Addressing the Double Burden of Malnutrition in Guatemala
- Conditions
- Maternal Obesity Complicating Pregnancy, Birth,or PuerperiumChild Malnutrition
- Registration Number
- NCT06750120
- Lead Sponsor
- Brigham and Women's Hospital
- 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. In this study, we will evaluate how a combined intervention including both counseling for healthy weight in mothers and food supplementation for families can reduce the double burden of malnutrition in rural Guatemala.
- Detailed Description
Globally, populations are experiencing increases in diseases attributable to overnutrition, but child undernutrition also persists at high levels. This "double burden of malnutrition" commonly appears as maternal overweight/obesity and child stunting in the same household. Poor nutrition during the critical life stages of the pregnancy, the postpartum period, and early childhood increases life-long risk for nutrition-related non-communicable diseases such as diabetes, hypertension, and dyslipidemia for both mother and child. Evidence-based interventions exist that promote optimal weight gain during pregnancy and postpartum weight loss or prevent undernutrition among children, but little is known about implementing them as integrated, scalable, intergenerational, affordable, and equity-focused solutions. The overall goal of this project is to assess the effectiveness, implementation, and cost-effectiveness of an integrated intervention to reduce the double burden of malnutrition among pregnant/postpartum women and their children. We will conduct a type 1 hybrid effectiveness-implementation trial in rural Guatemalan Indigenous communities that have among the world's highest prevalence of the double burden of malnutrition. Our project will have three parts. In Part 1, we will conduct an individually randomized hybrid type 1 effectiveness-implementation trial with 766 pregnant mothers and their children, including both food supplementation and counselling to optimize mothers' gestational weight gain and limit postpartum weight retention. Our primary evaluation will focus on maternal weight and child length at 12 months after birth. In Part 2, we will assess barriers and facilitators to implementation of the integrated DBM intervention and develop strategies to promote widespread implementation. In Part 3, we will conduct an economic evaluation on the integrated nutrition intervention. To our knowledge, this aim will generate the first evidence of costs and cost-effectiveness of interventions to address DBM at the household level, providing crucial information to policymakers and stakeholders for future implementation and budgeting. Overall, this project will generate globally relevant implementation evidence on interventions for the double burden of malnutrition. Results will have implications for nutrition and NCD policy not only in Guatemala but also globally. A major feature of the project is a focus on pragmatism and equity, working to enroll the most vulnerable families from rural Guatemala who stand most to benefit from the intervention but who are commonly excluded from clinical trials.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 1532
- Pregnant women < 28 weeks gestation,
- aged >=16years
- subject willing and able to provide informed consent
- Prior self-reported history of pre-eclampsia, gestational or pregestational diabetes
- >= 28 weeks gestation at enrollment visit
- Gestational or pregestational diabetes will be defined by self-report or hemoglobin A1c (HbA1c) ≥6.5% at enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Maternal weight 12 months post partum Difference in mean maternal weight (kg) between arms at 12 mo. postpartum
Infant length for age Z score 12 months post partum Between group difference in mean child lengthforage z score at 12 mo. using WHO growth standards.
- Secondary Outcome Measures
Name Time Method Adequacy of maternal gestational weight gain 1 Month preceding delivery Difference in initial and final pregnancy weight using IOM cut points, means compared between arms. Prepregnancy BMI will be estimated using self-reported prepregnancy weight and enrollment height.
Postpartum maternal waist to hip ratio 6 and 12 month postpartum Difference in waist to hip ratio between arms at 6 and 12 mo. postpartum
Maternal physical activity 12 months postpartum Global Physical Activity Questionnaire. Means compared between arms.
Maternal dietary diversity 36 weeks gestation and 12 months postpartum Minimum Dietary Diversity for Women tool,which is a validated proxy measure of micronutrient adequacy among cohorts of reproductive-age women. Proportions compared between arms
Household food insecurity 36 weeks gestation and 12 months postpartum Food Insecurity Experience Scale. Means compared between arms
Maternal Hemoglobin 12 months postpartum WHO anemia cut points will be adjusted for elevation. Proportion of anemia compared between arms.
Maternal health-related quality of life 36 weeks gestation and 12 months postpartum WHOQOL-BREF tool; means compared between arms.
Neonatal and infant mortality 12 months postpartum Adjudicated by study staff using facility records and/or verbal autopsy. Final rates compared between arms at study exit (12 mo post partum).
Infant hemoglobin 12 months of age WHO anemia cut points will be adjusted for elevation. Proportion of anemia compared between arms.
Global child development 12 months of age Caregiver Reported Early Child Development Instruments (CREDI) long form, which has been validated in Indigenous populations in Guatemala. Mean age-adjusted Z scores compared between arms
Related Research Topics
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