The Strong Hearts, Healthy Communities Program 2.0: An RCT Examining Effects on Simple 7.
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INTRODUCTION: Rural women have higher rates of cardiovascular disease than their nonrural counterparts, partially because of their social and environmental contexts. The study objective is to test a refined version of the multilevel Strong Hearts, Healthy Communities intervention, which used extensive process and outcome evaluation data from the original randomized trial to optimize effectiveness as measured by improved Simple 7 score, a composite measure of cardiovascular disease risk. STUDY DESIGN: The intervention was implemented in a 6-month, delayed intervention, community-randomized trial; control participants received the program following 24-week outcome assessment. The study was conducted in 2017-2018; data analysis occurred in 2018-2019. SETTING/PARTICIPANTS: The study was conducted in 11 rural, medically underserved towns in New York. Participants were women aged 40 years who were either (1) obese or (2) overweight and sedentary. INTERVENTION: The intervention group received 24 weeks of hour-long, twice-weekly classes including strength training, aerobic exercise, and skill-based nutrition- and health-related education, as well as civic engagement activities focused on healthy food and physical activity environments. MAIN OUTCOME MEASURES: Measures included weight and height; blood pressure; blood cholesterol; blood glucose; and self-reported smoking, diet, and physical activity behaviors. Individual Simple 7 components were examined, and mixed linear regression analyses were used to examine change in Simple 7 score. RESULTS: A total of 182 participants were randomized. Compared with control participants, the intervention group had greater improvements in Simple 7 score (difference=1.03, 95% CI=0.44, 1.61, p<0.001) and 3 of the Simple 7 components (physical activity, healthy diet score, and BMI). CONCLUSIONS: These findings highlight the importance of rigorously evaluating programs in real-world community settings and, when appropriate, revising and retesting interventions to optimize dissemination potential. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT03059472.
