Addressing the Double Burden of Malnutrition in Guatemala
Official title: An Integrated Intervention to Address the Double Burden of Malnutrition in Guatemala
Run by Brigham and Women's Hospital · NCT06750120 · Data updated 2026-11-12
This trial tests a combined food support and lifestyle counseling program for pregnant and postpartum women and their infants in rural Guatemala to see if it reduces the in-house problem of maternal overweight/obesity and child stunting.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years and up |
| Sex | Women only |
| Enrollment | 1532 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Tecpán Guatemala, Departamento de Chimaltenango) |
| Status | Recruiting |
| Started | May 14, 2026 |
| Main results expected | May 2029 |
| Study ends | August 2029 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT06750120 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women aged 16 years or older with gestational age under 28 weeks, residing in rural Guatemala and willing to participate through 12 months after birth.
✕Probably not a fit
People outside the trial area or those not meeting gestational age criteria, or with conditions requiring specialized care, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
K'ASLEM is an individually randomized trial in Indigenous Maya communities in Guatemala testing two integrated components: food supplementation for pregnant/postpartum women and infants, plus behavioral counseling on healthy weight, nutrition, activity, and infant feeding. Participants are pregnant women under 28 weeks gestation, assigned 1:1 to receive the combined intervention or enhanced usual care, and followed through 12 months after birth. The study also collects implementation data, conducts an economic evaluation, and aims to inform scale-up strategies while prioritizing enrollment of vulnerable families. Primary outcomes include maternal weight and child length-for-age at 12 months, with additional mixed-methods data on feasibility and impact. The trial emphasizes pragmatism and fairness in reaching rural communities with high need.
Why it matters
Potential benefit: If successful, the program could improve maternal weight profiles and child growth, potentially reducing stunting in the next generation.
How similar studies have gone: This approach combines nutrition supplementation with behavior change and has shown promise in similar settings, though the specific program in Guatemala is relatively novel and pragmatic in design.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Community recruitment
Tecpán Guatemala, Departamento de Chimaltenango, Guatemala Recruiting
Study contacts
- Principal investigator: Peter Rohloff, MD PhD — Brigham and Women's Hospital
- Study coordinator: Peter Rohloff, MD PhD
- Email: prohloff@bwh.harvard.edu
- Phone: 617-732-5500
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.