Addressing the Double Burden of Malnutrition in Guatemala
Recruiting · NCT06750120 · Interventional (participants receive a specific treatment) · Lead sponsor: Brigham and Women's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Enhanced Usual CareFamily food rationOptimal weight counseling
What this trial 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.
Who can take part
Age range
16 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Community recruitment - Tecpán Guatemala, Departamento de Chimaltenango, Guatemala