Abstract
BACKGROUND: We evaluated the effectiveness of a structured family-based cardiovascular health promotion intervention model in improving weight management among adults. METHODS: We conducted an open label, cluster randomized controlled trial (ClinicalTrials.gov NCT02771873) with families serving as the unit of intervention. Families were randomly assigned via computer-generated numbers to receive either the comprehensive package of interventions or enhanced usual care in a 1:1 ratio. Nonphysician health workers delivered the comprehensive package of interventions, which included annual screening for cardiovascular risk factors, structured lifestyle modification sessions, referral to a primary health care facility for individuals with established risk factors, and active follow-up to evaluate self-care adherence. Weight, body mass index (BMI), and waist circumference were measured at baseline, 1 year, and 2 years to assess the intervention's effect on weight management. We used a generalized estimating equation model to analyze the between-group population average changes in these anthropometric parameters. RESULTS: In total, 1,671 participants (1,111 women) from 750 families participated. The mean age of the study population was 40.8 (SD = 14.2) years. The attrition rate at the 2-year follow-up was 3%. The adjusted population average change attributable to the intervention at the 2-year follow-up were -2.61 kg in weight (95% CI, -3.95 to -1.26; P <.001), -1.06 kg/m(2) in BMI (95% CI, -1.55 to -0.58; P <.001), and -4.17 cm in waist circumference (95% CI, -5.38 to -2.96; P <.001). CONCLUSION: The reduction in weight achieved in the family-based intervention could have a substantial public health impact in preventing future diabetes and other noncommunicable disease conditions.