Health Trials

Addressing the Double Burden of Malnutrition in Guatemala

ConditionsMaternal Obesity Complicating Pregnancy, Birth,or PuerperiumChild Malnutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16+
SponsorBrigham and Women's Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant women aged 16 years or older

Gestational age less than 28 weeks

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • Enhanced Usual Care

    Other intervention

    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.

Treatment groups

1,532 Participants
are divided into 2 treatment groups
Group A: Intervention ArmExperimental treatment 3 interventions
Group B: Enhanced Usual Care ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Child length-for-age z score

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

Time frame
12 months of age
2

Maternal weight

Mean maternal weight in kilograms at 12 months postpartum

Time frame
12 months postpartum

Secondary outcomes

1

Child stunting

Proportion of children with length-for-age z score less than -2 using WHO Child Growth Standards

Time frame
12 months of age
2

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)

Time frame
12 months of age
3

Maternal overweight/obesity

Proportion of women with body mass index 25 kg/m\^2 or greater

Time frame
12 months postpartum
4

Maternal hemoglobin

Mean hemoglobin concentration in g/dL

Time frame
12 months postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Wuqu' Kawoq, Maya Health Alliance

Collaborator

Instituto de Nutricion de Centroamerica y Panama (INCAP)

Collaborator

University of Michigan

Collaborator

Harvard Medical School (HMS and HSDM)

Collaborator

Source ClinicalTrials.gov
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