Integrating health education and physical activity programming for ...

Contemporary Clinical Trials 48 (2016) 65–69

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Integrating health education and physical activity programming for cardiovascular health promotion among female inmates: A proof of concept study☆,☆☆,★ Uma S. Nair a,b,⁎, Jeremy S. Jordan c,1, Daniel Funk c,1, Kristin Gavin d, Erica Tibbetts d,e, Bradley N. Collins a,⁎⁎ a

Department of Social and Behavioral Sciences, College of Public Health, Temple University, 1301 Cecil B. Moore Avenue, Ritter Annex, 9th floor, Philadelphia, PA 19122, USA Mel and Enid Zuckerman College of Public Health, University of Arizona, Abrams Public Health Center, 3950 S Country Club Rd, STE 300, Tucson, AZ 85714, USA c Fox School of Business, Temple University, 1810 Liacouras Walk, Alter Hall, Philadelphia, PA 19122, USA d Gearing Up, Inc., 1221 Locust Street, Philadelphia, PA 19107, USA e Department of Kinesiology, College of Public Health, Temple University, 1800 N. Broad Street, 230 Pearson Hall, Philadelphia, PA 19122, USA b

a r t i c l e

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Article history: Received 3 November 2015 Received in revised form 11 March 2016 Accepted 21 March 2016 Available online 26 March 2016 Keywords: Physical activity Cardiovascular health Multiple health behavior change Underserved women

a b s t r a c t Female inmate populations in the United States tend to be overweight, physically inactive, experience high stress, and have a history of nicotine and other drug dependence. Thus, they bear an elevated risk of cardiovascular (CV) disease than the general population. However, few evidence-based health interventions exist for this population. This study will test proof of concept, feasibility, and potential efficacy of a multiple health behavior change intervention that integrates CV-health promotion education delivered during a physical activity (PA) program (indoor cycling) tailored to this population. This study uses a quasi-experimental 2-group design with two measurement time-points: baseline and 8-week end of treatment. N = 120 incarcerated women (18–59 years of age) who are medically cleared for participation in PA will be enrolled. Indoor cycling instructors will be trained to deliver five health education topics over an 8-week period during twice-weekly cycling classes. Topics match the American Heart Association recommendations for CV health: (a) nutrition, (b) PA promotion, (c) weight management, (d) stress management, and (e) smoking cessation and relapse prevention. Modes of intervention include instructor advice, written materials and audio/video clips reviewed during class. CV-related and mental health measures will be assessed at both time-points. Results will guide a full scale efficacy study. Future research in this area has potential to impact the health of female inmates, a high-risk population. Moreover, this multiple health behavior change intervention model represents a community approach to health promotion that could generalize to other underserved populations who may benefit most from similar intervention efforts. © 2016 Elsevier Inc. All rights reserved.

1. Introduction Cardiovascular (CV) disease is the leading cause of morbidity and mortality among women in the United States [1,2]. The combined prevalence of traditional CV disease risk factors related to unhealthy lifestyles (e.g., unhealthy weight and lack of recommended levels of ☆ Actual or potential conflict of interest: none. ☆☆ Funding source: Study was made possible through funding from the Edna G. Kynett Memorial Foundation through a sub-contract to Collins and Nair (Multi-PIs). ★ Financial support: the funding source has not been involved in the development of study or analyses of study results. ⁎ Correspondence to: U.S. Nair, Department of Social and Behavioral Sciences, College of Public Health, Temple University, 1301 Cecil B. Moore Avenue, Ritter Annex, 9th floor, Philadelphia, PA 19122, USA. ⁎⁎ Corresponding author. E-mail addresses: [email protected] (U.S. Nair), [email protected] (B.N. Collins). 1 School of Tourism & Hospitality Management, Temple University, 1810 N. 13th St, Speakman Hall, Philadelphia, PA 19122.

http://dx.doi.org/10.1016/j.cct.2016.03.007 1551-7144/© 2016 Elsevier Inc. All rights reserved.

physical activity [PA]) continues to remain high among all American women [2] and is a particular concern among low-income, underserved populations [3]. Efforts to address CV-related health disparities have been inadequate in yielding reductions in CV-related death and disease in this high-risk group [4]. Incarcerated women are a particularly vulnerable group facing poor CV-health outcomes. Many are low-income, overweight, maintain unhealthy behaviors (e.g., smoking, unhealthy diet, physical inactivity), have reduced access to health care prior to incarceration and experience high degrees of stress in their life [5,6]. Moreover, prison life elevates stress and limits opportunities for adequate stress management strategies that could mitigate stress-related physical and mental health consequences [7]. Thus, an unhealthy lifestyle history coupled with environmental and interpersonal stress contributes to overall increased CV risk and developing health behavior interventions for this underserved high-risk population needs to be an important public health area. Despite some preliminary evidence of the benefits of health intervention programs for incarcerated women in correctional facilities

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[8–10], there is a distinct dearth of recent and systematic, evidencebased programs. Implementing such health programs within prison systems would be an innovative mode of health care promotion and delivery for reaching this disadvantaged group. Prisons can be important sites of intervention for vulnerable populations who may be out of reach of conventional community-based health systems [11] and may serve as an opportunity for health care counseling, and treatment that inmates would not have otherwise received in the general community [12]. Moreover, well-designed prison-based health promotion interventions and education programs could allow for continuity of care between incarceration and transition back into the community for women who have little-to-no access to health care. To date, we are not aware of any study that has examined the feasibility of a CV health intervention for female inmates. Ours is a proof of concept study designed to examine the feasibility, acceptability, and preliminary efficacy of a multiple health behavior change intervention that integrates a PA program (indoor cycling) with CV health education for female inmates. If proof of concept goals is achieved, our intervention could serve as a model of behavioral health promotion for women in correctional facilities.

University. Rolling enrollment procedures will be used and interested women will meet with research staff to complete informed consent. After consent, intervention participants will complete baseline assessments and will receive five topical manuals relevant to CV health: nutrition, PA and importance of PA for a healthy lifestyle, weight management, stress management, smoking relapse prevention and staying smoke-free post-release. The control group will be consented but will not receive any health intervention materials. Compensation will be provided for completing baseline and 8-week (post intervention) assessment ($5 for each assessment will be deposited in their commissary account). 2.3. Participants We plan to recruit N = 120 incarcerated women into the study. The target population includes overweight and physically inactive women with a history of polysubstance dependence. Eligibility criteria include being between 18 and 59 years of age, medically cleared to participate in moderate intensity PA, and an anticipated prison stay for at least 5 months at the time of the informed consent (to minimize risk of attrition due to transfer or release).

2. Methods 2.4. Procedures 2.1. Study design and overview The study intervention focuses on improving CV health among female prison inmates by emphasizing five key areas outlined by the American Heart Association's ‘Life's Simple 7’ initiative [13] for optimal heart health. The intervention uses indoor cycling to focus program efforts on increasing weekly PA, a primary modifiable protective factor of CV health risks. Simultaneously, indoor cycling instructors deliver standardized health education modules designed to teach attendees about (a) the importance of maintaining healthy weight, (b) need for routine PA for CV health and stress management, (c) smoking cessation and maintaining a smoke-free lifestyle, (d) stress management, and (e) nutrition education. This study was developed through collaboration with Gearing Up, a nonprofit organization providing women in prison and those in transition (incarceration, abuse, or addiction) with skills and equipment to safely ride bicycles for exercise and personal growth (http://www.gearing-up.org). Our collaboration with Gearing Up complements their existing indoor cycling program through integration of health education components and provides a unique opportunity for assessing the impact of our novel health education intervention on a high-risk, low-income, underserved population.

Interested participants who are cleared to engage in PA and have the prison warden's approval to participate in the intervention will meet with study staff to complete informed consent procedures at the prison's medical facility. After signed consent is obtained, trained research staff will collect baseline assessments of self-report, anthropometric, and CV-health related measures. Intervention participants will begin participation in the IC + HEP intervention (see description below) with the goal of attending two out of the three weekly indoor cycling classes. Control participants will not attend the cycling sessions. If any of the control group participants express an interest in participating in the cycling session, they will be required to wait after completion to the 8-week post intervention assessment before attending the cycling sessions. All participants will meet with the research staff to complete follow-up assessments at the prison's medical facility. 2.5. Intervention The IC + HEP intervention expands the existing Gearing Up indoor cycling program by integrating critical CV health information that promotes fitness, healthy eating and weight maintenance, smoking cessation and relapse, and overall healthy lifestyle choices.

2.2. Aims and hypotheses Our primary aim is to test the effects of a health promotion intervention that integrates indoor cycling with a health education program (IC + HEP) on improving CV-health compared to a no-treatment control group. Additionally, as a secondary outcome, we will also explore the effects of our IC + HEP intervention on mental health (self-esteem and body-image). Our specific aims were defined around research questions related to health outcomes of interest as well as potential correlates of intervention effects. Results guided by these hypothesis tests will inform intervention work in this area. The study uses a quasi-experimental, two-group design (experimental vs. control) with two measurement periods: baseline and 8week post intervention. All women will be medically cleared for participation in PA. The control group will consist of women who are medically cleared for the study but not interested in participating in the intervention. We chose not to employ randomization due to inability to avoid cross group contamination. CV-related health changes are our primary outcome and mental health related changes are a secondary outcome. The study design and assessments are approved by the institutional review boards of the City of Philadelphia and Temple

2.5.1. Indoor group cycling (IC) The cycling component of the intervention follows the same core components, scheduling, and structure that the Gearing Up staff has provided to over 200 inmates at the facility since 2011. Indoor cycling classes (60 min sessions) will be led by trained instructors and held three times a week at the prison facility. 2.5.2. Health education program (HEP) The cycling instructors will be to deliver the health education program by the study's principal investigators (Collins and Nair). Training consists of 2-h workshops using didactic lectures, discussions, roleplaying, and readings on each of the health education modules. Instructors will also receive weekly supervision to review specific cases, problem solve participant issues that may come up during sessions, and ensure adherence to treatment protocols so as to maintain intervention integrity. During the intervention sessions, coaches will integrate indoor cycling with brief health education presentations (either verbally or via audio/video clips) and lead discussions that highlight points covered in their treatment manual. Designed specifically for this study by the

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principal investigators in collaboration with Gearing Up, the manual covers topics recommended by the American Heart Association [13], for CV health but the content will be tailored to address specific challenges of prison life and post-incarceration transition. Intervention feasibility will be assured through following the same cycling structure used by the Gearing Up staff since 2011. Each health education topic is delivered via multiple modes. First, participants will receive five separate manuals on topics outlined in Table 1, that emphasize important health education and behavior change strategies. Second, key points from each topic will be presented to participants across multiple sessions, delivered either by the cycling instructor directly or via audio/video clip at the end of a one-hour indoor cycling class. The schedule of topics is organized to provide repetition and to maximize the chance that all participants receive at least one discussion per each of the health topics during the 8-week intervention period. The intervention consists of evidence-based strategies to promote health behavior change including health education, providing social support, and positive reinforcement to guide changes to promote healthy behaviors (e.g., attending the cycling classes, making healthy eating choices). The five topics delivered over 8 weeks are (a) nutrition: women will learn about healthy serving sizes and what constitutes a healthy plate and includes information on tips for making healthy diet choices in the prison system, and on a budget post-release, education around reading food labels and limiting intake of foods high in fat, oils, and cholesterol and making alternative choices post-release. (b) PA: women will be educated on benefits of being physically active and health hazards of being inactive with strategies to be physically active both in the prison and post-release, (c) Weight management: this module will include education around importance of maintaining a healthy weight and information on how to maintain a healthy weight (e.g., keeping track of what you eat, what's a serving size, keeping portion sizes small). (d) Stress management: participants will be taught basic stress management techniques (e.g., focusing on positive selftalk, relaxation techniques) and using PA to manage negative moods and stress as opposed to alternatives, such as substance use, to maintain a drug-free, healthy CV lifestyle post-release (e) Smoking relapse prevention: this section will emphasize smoking cessation and relapse prevention as an essential component of ongoing CV health. Topics include the benefits of a smoke-free lifestyle post-release for women and their children (secondhand smoke exposure prevention) and short and long-term benefits of maintaining abstinence for CV health, healthy stress management, and ongoing PA. The weekly outline of the sessions and content covered are presented in Table 1. 3. Measures Participant data is collected in the medical clinic at the prison site. All measures are assessed at baseline and 8-week end of treatment.

3.1. Primary outcome measures CV-health related measures: (1) aerobic fitness will be assessed using the Canadian home fitness step test [14], (2) muscle flexibility will be measured by the Sit and Reach test [15], (3) body mass index will be measured using self-reported height and weight (kg/m2) and (4) percent body fat as measured by the Omron™ hand-held device.

3.2. Secondary outcome measures Mental health measures: (1) stress coping will be measured using the Rhode Island Stress and Coping Inventory (RISCI) [16], (b) selfesteem will be assessed using the Rosenberg Self-Esteem Scale [17], and (3) body image will be assessed using the Body Image States Scale [18].

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Table 1 Outline of the five key topics covered in the IC + HEP intervention group. Week

Mode of delivery

Week 1

Health education Physical activity − Overall benefits of cycling/PA − Recommendations of daily PA − Basic care during exercise/PA

Key topic and overview of content covered

Week 2

Health education Nutrition − Liquid calories − Health benefits of fruit and vegetable consumption − What is a healthy plate?

Week 3

Videos

Week 4

Health education Smoking − Using cycling/PA to manage nicotine withdrawal − Cycling/PA to manage post cessation weight gain − Cycling/PA to remain smoke-free and sober

Week 5

Health education Stress management − Natural vs. chronic stress − Symptoms of chronic stress − Healthy stress coping strategies

Week 6

Videos

Week 7

Health education Weight management − Importance of weight management − Maintaining healthy weight − Healthy weight management strategies

Week 8

Videos

Physical activity & nutrition − Guidelines for PA recommendations − How to get daily PA recommendations − Healthy eating: eating on a budget, reading labels

Smoking & stress management − Benefits of staying smokefree − Progressive muscle relaxation − Big tobacco and marketing strategies

Weight management − BMI: what is BMI? − Avoiding liquid calories − Practicing portion control

3.3. Correlates and non-program covariates We are not hypothesizing specific mediators and moderators as this is a proof of concept study and it lacks the sample size that would allow for analyses to test for complete mediation and moderation. However, we will explore correlates of intervention effects that could guide hypothesis generation and provide pilot data for a larger scale efficacy trial. Three variables will be measured as correlates or potential mediators of intervention effects: (a) cognitive factors as measured by general, goal-oriented self-efficacy [19] and enjoyment in the PA program [20], (b) social support as measured by social connectedness experienced in the PA program and (c) program adherence measured by number of cycling sessions attended during the 8-week intervention. Potential moderators include baseline demographic factors (age, race, and education) and a history of previous substance abuse.

4. Analytic plan The primary analyses will use an intention-to-treat approach [21, 22]. Missing outcome data will be addressed using multiple imputation methods. In sensitivity analyses, we will perform complete case analyses to investigate the impact of data that is potentially not missing at random. Descriptive statistics will be generated for the total sample and groups for each time point. Analysis of distributional properties will be performed to determine if variance stabilizing or normalizing transformations should be applied. Outliers will be assessed via visual

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inspection of distributions and checked for accuracy. Preliminary analyses will include univariate tests of association between demographics and outcomes, with variables demonstrating associations with p b .10 included in subsequent primary multivariate analyses described below. Aim 1: CV-health related outcomes will be modeled for intervention effects using linear mixed effects modeling [23]. Variables in which there are significant between-group differences in preliminary analyses will be used as control variables in longitudinal modeling. Separate models will be generated for each outcome, with outcome regressed on intervention group along with any other covariates identified in preliminary analyses. Differences in outcome over time will be examined via inferential testing of the “intervention-by-time” interaction term. Restricted maximum likelihood estimation will be used, and an appropriate covariance matrix will be specified. Linear and quadratic mixed models will be examined. The mechanism for missingness will be evaluated for any missing data at follow-up. Aim 2: to test intervention effects on mental health benefits, each of the mental health measures will be treated as outcome variables and modeled using linear mixed effects modeling as described in Aim 1. Aim 3: to explore correlations that can guide future research examining mediation effects, univariate correlational analyses will be employed to examine associations between baseline to 8-week change in each hypothesized CV-health and mental health related outcome.

5. Discussion There remains a dearth of evidence-based healthy lifestyle promotion interventions for incarcerated women—a group of underserved women who present numerous risk factors associated with CV disease. Our proof of concept study addresses this gap in the literature by testing an integrated indoor cycling plus health education program (IC + HEP) in a high-risk population by systematically addressing five key areas outlined by the American Heart Association for improved CV health [13,24]. Delivering this intervention to a population that bears a disproportionate burden of CV disease risk is warranted. Results from this study will provide feasibility data for developing future evidencebased interventions and programs that can impact the health of inmate populations. Findings from exploratory analysis will generate data to guide mediator and moderator hypotheses testing in next phase of research by understanding how the intervention works and for whom. Most individuals engage in multiple unhealthy behaviors (e.g., poor diet, low physical activity, and tobacco use) which can have an additive negative influence on health. Multi-behavior change interventions that target more than one at-risk behavior simultaneously within the same intervention have potential for public health impact by creating synergistic health benefits and reducing death and disease risk. Successful behavior change in one health behavior may also facilitate uptake of subsequent health behavior(s) through increases in motivation, confidence, and self-efficacy [25–27]. However, the field of multiple health behavior change, though promising, is relatively new with ongoing developments in theory and evidence-based interventions. To our knowledge, this is the first study using a multiple behavior change strategy to reduce CV-related death and disease burden in a vulnerable high-risk sample of women. Such an approach that targets a complex set of behavioral risk factors simultaneously can be an ideal model that can be integrated within other prison systems that serve similar high-risk populations and aid in improving quality of care. The structure of this intervention is advantageous because it combines indoor cycling with health education(IC + HEP) allowing for social support and commitment from the peer group, important components for health promotion and behavior change that may be lacking in women within the prison system. Moreover, results from this study can aid in guiding development of community-based health interventions using similar interventions that may be generalizable to other underserved populations to reduce CV-related death and disease.

Prison programs that promote improved physical and mental health may also facilitate reduction in recidivism rates. Reducing recidivism continues to be a challenge within the criminal justice system with lack of substance-abuse treatment programs [28,29], inadequate stress coping skills [30] and lack of social support [31] being key individuallevel predictors of recidivism. While, prison-based treatment programs using cognitive-behavioral skills training have reduced post treatment recidivism and drug use [32,33], most studies have focused exclusively on men. Our proof of concept study may address pertinent gaps in the recidivism literature and could also inform future efficacy studies that could test effects of similar interventions on recidivism rates. We understand that the study is not without limitations. The quasiexperimental design (women expressing interest in the study received the intervention) increases the probability of a self-selection bias. We chose this design due to a possibility of potential contamination of the treatment and control conditions (e.g., sharing of health education manual) as results of the closed communal setting of a prison wing. Due to limited resources and unanticipated barriers encountered working within the prison system, both intervention and control participants were recruited from the same facility. Future studies using similar strategies could use multiple sites or employ site randomization to avoid concerns of potential contamination. Moreover given the limited research in the area of multiple health behavior interventions in general as well as interventions within the prison system, our design and study findings will be informative as proof of concept of one such intervention. If preliminary feasibility and efficacy are seen, future trials may benefit from using more robust experimental designs (e.g., RCTs). In conclusion, intervention studies designed to promote healthy lifestyle behaviors among female inmates are warranted. Our intervention that intertwines health education within physical activity classes can help address gaps in health promotion and public health literatures. Proof of concept of this approach could lead to behavioral treatment research growth targeting this vulnerable population, potentially leading to interventions that create public health impact in reducing chronic disease risk associated with unhealthy lifestyles. References [1] N.K. Wenger, L.J. Shaw, V. Vaccarino, Coronary heart disease in women: update 2008, Clin. Pharmacol. Ther. 83 (2008) 37–51, http://dx.doi.org/10.1038/sj.clpt. 6100447. [2] American Heart Association, Women and cardiovascular disease, Stat. Fact Sheet 2013 Update, https://my.americanheart.org/idc/groups/heart-public/@wcm/@sop/@smd/ documents/downloadable/ucm_319576.pdf2013. [3] E.J. Benjamin, M. Jessup, J.M. Flack, H.M. Krumholz, K. Liu, V. Nadkarni, et al., Discovering the full spectrum of cardiovascular disease minority health summit 2003: report of the outcomes writing group, Circulation 111 (2005) e123–e133. [4] E.M. Stuart-Shor, K. Berra, M.W. Kamau, S. Kumanyika, Behavioral strategies for cardiovascular risk reduction in diverse and underserved racial/ethnic groups, Circulation 125 (2012) 171–184. [5] E.H. Plugge, C.E. Foster, P.L. Yudkin, N. Douglas, Cardiovascular disease risk factors and women prisoners in the UK: the impact of imprisonment, Health Promot. Int. 24 (2009) 334–343, http://dx.doi.org/10.1093/heapro/dap034. [6] E. Plugge, N. Douglas, R. Fitzpatrick, Patients, prisoners, or people? Women prisoners' experiences of primary care in prison: a qualitative study, Br. J. Gen. Pract. 58 (2008) 630–636, http://dx.doi.org/10.3399/bjgp08X330771. [7] N. Douglas, E.H. Plugge, R. Fitzpatrick, The impact of imprisonment on health: what do women prisoners say? J. Epidemiol. Community Health 63 (2009) 749–754, http://dx.doi.org/10.1136/jech.2008.080713. [8] R.H. Peters, A.L. Strozier, M.R. Murrin, W.D. Kearns, Treatment of substance-abusing jail inmates: examination of gender differences, J. Subst. Abus. Treat. 14 (1997) 339–349, http://dx.doi.org/10.1016/S0740-5472(97)00003-2. [9] T. Gray, G.L. Mays, M.K. Stohr, Inmate needs and programming in exclusively women's jails, Prison J. 75 (1995) 186–202, http://dx.doi.org/10.1177/ 0032855595075002004. [10] W. Rhodes, M. Gross, Case management reduces drug use and criminality among drug-involved arrestees: an experimental study of an HIV prevention intervention. Washington DC, https://www.ncjrs.gov/pdffiles/155281.pdf1997. [11] B.E. Richie, N. Freudenberg, J. Page, Reintegrating women leaving jail into urban communities: a description of a model program, J. Urban Health 78 (2001) 290–303, http://dx.doi.org/10.1093/jurban/78.2.290. [12] S. Fazel, J. Baillargeon, The health of prisoners, Lancet 377 (2011) 956–965, http:// dx.doi.org/10.1016/S0140-6736(10)61053-7. [13] D.M. Lloyd-Jones, Y. Hong, D. Labarthe, D. Mozaffarian, L.J. Appel, L. Van Horn, et al., Defining and setting national goals for cardiovascular health promotion and disease

U.S. Nair et al. / Contemporary Clinical Trials 48 (2016) 65–69

[14] [15] [16]

[17] [18]

[19]

[20]

[21]

[22]

[23]

reduction: the American heart association's strategic impact goal through 2020 and beyond, Circulation 121 (2010) 586–613, http://dx.doi.org/10.1161/ CIRCULATIONAHA.109.192703. R.J. Shephard, Development of the Canadian home fitness test, Can. Med. Assoc. J. 114 (1976) 675–679, http://dx.doi.org/10.2165/00007256-199111060-00002. K.F. Wells, E.K. Dillon, The sit and reach. A test of back and leg flexibility, Restor. Q. 23 (1952) 115–118. J.L. Fava, L. Ruggiero, D.M. Grimley, The development and structural confirmation of the Rhode Island stress and coping inventory, J. Behav. Med. 21 (1998) 601–611, http://dx.doi.org/10.1023/A:1018752813896. M. Rosenberg, Society and the Adolescent Self-Image, Princeon University Press, Princeton, 1965. T.F. Cash, E.C. Fleming, J. Alindogan, L. Steadman, A. Whitehead, Beyond body image as a trait: the development and validation of the body image states scale, Eat. Disord. 10 (2002) 103–113, http://dx.doi.org/10.1080/10640260290081678. R. Shwarzer, M. Jerusalem, Generalized self-efficacy scale, in: J. Weinman, S. Wright, M. Johnston (Eds.), Meas. Heal. Psychol. A User's Portfolio, Nfer-Nelson, Windsor, UK 1995, pp. 35–37. A.A. Beaton, D.C. Funk, L. Ridinger, J. Jordan, Sport involvement: a conceptual and empirical analysis, Sport Manag. Rev. 14 (2011) 126–140, http://dx.doi.org/10. 1016/j.smr.2010.07.002. S. Hollis, F. Campbell, What is meant by intention to treat analysis? Survey of published randomised controlled trials, BMJ 319 (1999) 670–674, http://dx.doi.org/10. 1136/bmj.319.7211.670. I.R. White, N.J. Horton, J. Carpenter, S.J. Pocock, Strategy for intention to treat analysis in randomised trials with missing outcome data, BMJ 342 (2011) d40, http://dx. doi.org/10.1136/bmj.d40. N.M. Laird, J.H. Ware, Random-effects models for longitudinal data, Biometrics 38 (1982) 963–974.

69

[24] A. Kulshreshtha, V. Vaccarino, S.E. Judd, V.J. Howard, W.M. McClellan, P. Muntner, et al., Life's simple 7 and risk of incident stroke: the reasons for geographic and racial differences in stroke study, Stroke 44 (2013) (1919–1914). [25] K. Emmons, B. Marcus, L. Linnan, J. Rossi, D.B. Abrams, Mechanisms in multiple risk factor interventions: smoking, physical activity, and dietary fat intake among manufacturing workers, Prev. Med. (Baltim) 23 (1994) 481–489, http://dx.doi.org/ 10.1006/pmed.1994.1066. [26] B. Spring, S. Pagoto, R. Pingitore, N. Doran, K. Schneider, D. Hedeker, Randomized controlled trial for behavioral smoking and weight control treatment: effect of concurrent versus sequential intervention, J. Consult. Clin. Psychol. 72 (2004) 785–796, http://dx.doi.org/10.1037/0022-006X.72.5.785. [27] B. Spring, A.C. Moller, M.J. Coons, Multiple health behaviours: overview and implications, J. Public Health (Oxf.) 34 (Suppl. 1) (2012) i3–10. [28] C.E. Grella, L. Greenwell, Treatment needs and completion of community-based aftercare among substance-abusing women offenders, Womens Health Issues 17 (2007) 244–255, http://dx.doi.org/10.1016/j.whi.2006.11.005. [29] B.E. Richie, Challenges incarcerated women face as they return to their communities: findings from life history interviews, Crime Delinq. 47 (2001) 368–389, http://dx.doi.org/10.1177/0011128701047003005. [30] L. Phillips, M. Lindsay, Prison to society: a mixed methods analysis of coping with reentry. Reentry, Int. J. Offender Ther. Comp. Criminol. 55 (2009) 136–154. [31] M. Berg, B.M. Huebner, No reentry and the ties that bind: an examination of social ties, employment, and recidivism, Justice Q. 28 (2011) 382–409. [32] K. Knight, D.D. Simpson, M.L. Hiller, Three-year reincarceration outcomes for inprison therapeutic community treatment in Texas, Prison J. 79 (1999) 337–351, http://dx.doi.org/10.1177/0032885599079003004. [33] B. Pelissier, M. Motivans, J.L. Rounds-Bryant, Substance abuse treatment outcomes: a multi-site study of male and female prison programs, J. Offender Rehabil. 41 (2005) 57–80, http://dx.doi.org/10.1300/J076v41n02_04.