Addressing the Double Burden of Malnutrition in Guatemala

NCT06750120 | Recruiting DMC

• 1 other identifier: 2024P003339
• Study Type: interventional
• Target: 1,532
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Guatemala; stunting; maternal obesity; food supplementation; lifestyle counseling; child malnutrition

Outcome Measures

Primary Outcomes (2)

• Child length-for-age z score

  Mean length-for-age z score (LAZ) at 12 months of age using WHO Child Growth Standards

  12 months of age

• Maternal weight

  Mean maternal weight in kilograms at 12 months postpartum

  12 months postpartum

Secondary Outcomes (4)

• Child stunting

  12 months of age

• Child global development score

  12 months of age

• Maternal overweight/obesity

  12 months postpartum

• Maternal hemoglobin

  12 months postpartum

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Dietary Supplement: Family food ration; Behavioral: Optimal weight counseling; Other: Enhanced Usual Care

Enhanced Usual Care Arm

ACTIVE COMPARATOR

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.

Other: Enhanced Usual Care

Interventions

Family food ration DIETARY_SUPPLEMENT

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.

Intervention Arm

Optimal weight counseling BEHAVIORAL

Individually tailored monthly home visits by trained educators addressing healthy gestational weight gain, postpartum weight management, maternal nutrition, physical activity, and infant feeding practices.

Intervention Arm

Enhanced Usual Care OTHER

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.

Enhanced Usual Care Arm; Intervention Arm

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women aged 16 years or older
• Gestational age less than 28 weeks

You may not qualify if:

• History of pregestational diabetes (type 1 or type 2), history of gestational diabetes in a previous pregnancy, or diagnosis of gestational diabetes in the current pregnancy
• Multifetal gestation (twins or higher-order pregnancies)
• Currently participating in another research study involving an intervention
• Has a family member who has already been invited to participate in this study and/or shares a kitchen with such a person
• Has a serious underlying medical or psychiatric condition requiring specialized clinical care, including active cancer, severe renal or hepatic disease, symptomatic heart disease, autoimmune disorders requiring immunosuppressive therapy, active thromboembolism or coagulopathy, or severe mental health condition, or other conditions at the discretion of the investigators
• Plans to move out of the study area within the next two years

Sponsors & Collaborators

• Wuqu' Kawoq, Maya Health Alliance: collaborator
• University of Michigan: collaborator
• Brigham and Women's Hospital: lead
• Harvard Medical School (HMS and HSDM): collaborator
• Instituto de Nutricion de Centroamerica y Panama (INCAP): collaborator

Study Sites (1)

Community recruitment

Tecpán Guatemala, Departamento de Chimaltenango, Guatemala

RECRUITING

Related Publications (1)

• Popkin BM, Corvalan C, Grummer-Strawn LM. Dynamics of the double burden of malnutrition and the changing nutrition reality. Lancet. 2020 Jan 4;395(10217):65-74. doi: 10.1016/S0140-6736(19)32497-3. Epub 2019 Dec 15.

  PMID: 31852602 BACKGROUND

MeSH Terms

Conditions

Child Nutrition Disorders; Growth Disorders; Pregnancy in Obesity

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overweight; Overnutrition; Body Weight; Signs and Symptoms

Study Officials

• Peter Rohloff, MD PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Manuel Ramirez, MD PhD

  Institute of Nutrition of Central America and Panama

  PRINCIPAL INVESTIGATOR

• David Flood, MD MSc

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Rohloff, MD PhD

CONTACT

617-732-5500; prohloff@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 27, 2024
• Study Start: May 14, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning at the time of publication of the main study paper or completion of primary study data collection and cleaning, whichever comes first, with no end date.
• Access Criteria: All data will be stored and accessible through the NICHD DASH repository, following standard procedure for that repositoiry, requiring the completion of a Data Use Agreement which prohibits any redistribution or attempts to re-identify research participants.

Locations

GU (1)