RecruitingNot ApplicableNCT06750120

Addressing the Double Burden of Malnutrition in Guatemala

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


Sponsor

Brigham and Women's Hospital

Enrollment

1,532 participants

Start Date

May 14, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 16 Years

Inclusion Criteria2

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

Exclusion Criteria6

  • 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

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Interventions

DIETARY_SUPPLEMENTFamily 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.

BEHAVIORALOptimal 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.

OTHEREnhanced 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.


Locations(1)

Community recruitment

Tecpán Guatemala, Departamento de Chimaltenango, Guatemala

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NCT06750120


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