Combined Nutrition and Parenting Study (BUNDLE)

University of South Carolina

Status and phase: Begins enrollment in 8 months; Phase 3

Conditions: Early Childhood Development (ECD)

Treatments: Other: Food provision and nutrition education; Behavioral: Responsive stimulation, female and male caregivers

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07490899

1R01HD116874-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study aims to evaluate whether early childhood development is improved by a bundled set of interventions that promote responsive stimulation and improved nutrition by the provision of eggs and dried fish (nutrient-dense animal source foods), and whether, in combination, these stimulation and nutrition interventions are more effective than responsive stimulation or food provision alone.

Full description

The BUNDLE study will examine the effects of a 7-month nutrition and caregiving intervention for female and male caregivers delivered by trained adult community facilitators in rural communities across Liberia. The study will use a four-arm 2x2 factorial cluster randomized design to test the effectiveness of the interventions on primary outcomes of child cognitive, language, motor, and socio-emotional development. In this study, 2240 children aged 6 to 30 months will be recruited from 160 rural communities randomized to a comparison arm or one of the three intervention arms. The comparison arm will receive the local standard of care. Three intervention arms will also receive either a responsive stimulation intervention with female and male caregivers, provision of eggs and dried fish accompanied by nutrition education, or responsive stimulation + provision of eggs and dried fish. We hypothesize that child development will be improved in all intervention arms compared to the comparison arm and in the combined intervention arm compared to the single intervention arms.

Enrollment: 2,240 estimated patients

Sex: All

Ages: 6 to 30 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Resides in selected community in Liberia
• Household has a child aged 6-30 months at study enrollment
• Child has a primary female caregiver and second (male or female) caregiver ≥ 18 years of age
• Caregivers and child intend to continue residing in the study area for the follow-up duration
• Both primary and second caregiver provide informed consent

Exclusion criteria

• Children with known allergies to eggs or fish
• Caregivers with cognitive and severe physical disabilities who are unable to implement intervention activities
• Children with developmental disabilities

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,240 participants in 4 patient groups

Responsive Stimulation, female and male caregivers

Experimental group

Description:

Adult community facilitators will facilitate peer group sessions with primary female secondary (male or female) caregivers using Plan International's adapted Responsive Caregiving curriculum. Caregivers will be encouraged to bring their children to the sessions to practice the learned activities. Facilitators will deliver key messages and allow participants to practice learned activities and provide them with feedback and encouragement. The sessions will focus on practice, problem-solving, and peer support. Sessions will be conducted fortnightly for 7 months. Each session will last approximately 60-90 minutes. Home visits will be conducted by the facilitators every 2.5 months to provide one-on-one support to the caregivers around the intervention activities.

Treatment:

Behavioral: Responsive stimulation, female and male caregivers

Nutrition

Experimental group

Description:

Households will receive weekly provisions of 7 eggs and 3 pieces of dried Bonny fish for the participating child, and an additional 3 eggs and 1 piece of fish to share. At the start of the intervention, Community Health Assistants will provide a group nutrition education session focused on the importance of feeding the child eggs and dried fish, ways to feed these foods to the child, and on infant and young child feeding more generally. This session will last 60-90 minutes. Brief nutrition messages will be reinforced when the food is delivered to households on a fortnightly basis.

Treatment:

Other: Food provision and nutrition education

Responsive stimulation + Nutrition, female and male caregivers

Experimental group

Description:

This arm is a combination of the responsive stimulation arm and the nutrition arm. Briefly, adult community facilitators will facilitate peer group sessions with primary female and secondary (male or female) caregivers using Plan International's adapted Responsive Caregiving curriculum. Households will also receive weekly provisions of 7 eggs and 3 pieces of dried Bonny fish for the participating child, and an additional 3 eggs and 1 piece of fish to share. They will also receive nutrition education.

Treatment:

Behavioral: Responsive stimulation, female and male caregivers

Other: Food provision and nutrition education

Standard of care control

No Intervention group