Addressing the Double Burden of Malnutrition in Guatemala

An Integrated Intervention to Address the Double Burden of Malnutrition in Guatemala

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.

Study Overview

• Status: Recruiting
• Conditions: Child Malnutrition; Maternal Obesity Complicating Pregnancy, Birth,or Puerperium
• Intervention / Treatment: Dietary supplement: Family food ration; Behavioral: Optimal weight counseling; Other: Enhanced Usual Care

Detailed Description

K'ASLEM (meaning "life" in the Kaqchikel Mayan language) is an individually randomized, parallel-group Hybrid Type 1 effectiveness-implementation clinical trial conducted in Indigenous Maya communities in Guatemala that have among the world's highest levels of double burden of malnutrition. The trial will enroll 766 pregnant women aged 16 years or older before 28 weeks gestation with 1:1 allocation to intervention and comparator arms. The intervention arm will receive two integrated interventions: (a) food supplementation for pregnant and postpartum women and for infants and (b) behavioral counseling to optimize maternal weight and promote healthy nutrition, physical activity, and infant feeding practices. The comparator is enhanced usual care, which includes routine government prenatal and postnatal services along with care navigation and provision of fortified flour for infants. Mother-child dyads will be followed until 12 months after birth. Co-primary outcomes are maternal weight and child length-for-age at 12 months after birth. Complementing these trial outcomes, the study will collect mixed-methods data on implementation outcomes and apply implementation mapping to develop strategies for future scale-up. The trial will also include an economic evaluation to inform policymakers of costs and cost-effectiveness. A major feature of the trial is a focus on pragmatism and fairness, working to enroll vulnerable families from rural Guatemala who stand most to benefit from the intervention but who are commonly excluded from clinical trials.

• Study Type: Interventional
• Enrollment (Estimated): 1532
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Rohloff, MD PhD; Phone Number: 617-732-5500; Email: prohloff@bwh.harvard.edu

Study Locations

• Guatemala
  • Departamento de Chimaltenango
    • Tecpán Guatemala, Departamento de Chimaltenango, Guatemala
      • Recruiting
      • Community recruitment
      • Contact: Peter Rohloff

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child stunting	Proportion of children with length-for-age z score less than -2 using WHO Child Growth Standards	12 months of age
Child global development score	Mean overall global development raw scaled (factor) score from the Caregiver Reported Early Development Instruments (CREDI) long form (range 0 to 117, higher scores indicate more advanced development)	12 months of age
Maternal overweight/obesity	Proportion of women with body mass index 25 kg/m^2 or greater	12 months postpartum
Maternal hemoglobin	Mean hemoglobin concentration in g/dL	12 months postpartum

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Harvard Medical School (HMS and HSDM); University of Michigan; Wuqu' Kawoq, Maya Health Alliance; Instituto de Nutricion de Centroamerica y Panama (INCAP)
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: stunting; Guatemala; food supplementation; child malnutrition; lifestyle counseling; maternal obesity
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Nutrition Disorders; Female Urogenital Diseases and Pregnancy Complications; Overnutrition; Body Weight; Pregnancy Complications; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Child Nutrition Disorders; Growth Disorders; Pregnancy in Obesity
• Other Study ID Numbers: 2024P003339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying published primary and secondary analyses, including demographic, anthropometric, laboratory, and questionnaire data.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No