Clinical trial NCT06750120: Addressing the Double Burden of Malnutrition in Guatemala
Official title: An Integrated Intervention to Address the Double Burden of Malnutrition in Guatemala
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Maternal Obesity Complicating Pregnancy, Birth,or Puerperium
Child Malnutrition
Keywords: Guatemala
stunting
maternal obesity
food supplementation
lifestyle counseling
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Wuqu' Kawoq, Maya Health Alliance
name: Instituto de Nutricion de Centroamerica y Panama (INCAP)
name: University of Michigan
name: Harvard Medical School (HMS and HSDM)
First posted: 2024-12-27
Enrollment: 1532
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women \< 28 weeks gestation,
* aged \>=16years
* subject willing and able to provide informed consent

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Maternal weight
timeFrame: 12 months post partum
measure: Infant length for age Z score
timeFrame: 12 months post partum
Secondary outcomes:
measure: Adequacy of maternal gestational weight gain
timeFrame: 1 Month preceding delivery
measure: Postpartum maternal waist to hip ratio
timeFrame: 6 and 12 month postpartum
measure: Maternal physical activity
timeFrame: 12 months postpartum
measure: Maternal dietary diversity
timeFrame: 36 weeks gestation and 12 months postpartum
measure: Household food insecurity
timeFrame: 36 weeks gestation and 12 months postpartum
measure: Maternal Hemoglobin
timeFrame: 12 months postpartum
measure: Maternal health-related quality of life
timeFrame: 36 weeks gestation and 12 months postpartum
measure: Neonatal and infant mortality
timeFrame: 12 months postpartum
measure: Infant hemoglobin
timeFrame: 12 months of age
measure: Global child development
timeFrame: 12 months of age
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Peter Rohloff, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Nutrition of Central America and Panama
name: Manuel Ramirez, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Popkin BM, Corvalan C, Grummer-Strawn LM. Dynamics of the double burden of malnutrition and the changing nutrition reality. Lancet. 2020 Jan 4;395(10217):65-74. doi: 10.1016/S0140-6736(19)32497-3. Epub 2019 Dec 15.