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Strong hearts, healthy communities: a community-based randomized trial for rural women |
Seguin RA, Paul L, Folta SC, Nelson ME, Strogatz D, Graham ML, Diffenderfer A, Eldridge G, Parry SA |
Obesity 2018 May;26(5):845-853 |
clinical trial |
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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 versus 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.
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