Rae Jean Proeschold-Bell1, Elizabeth L Turner2, Gary G Bennett3, Jia Yao4, Xiang-Fang Li5, David E Eagle4, Rachel A Meyer5, Redford B Williams6, Robin Y Swift5, H Edgar Moore5, Melanie A Kolkin5, Carl C Weisner5, Katherine M Rugani5, Holly J Hough5, Virginia P Williams7, David C Toole8. 1. Duke Global Health Institute, Duke Center for Health Policy and Inequalities Research, Durham, North Carolina. Electronic address: rae.jean@duke.edu. 2. Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina; Duke Global Health Institute, Duke University, Durham, North Carolina. 3. Duke Global Health Institute, Duke University, Durham, North Carolina; Department of Psychology and Neuroscience, Duke University, Durham, North Carolina. 4. Duke Global Health Institute, Duke Center for Health Policy and Inequalities Research, Durham, North Carolina. 5. Duke Divinity School, Durham, North Carolina. 6. Department of Psychology and Neuroscience, Duke University, Durham, North Carolina; Department of Psychiatry and Behavioral Sciences, Duke University, Durham, North Carolina; Behavioral Medicine Research Center, Duke University, Durham, North Carolina; Williams LifeSkills, Inc., Durham, North Carolina. 7. Williams LifeSkills, Inc., Durham, North Carolina. 8. Duke Global Health Institute, Duke University, Durham, North Carolina; Duke Divinity School, Durham, North Carolina.
Abstract
INTRODUCTION: This study sought to determine the effect of a 2-year, multicomponent health intervention (Spirited Life) targeting metabolic syndrome and stress simultaneously. DESIGN: An RCT using a three-cohort multiple baseline design was conducted in 2010-2014. SETTING/PARTICIPANTS: Participants were United Methodist clergy in North Carolina, U.S., in 2010, invited based on occupational status. Of invited 1,745 clergy, 1,114 consented, provided baseline data, and were randomly assigned to immediate intervention (n=395), 1-year waitlist (n=283), or 2-year waitlist (n=436) cohorts for a 48-month trial duration. INTERVENTION: The 2-year intervention consisted of personal goal setting and encouragement to engage in monthly health coaching, an online weight loss intervention, a small grant, and three workshops delivering stress management and theological content supporting healthy behaviors. Participants were not blinded to intervention. MAIN OUTCOME MEASURES: Trial outcomes were metabolic syndrome (primary) and self-reported stress and depressive symptoms (secondary). Intervention effects were estimated in 2016 in an intention-to-treat framework using generalized estimating equations with adjustment for baseline level of the outcome and follow-up time points. Log-link Poisson generalized estimating equations with robust SEs was used to estimate prevalence ratios (PRs) for binary outcomes; mean differences were used for continuous/score outcomes. RESULTS: Baseline prevalence of metabolic syndrome was 50.9% and depression was 11.4%. The 12-month intervention effect showed a benefit for metabolic syndrome (PR=0.86, 95% CI=0.79, 0.94, p<0.001). This benefit was sustained at 24 months of intervention (PR=0.88; 95% CI=0.78, 1.00, p=0.04). There was no significant effect on depression or stress scores. CONCLUSIONS: The Spirited Life intervention improved metabolic syndrome prevalence in a population of U.S. Christian clergy and sustained improvements during 24 months of intervention. These findings offer support for long-duration behavior change interventions and population-level interventions that allow participants to set their own health goals. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01564719.
RCT Entities:
INTRODUCTION: This study sought to determine the effect of a 2-year, multicomponent health intervention (Spirited Life) targeting metabolic syndrome and stress simultaneously. DESIGN: An RCT using a three-cohort multiple baseline design was conducted in 2010-2014. SETTING/PARTICIPANTS: Participants were United Methodist clergy in North Carolina, U.S., in 2010, invited based on occupational status. Of invited 1,745 clergy, 1,114 consented, provided baseline data, and were randomly assigned to immediate intervention (n=395), 1-year waitlist (n=283), or 2-year waitlist (n=436) cohorts for a 48-month trial duration. INTERVENTION: The 2-year intervention consisted of personal goal setting and encouragement to engage in monthly health coaching, an online weight loss intervention, a small grant, and three workshops delivering stress management and theological content supporting healthy behaviors. Participants were not blinded to intervention. MAIN OUTCOME MEASURES: Trial outcomes were metabolic syndrome (primary) and self-reported stress and depressive symptoms (secondary). Intervention effects were estimated in 2016 in an intention-to-treat framework using generalized estimating equations with adjustment for baseline level of the outcome and follow-up time points. Log-link Poisson generalized estimating equations with robust SEs was used to estimate prevalence ratios (PRs) for binary outcomes; mean differences were used for continuous/score outcomes. RESULTS: Baseline prevalence of metabolic syndrome was 50.9% and depression was 11.4%. The 12-month intervention effect showed a benefit for metabolic syndrome (PR=0.86, 95% CI=0.79, 0.94, p<0.001). This benefit was sustained at 24 months of intervention (PR=0.88; 95% CI=0.78, 1.00, p=0.04). There was no significant effect on depression or stress scores. CONCLUSIONS: The Spirited Life intervention improved metabolic syndrome prevalence in a population of U.S. Christian clergy and sustained improvements during 24 months of intervention. These findings offer support for long-duration behavior change interventions and population-level interventions that allow participants to set their own health goals. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01564719.
Authors: Rae Jean Proeschold-Bell; Dori M Steinberg; Jia Yao; David E Eagle; Timothy W Smith; Grace Y Cai; Elizabeth L Turner Journal: Transl Behav Med Date: 2020-02-03 Impact factor: 3.046