A Coordinated Community- and Family-Based Intervention to Control Blood Pressure in Rural China: A Cluster-Randomized Trial.

BACKGROUND: Current hypertension prevention strategies predominantly focus on identifying and treating individuals with established hypertension. Whether a coordinated community- and family-based intervention can shift the population distribution of systolic blood pressure (SBP) remains uncertain. OBJECTIVES: The purpose of this study was to evaluate whether a coordinated, community- and family-centered intervention could shift the distribution of SBP at the population level in rural China. METHODS: In this cluster-randomized trial conducted in rural China, village clusters comprising adults aged 40 to 80 years, irrespective of blood pressure (BP) level or hypertension status, were randomly assigned (1:1) to a multifaceted intervention or usual care. The intervention included community instructor support, potassium-enriched low-sodium salt substitute, home BP and weight monitoring, physical activity promotion, and facilitation of antihypertensive treatment during an initial 6-month active intervention phase, followed by continued digital BP monitoring support through 12 months. Office BP was measured at baseline and at 6 and 12 months by trained staff independent of the intervention team. The primary outcome was the between-group difference in change in SBP from baseline to 6 months. Analyses followed the intention-to-treat principle using linear mixed-effects regression models. RESULTS: A total of 80 village clusters, comprising 8,001 participants, underwent randomization. Baseline mean SBP was 133.1 mm Hg in the intervention group and 131.4 mm Hg in the control group. At 6 months, mean SBP fell by 6.0 mm Hg in the intervention group and increased by 5.1 mm Hg in the control group, resulting in an adjusted between-group difference of -10.7 mm Hg (95% CI: -11.8 to -9.6 mm Hg). BP <130/80 mm Hg was achieved in 46.2% of participants in the intervention group vs 23.6% in the control group (adjusted OR: 5.3; 95% CI: 4.3-6.6). At 12 months, the adjusted between-group difference in SBP was -3.7 mm Hg (95% CI: -4.9 to -2.6 mm Hg). Serious adverse events occurred in 2.8% of participants in the intervention group and 2.3% in the control group. CONCLUSIONS: In rural China, a coordinated community- and family-based intervention significantly shifted the population distribution of SBP toward lower levels over 6 months. Attenuation of the treatment effect over time suggests that sustained population BP reduction may require ongoing implementation infrastructure and continued community support. (Effect of Healthy Family Program on Population Blood Pressure; NCT06427096).