An interventional study of Family food ration and Optimal weight counseling in Maternal Obesity Complicating Pregnancy, Birth,or Puerperium and Child Malnutrition, sponsored by Brigham and Women's Hospital. Recruiting at 1 site in Guatemala. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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.
K'ASLEM (meaning "life" in the Kaqchikel Mayan language) is an individually randomized, parallel-group Hybrid Type 1 effectiveness-implementation clinical trial conducted in Indigenous Maya communities in Guatemala that have among the world's highest levels of double burden of malnutrition. The trial will enroll 766 pregnant women aged 16 years or older before 28 weeks gestation with 1:1 allocation to intervention and comparator arms. The intervention arm will receive two integrated interventions: (a) food supplementation for pregnant and postpartum women and for infants and (b) behavioral counseling to optimize maternal weight and promote healthy nutrition, physical activity, and infant feeding practices. The comparator is enhanced usual care, which includes routine government prenatal and postnatal services along with care navigation and provision of fortified flour for infants. Mother-child dyads will be followed until 12 months after birth. Co-primary outcomes are maternal weight and child length-for-age at 12 months after birth. Complementing these trial outcomes, the study will collect mixed-methods data on implementation outcomes and apply implementation mapping to develop strategies for future scale-up. The trial will also include an economic evaluation to inform policymakers of costs and cost-effectiveness. A major feature of the trial is a focus on pragmatism and fairness, working to enroll vulnerable families from rural Guatemala who stand most to benefit from the intervention but who are commonly excluded from clinical trials.
167 studies on the registry are indexed under Child Nutrition Disorders; 36 are open to participants now.
This study's planned enrollment of 1,532 is above the median of 402 across 132 interventional studies indexed under Child Nutrition Disorders.
Browse Child Nutrition Disorders studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive two integrated interventions from enrollment through 12 months postpartum. (1) Food supplementation: Monthly household food rations containing 5 food groups, designed to address dietary quality gaps for both mothers and infants; and (2) Behavioral counseling: Individually tailored monthly home visits by trained educators to optimize maternal weight and promote healthy nutrition, physical activity, and infant feeding practices. Participants in the intervention arm will also receive enhanced usual care as described for the comparator arm.
Dietary Supplement: Family food ration · Behavioral: Optimal weight counseling · Other: Enhanced Usual Care
The comparator is enhanced usual care. Usual care includes free pregnancy, postnatal, and infant care through the Ministry of Health services. Two enhancements are provided: (1) Enrollment in Maya Health Alliance's care navigation program, which supports women and infants with high-risk or emergency conditions; and (2) Ensuring that infants aged 6 to 12 months receive the government-recommended monthly provision of fortified blended flour.
Other: Enhanced Usual Care
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.
Individually tailored monthly home visits by trained educators addressing healthy gestational weight gain, postpartum weight management, maternal nutrition, physical activity, and infant feeding practices.
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.
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
Maternal weight
Mean maternal weight in kilograms at 12 months postpartum
Time frame: 12 months postpartum
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
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
Maternal overweight/obesity
Proportion of women with body mass index 25 kg/m\^2 or greater
Time frame: 12 months postpartum
Maternal hemoglobin
Mean hemoglobin concentration in g/dL
Time frame: 12 months postpartum
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data underlying published primary and secondary analyses, including demographic, anthropometric, laboratory, and questionnaire data.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Beginning at the time of publication of the main study paper or completion of primary study data collection and cleaning, whichever comes first, with no end date.
Access criteria: All data will be stored and accessible through the NICHD DASH repository, following standard procedure for that repositoiry, requiring the completion of a Data Use Agreement which prohibits any redistribution or attempts to re-identify research participants.
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