  Resistance Training as an Aid to Standard Smoking Cessation Treatment: A Pilot Study 
Nicotine & Tobacco Research  2011;13(8):756-760.
Introduction:
Research indicates that exercise may be helpful for smoking cessation; however, the majority of studies have focused only on women and only on aerobic exercise. This pilot study explored the use of resistance training (RT) (i.e., weight lifting) as an adjunctive strategy for quitting smoking for both men and women.
Methods:
A sample of 25 smokers received a brief smoking cessation counseling session and the nicotine patch prior to being randomized into a 12-week RT or contact control (CC) group. Assessments were conducted at baseline, 3-month, and at a 6-month follow-up.
Results:
Participants (52% female) averaged 36.5 years (SD = 12.0) of age and 19.1 years (SD = 12.0) of smoking. At the 3-month assessment, objectively verified 7-day point prevalence abstinence (PPA) rates were 46% for the RT group and 17% for CC; prolonged abstinence rates were 16% and 8%, respectively. At the 6-month assessment, objectively verified 7-day PPA rates were 38% for the RT group and 17% for CC; prolonged abstinence rates were 15% and 8%, respectively. Mean body weight decreased 0.6 kg (SD = 1.7) in the RT group and increased 0.6 kg (SD = 2.8) in the CC group. Mean body fat decreased 0.5% (SD = 1.8) in the RT group and increased 0.6% (SD = 0.7) in the CC.
Conclusions:
This is the first study reporting on the use of a RT program as an aid to smoking cessation treatment. The findings suggest that such a program is feasible as an adjunctive treatment for smoking cessation. An adequately powered trial is warranted.
doi:10.1093/ntr/ntr068
PMCID: PMC3150692  PMID: 21504883
21.  The Big Picture of Individual Differences in Physical Activity Behavior Change: A Transdisciplinary Approach 
The goal of this research is to utilize a transdisciplinary framework to guide the selection of putative moderators of the effectiveness of an intervention to promote physical activity behavior adoption and maintenance in the context of a randomized controlled intervention trial. Effective interventions to increase physical activity are sorely needed, and one barrier to the identification and development of such interventions is the lack of research targeted at understanding both the mechanisms of intervention efficacy and for whom particular interventions are effective. The purpose of this paper is to outline our transdisciplinary approach to understanding individual differences in the effectiveness of a previously successful exercise promotion intervention. We explain the rationale for and operationalization of our framework, characteristics of the study to which we apply the framework, and planned analyses. By embracing a transdisciplinary orientation for individual differences important in the prediction of physical activity (spanning molecular approaches, animal models, human laboratory models, and social psychological models), we hope to have a better understanding of characteristics of individuals that are important in the adoption and maintenance of physical activity.
doi:10.1016/j.psychsport.2010.05.002
PMCID: PMC3026580  PMID: 21278837
Physical Activity; Exercise; Transdisciplinary; Genetic; COSTRIDE; Affect; Motivation
22.  Impact of Baseline BMI upon the Success of Latina Participants Enrolled in a 6-Month Physical Activity Intervention 
Journal of Obesity  2011;2011:921916.
High rates of obesity in Latinas highlight the need to determine if physical activity interventions are equally effective across the body mass index (BMI) range. Thus, this study assessed how BMI impacts success of Spanish-speaking Latinas in a culturally and linguistically adapted theory-based physical activity intervention (N = 45). Longitudinal regression models tested the relationship between baseline BMI and outcomes. Overall, a trend for a negative association was found between baseline BMI and self-reported physical activity and theoretical constructs targeted by the intervention over time. For example, someone with a 25 kg/m2 BMI would report, on average, 27.5 more minutes/week of activity compared to someone with a 30 kg/m2 BMI at followup. Furthermore, higher baseline BMI was significantly associated with lower self-efficacy, behavioral and cognitive processes of change, and family social support over time. These findings suggest that participants with higher BMI may need additional intervention to promote physical activity.
doi:10.1155/2011/921916
PMCID: PMC3228324  PMID: 22175003
23.  Accelerometer Use in a Physical Activity Intervention Trial 
Contemporary clinical trials  2010;31(6):514-523.
This paper describes the application of best practice recommendations for using accelerometers in a physical activity (PA) intervention trial, and the concordance of different methods for measuring PA. A subsample (n=63; 26%) of the 239 healthy, sedentary adults participating in a PA trial (mean age=47.5; 82% women) wore the ActiGraph monitor at all 3 assessment time points. ActiGraph data were compared with self-report (i.e., PA weekly recall and monthly log) and fitness variables. Correlations between the PA recall and ActiGraph for moderate intensity activity ranged from 0.16–0.48 and from 0.28–0.42 for vigorous intensity activity. ActiGraph and fitness [estimated VO2(ml/kg/min)] had correlations of 0.15–0.45. The ActiGraph and weekly self-report were significantly correlated at all time points (correlations ranged from 0.23–0.44). In terms of detecting intervention effects, intervention groups recorded more minutes of at least moderate-intensity PA on the ActiGraph than the control group at 6 months (min=46.47, 95% CI=14.36–78.58), but not at 12 months. Limitations of the study include a small sample size and only 3 days of ActiGraph monitoring. To obtain optimal results with accelerometers in clinical trials, the authors recommend following best practice recommendations: detailed protocols for monitor use, calibration of monitors and validation of data quality, and use of validated equations for analysis. The ActiGraph has modest concordance with other assessment tools and is sensitive to change over time. However, until more information validating the use of accelerometry in clinical trials becomes available, properly administered self-report measures of PA should remain part of the assessment battery.
doi:10.1016/j.cct.2010.08.004
PMCID: PMC2956863  PMID: 20723619
exercise; objective monitoring; best practice recommendations; ActiGraph
24.  Stimulant Reduction Intervention using Dosed Exercise (STRIDE) - CTN 0037: Study protocol for a randomized controlled trial 
Trials  2011;12:206.
Background
There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study.
Methods/Design
STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI) or Health Education Intervention Augmentation (HEI). Both groups will receive TAU (i.e., usual care). The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions, although other participants may be exercising at the same time. Following the 12-week acute phase, participants will begin a 6-month continuation phase during which time they will attend one weekly supervised DEI or HEI session.
Clinical Trials Registry
ClinicalTrials.gov, NCT01141608
http://clinicaltrials.gov/ct2/show/NCT01141608?term=Stimulant+Reduction+Intervention+using+Dosed+Exercise&rank=1
doi:10.1186/1745-6215-12-206
PMCID: PMC3191354  PMID: 21929768
stimulant abuse; stimulant dependence; exercise; health education; behavioral intervention
25.  Randomized controlled trial of computerized tailored physical activity reports 
Background
Computerized, tailored interventions have the potential to be a cost-effective means to assist a wide variety of individuals with behavior change. To examine the effect of computerized tailored physical activity reports on primary care patients' physical activity at six months.
Design
Two-group randomized clinical trial with primary care physicians as the unit of randomization. Patients were placed in the intervention (n=187) or control group (n=207) based on their physician's assignment.
Setting/Participants
Primary care physicians (n=22) and their adult patients (n=394) from Philadelphia, PA. The study and analyses were conducted from 2004-2010.
Intervention
The intervention group completed physical activity surveys at baseline, one, three, and six months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to the participant's needs; they also included an activity prescription. The control group received identical procedures except they received general reports on preventive screening based on their responses to preventive screening questions.
Main outcome measure
Minutes of physical activity measured by the 7-Day Physical Activity Recall interview at six months.
Results
Participants were 69% female, 59% African American, and had diverse educational and income levels; the retention rate was 89.6%. After adjusting for baseline levels of activity and gender, the intervention group increased their total minutes of physical activity by a mean of 133 minutes, while the control group had a mean increase of 99 minutes (p=0.39).
Conclusions
Although we saw an increase in physical activity within both groups, computerized tailored physical activity reports did not significantly increase physical activity levels beyond control among ethnically and socioeconomically diverse adults in primary care.
doi:10.1016/j.amepre.2010.04.005
PMCID: PMC3140844  PMID: 20621262
primary care issues; physical activity; behavioral medicine; randomized clinical trial

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