Strong Hearts, Healthy Communities: A Community-Based Randomized Trial for Rural Women

Abstract

Objective: The aim of this study was to evaluate a multilevel cardiovascular disease (CVD) prevention program for rural women.

Methods: This 6-month, community-based, randomized trial enrolled 194 sedentary rural women aged 40 or older with BMI ≥ 25 kg/m² . Intervention participants attended 6 months of twice-weekly exercise, nutrition, and heart health classes (48 total) that included individual-, social-, and environment-level components. An education-only control program included didactic healthy lifestyle classes once a month (six total). The primary outcome measures were change in BMI and weight.

Results: Within-group and between-group multivariate analyses revealed that only intervention participants decreased BMI (-0.85 units; 95% CI: -1.32 to -0.39; P = 0.001) and weight (-2.24 kg; 95% CI: -3.49 to -0.99; P = 0.002). Compared with controls, intervention participants decreased BMI (difference: -0.71 units; 95% CI: -1.35 to -0.08; P = 0.03) and weight (1.85 kg; 95% CI: -3.55 to -0.16; P = 0.03) and improved C-reactive protein (difference: -1.15 mg/L; 95% CI: -2.16 to -0.15; P = 0.03) and Simple 7, a composite CVD risk score (difference: 0.67; 95% CI: 0.14 to 1.21; P = 0.01). Cholesterol decreased among controls but increased in the intervention group (-7.85 vs. 3.92 mg/dL; difference: 11.77; 95% CI: 0.57 to 22.96; P = 0.04).

Conclusions: The multilevel intervention demonstrated modest but superior and meaningful improvements in BMI and other CVD risk factors compared with the control program.

Trial registration: ClinicalTrials.gov NCT02499731.