Summary: In a 2-year open-label cluster randomized controlled trial of 1,671 adults from 750 families in India, a structured family-based cardiovascular health promotion programme delivered by nonphysician health workers reduced body weight by an adjusted 2.61 kg (95% CI -3.95 to -1.26; p<0.001) versus enhanced usual care, with parallel reductions in BMI and waist circumference.
PICO Summary
| Element | Detail |
|---|---|
| Population | 1,671 adults (1,111 women) from 750 families, mean age 40.8 years; community-dwelling adults in India. Open-label cluster RCT with families as the unit of randomization; 3% attrition at 2 years. |
| Intervention | Structured family-based cardiovascular health promotion delivered by nonphysician health workers: annual risk-factor screening, structured lifestyle-modification sessions, primary-care referral, and active adherence follow-up. Randomized 1:1 at the family level. |
| Comparison | Enhanced usual care, also randomized 1:1 at the family level. |
| Outcome | Adjusted population-average change attributable to the intervention at 2 years: weight -2.61 kg (95% CI -3.95 to -1.26; p<0.001), BMI -1.06 kg/m2 (95% CI -1.55 to -0.58; p<0.001), waist circumference -4.17 cm (95% CI -5.38 to -2.96; p<0.001). Analyzed by generalized estimating equations. No diabetes or cardiovascular event endpoints were reported; benefit on those outcomes is inferred, not measured. |
Family-Based Weight Management in Adults
Cluster RCT · adults in India · 2 years
A family-based, health-worker-delivered programme cut adult body weight by an adjusted 2.61 kg versus enhanced usual care, sustained at 2 years, with parallel BMI and waist reductions.
Expert Commentary
This is a credible, adequately powered cluster randomized trial, and the verdict is that a family-anchored, health-worker-delivered programme produced a modest but statistically robust weight reduction sustained to 2 years, with consistent BMI and waist-circumference signals pointing the same direction. The 3% attrition is unusually low and strengthens confidence in the estimates. The design merits scrutiny on one point in particular: the trial was open-label, so participants and the nonphysician workers delivering the sessions were aware of allocation, which can inflate behavioural adherence and self-reported lifestyle change. Reassuringly, the primary outcomes were objectively measured anthropometry rather than self-report, which blunts that concern. The funding was NIH extramural and academic, with no industry or device manufacturer sponsorship, and the effect sizes are clinically plausible rather than implausibly large. The principal limitation is that this trial measured surrogate anthropometric endpoints only; the projected reductions in diabetes and other noncommunicable disease are extrapolated, not demonstrated. Can I use this with my patients? Cautiously yes, for community or primary-care patients in resource-limited settings where family-based, task-shifted lifestyle programmes are feasible; it is less directly transferable to individual clinic visits in high-income systems. Pragmatic trials reporting hard cardiometabolic endpoints would be a welcome next step.
References
Panniyammakal J, Stanley A, Ismail S, Lekha TR, Ganapathi S, Harikrishnan S. Family-Based Interventions to Promote Weight Management in Adults: Results From a Cluster Randomized Controlled Trial in India. Ann Fam Med. 2025;23(2):93-99. doi:10.1370/afm.230632