Addressing the Double Burden of Malnutrition in Guatemala

NCT06750120 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1532

Last updated 2026-05-22

No results posted yet for this study

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
  • University of Michigan

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06750120 on ClinicalTrials.gov