Clinical trial

Addressing the Double Burden of Malnutrition in Guatemala

Recruiting now · Not applicable · 1 countries · Registry ID NCT06750120

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age16 Years to Not listed

SexFemale

Healthy volunteersNot accepted

ConditionMaternal Obesity Complicating Pregnancy, Birth,or Puerperium, Child Malnutrition

Full registry criteria

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

Treatments and study arms

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

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.

Primary outcomes

Child length-for-age z score12 months of age

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

Maternal weight12 months postpartum

Mean maternal weight in kilograms at 12 months postpartum

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Community recruitment🌐 Tecpán Guatemala, Departamento de Chimaltenango, Guatemala

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Peter RohloffContact