Integrated Food Supplementation and Behavioral Counseling for Pregnant Women to Combat Malnutrition in Guatemala

What this Trial Is About

Researchers are evaluating an integrated approach to reduce the double burden of malnutritionmaternal overweight or obesity alongside child stuntingin rural Indigenous Maya communities in Guatemala. This trial focuses on pregnant women aged 16 years or older, aiming to improve maternal weight and child growth outcomes. It is a randomized, parallel-group trial enrolling 766 pregnant women before 28 weeks of gestation and follows mother-child pairs until 12 months after birth. The study compares two groups one receiving an integrated intervention of monthly household food rations containing key food groups and individually tailored behavioral counseling on maternal weight, nutrition, physical activity, and infant feeding practices and a comparator group receiving enhanced usual care. Usual care includes free prenatal and postnatal services, care navigation for high-risk conditions, and fortified blended flour for infants aged 6 to 12 months. The intervention period spans from enrollment through 12 months postpartum. Participants will have monthly home visits for counseling and receive food supplements designed to address dietary gaps for mothers and infants. Researchers will assess maternal weight and child length-for-age at 12 months postpartum as primary outcomes. Secondary outcomes include child stunting, child development, maternal overweightobesity, and maternal hemoglobin levels. The study also collects data to support future program scaling and economic evaluations, with safety and adherence monitored throughout the follow-up period lasting until one year after birth.

Addressing the Double Burden of Malnutrition in Guatemala