Child Malnutrition, Maternal Obesity Complicating Pregnancy, Birth,or Puerperium
Conditions
Keywords
Guatemala, stunting, maternal obesity, food supplementation, lifestyle counseling, child malnutrition
Brief 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.
Detailed description
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.
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.
Sponsors
Brigham and Women's Hospital
Wuqu' Kawoq, Maya Health Alliance
Instituto de Nutricion de Centroamerica y Panama (INCAP)
University of Michigan
Harvard Medical School (HMS and HSDM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child length-for-age z score | 12 months of age | Mean length-for-age z score (LAZ) at 12 months of age using WHO Child Growth Standards |
| Maternal weight | 12 months postpartum | Mean maternal weight in kilograms at 12 months postpartum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child stunting | 12 months of age | Proportion of children with length-for-age z score less than -2 using WHO Child Growth Standards |
| Child global development score | 12 months of age | 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) |
| Maternal overweight/obesity | 12 months postpartum | Proportion of women with body mass index 25 kg/m\^2 or greater |
| Maternal hemoglobin | 12 months postpartum | Mean hemoglobin concentration in g/dL |
Countries
Guatemala
Contacts
CONTACTPeter Rohloff, MD PhD
PRINCIPAL_INVESTIGATORPeter Rohloff, MD PhD
Brigham and Women's Hospital
PRINCIPAL_INVESTIGATORManuel Ramirez, MD PhD
Institute of Nutrition of Central America and Panama
PRINCIPAL_INVESTIGATORDavid Flood, MD MSc
University of Michigan
Outcome results
None listed