An Integrated Intervention to Address the Double Burden of Malnutrition in Guatemala
Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Healthy Volunteers: f
View:
• Pregnant women aged 16 years or older
• Gestational age less than 28 weeks
Locations
Other Locations
Guatemala
Community recruitment
RECRUITING
Tecpán Guatemala
Contact Information
Primary
Peter Rohloff, MD PhD
prohloff@bwh.harvard.edu
617-732-5500
Time Frame
Start Date: 2026-05-14
Estimated Completion Date: 2029-08
Participants
Target number of participants: 1532
Treatments
Experimental: Intervention Arm
Participants will receive two integrated interventions from enrollment through 12 months postpartum. (1) Food supplementation: Monthly household food rations containing 5 food groups, designed to address dietary quality gaps for both mothers and infants; and (2) Behavioral counseling: Individually tailored monthly home visits by trained educators to optimize maternal weight and promote healthy nutrition, physical activity, and infant feeding practices. Participants in the intervention arm will also receive enhanced usual care as described for the comparator arm.
Active_comparator: Enhanced Usual Care Arm
The comparator is enhanced usual care. Usual care includes free pregnancy, postnatal, and infant care through the Ministry of Health services. Two enhancements are provided: (1) Enrollment in Maya Health Alliance's care navigation program, which supports women and infants with high-risk or emergency conditions; and (2) Ensuring that infants aged 6 to 12 months receive the government-recommended monthly provision of fortified blended flour.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: Wuqu' Kawoq, Maya Health Alliance, University of Michigan, Instituto de Nutricion de Centroamerica y Panama (INCAP), Harvard Medical School (HMS and HSDM)