Addressing the Double Burden of Malnutrition in Guatemala

Mass General Brigham

Status: Begins enrollment in 3 months

Conditions: Child Malnutrition; Maternal Obesity Complicating Pregnancy, Birth,or Puerperium

Treatments: Other: Enhanced Usual Care; Behavioral: Optimal weight counseling; Dietary Supplement: Family food ration

Study type: Interventional

Funder types: Other

Identifiers

NCT06750120

2024P003339

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,532 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,532 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Two intervention components will be provided from enrollment through 12 months postpartum: 1. Monthly household food rations providing 5 daily food groups and a mean of 165 kcal/per capita/day 2. Behavioral counselling by frontline health workers to promote healthy gestational weight gain and post partum weight loss. Participants will also receive enhanced usual care as described for the active comparator arm.

Treatment:

Dietary Supplement: Family food ration

Behavioral: Optimal weight counseling

Other: Enhanced Usual Care

Enhanced Usual Care Arm

Active Comparator group

Description:

The comparator will be enhanced usual care alone, which will include: Usual care: free standard pregnancy, postnatal, and infant care through Ministry of Health services. Enhancements to usual care: Participants in both arms will be enrolled in Maya Health Alliance's free care navigation program. In this program, navigators accompany patients to clinical visits at national hospitals, provide interpretation, and cover emergency transportation cost.

Treatment:

Other: Enhanced Usual Care