Addressing the Double Burden of Malnutrition in Guatemala

NCT ID: NCT06750120

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1532 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2029-08-31

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.

Conditions

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

Keywords

Guatemala; stunting; maternal obesity; food supplementation; lifestyle counseling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Arm

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.

Group Type: EXPERIMENTAL

Enhanced Usual Care

Intervention Type: OTHER

Enhanced usual care includes

1. Usual care: free standard pregnancy, postnatal, and infant care through Ministry of Health services.

2. 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.

Family food ration

Intervention Type: DIETARY_SUPPLEMENT

Monthly household food rations providing 5 daily food groups and a mean of 165 kcal/per capita/day

Optimal weight counseling

Intervention Type: BEHAVIORAL

Counseling on health gestational weight gain and post partum weight loss

Enhanced Usual Care Arm

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: OTHER

Enhanced usual care includes

1. Usual care: free standard pregnancy, postnatal, and infant care through Ministry of Health services.

2. 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.

Interventions

Enhanced Usual Care

Enhanced usual care includes

1. Usual care: free standard pregnancy, postnatal, and infant care through Ministry of Health services.

2. 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.

Intervention Type: OTHER

Family food ration

Monthly household food rations providing 5 daily food groups and a mean of 165 kcal/per capita/day

Intervention Type: DIETARY_SUPPLEMENT

Optimal weight counseling

Counseling on health gestational weight gain and post partum weight loss

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wuqu' Kawoq, Maya Health Alliance

OTHER

Sponsor Role: collaborator

Instituto de Nutricion de Centroamerica y Panama (INCAP)

UNKNOWN

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peter J. Rohloff, M.D.,Ph.D.

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Rohloff, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Manuel Ramirez, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Nutrition of Central America and Panama

Central Contacts

Peter Rohloff, MD PhD

Role: CONTACT

Phone: 617-732-5500

Email: prohloff@bwh.harvard.edu

References

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.

Reference Type: BACKGROUND

PMID: 31852602 (View on PubMed)

Other Identifiers

2024P003339

Identifier Type: -

Identifier Source: org_study_id