Addressing the Double Burden of Malnutrition in Guatemala

May 20, 2026 updated by: Peter J. Rohloff, M.D.,Ph.D., Brigham and Women's Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1532

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Child length-for-age z score
Time Frame: 12 months of age
Mean length-for-age z score (LAZ) at 12 months of age using WHO Child Growth Standards
12 months of age
Maternal weight
Time Frame: 12 months postpartum
Mean maternal weight in kilograms at 12 months postpartum
12 months postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child stunting
Time Frame: 12 months of age
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
Time Frame: 12 months of age
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
Time Frame: 12 months postpartum
Proportion of women with body mass index 25 kg/m^2 or greater
12 months postpartum
Maternal hemoglobin
Time Frame: 12 months postpartum
Mean hemoglobin concentration in g/dL
12 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Harvard Medical School (HMS and HSDM)
University of Michigan
Wuqu' Kawoq, Maya Health Alliance
Instituto de Nutricion de Centroamerica y Panama (INCAP)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 14, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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