NCT07490899

Combined Nutrition and Parenting Study

Impact of Combined Nutrition, Responsive Parenting, and Health Intervention on Childhood Development Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,240 (estimated)
• Sponsor: University of South Carolina · Academic / Other
• Sex: All
• Age: 6 Months – 30 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Early Childhood Development (ECD)

Interventions

Type	Name	Description
BEHAVIORAL	Responsive stimulation, female and male caregivers	Caregiving-related social and behavior change (SBC) messages and activities for primary female and secondary (male or female) caregivers focused on responsive stimulation, encompassing responsive caregiver-child interactions and the provision of early learning opportunities.
OTHER	Food provision and nutrition education	Provision of eggs and dried Bonny fish. Nutrition-related social and behavior change (SBC) messages focused on infant and young child feeding (IYCF), the importance of feeding the child eggs and dried fish, and ways to feed these foods to the child.

Timeline

• Start date: 2027-02-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

4 sites across 1 country: Liberia