Addressing the Double Burden of Malnutrition in Guatemala
NCT06750120 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1532
Last updated 2026-05-22
Summary
Globally, populations are experiencing increases in the double burden of malnutrition, commonly defined as maternal overweight/obesity and child stunting in the same household. This study will evaluate an integrated intervention combining food supplementation for pregnant and postpartum women and their infants with behavioral counseling to promote healthy maternal weight, nutrition, physical activity, and infant feeding practices. The goal is to reduce the double burden of malnutrition in rural Indigenous communities in Guatemala.
Conditions
- Maternal Obesity Complicating Pregnancy, Birth,or Puerperium
- Child Malnutrition
Interventions
- DIETARY_SUPPLEMENT
-
Family food ration
Monthly household food rations containing 5 food groups (eggs, fortified blended flour, oil, legumes, and fresh fruits and vegetables), providing approximately 150 kcal per capita per day assuming a median household of 5.
- BEHAVIORAL
-
Optimal weight counseling
Individually tailored monthly home visits by trained educators addressing healthy gestational weight gain, postpartum weight management, maternal nutrition, physical activity, and infant feeding practices.
- OTHER
-
Enhanced Usual Care
Usual care: Free pregnancy, postnatal, and infant care through the Ministry of Health services, including vitamin supplementation, infant vaccinations, and growth monitoring. Enhancements: Care navigation for high-risk or emergency conditions and ensuring infants aged 6 to 12 months receive government-recommended fortified blended flour.
Sponsors & Collaborators
-
Wuqu' Kawoq, Maya Health Alliance
collaborator OTHER -
Instituto de Nutricion de Centroamerica y Panama (INCAP)
collaborator UNKNOWN - collaborator OTHER
-
Harvard Medical School (HMS and HSDM)
collaborator OTHER -
Brigham and Women's Hospital
lead OTHER
Principal Investigators
-
Peter Rohloff, MD PhD · Brigham and Women's Hospital
-
Manuel Ramirez, MD PhD · Institute of Nutrition of Central America and Panama
-
David Flood, MD MSc · University of Michigan
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-14
- Primary Completion
- 2029-05-31
- Completion
- 2029-08-31
Countries
- Guatemala
Study Locations
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