Effect of a digitally-enabled, stage-based intervention on maternal and child health: a community-based, cluster-randomized controlled trial from rural China

Abstract Background Comprehensive and responsive interventions are increasingly advocated to address the diverse and evolving health challenges faced by mothers and children during the first 1,000 days of life. However, evidence remains limited on how such interventions can be operationalized in low-resource settings without overstretching frontline health workers. We developed the Healthy Future program, a digitally-enabled community health worker (CHW) intervention that integrates a comprehensive and stage-based maternal and child health curriculum with digital infrastructure to deliver developmentally appropriate support through home visits. We evaluated the effects of the program on multidimensional outcomes, including caregiving practice, child health and nutrition, and caregiver well-being in rural China. Methods and Findings We conducted a cluster-randomized controlled trial across 119 rural townships in Sichuan Province, China, with 40 randomly assigned to receive the program delivered by township-level CHWs and 79 serving as controls. The trial enrolled 1,306 families with pregnant women or infants younger than six months and implemented the intervention for 12 months from August 2021 to September 2022. Among intervention families, 82% participated in at least one home visit and participating families received 10.5 home visits on average, with 4856 visits delivered in total. Follow-up data were collected from 1,149 families (88%). The main analysis used an intent-to-treat approach. For the three primary outcomes, the intervention did not significantly improve hemoglobin concentration or exclusive breastfeeding, although dietary diversity increased modestly by 0.207 food groups (95% CI: 0.015 to 0.399; p=0.035). Among secondary outcomes, the intervention reduced the occurrence of child illness during the previous two weeks by 8.2 percentage points (14.0 to 2.4; p=0.006) and improved breastfeeding initiation practices, including ever breastfeeding (3.2 percentage points; 1.1 to 5.3; p=0.002) and colostrum feeding (4.4 percentage points; 0.1 to 8.6; p=0.044). The intervention also improved caregiving knowledge index (0.189 standard deviations; 0.084 to 0.294; p