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Clinical Trial NCT07490899 (BUNDLE) for Early Childhood Development (ECD) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University of South CarolinaCombined Nutrition and Parenting Study (BUNDLE) Phase 3 2,240
Clinical Trial NCT07490899 (BUNDLE) is designed to study Prevention for Early Childhood Development (ECD). This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 1 February 2027 until the study accrues 2,240 participants. Led by University of South Carolina, this study is expected to complete by 1 June 2028. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
Brief 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...Show More
Official Title
Impact of Combined Nutrition, Responsive Parenting, and Health Intervention on Childhood Development Study
Conditions
Early Childhood Development (ECD)Other Study IDs
NCT ID Number
Start Date (Actual)
2027-02
Last Update Posted
2026-03-24
Completion Date (Estimated)
2028-06
Enrollment (Estimated)
2,240
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Keywords
cluster randomized trial
responsive caregiving
nutrition
early childhood development
animal source food
responsive caregiving
nutrition
early childhood development
animal source food
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalResponsive Stimulation, female and male caregivers 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 feedbac...Show More | 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. |
ExperimentalNutrition 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 fee...Show More | 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. |
ExperimentalResponsive stimulation + Nutrition, female and male caregivers 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 additi...Show More | 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. 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. |
No InterventionStandard of care control | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Cognitive Development | Change from baseline to end-line in cognitive composite score on Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 162 with higher scores representing higher cognitive development. | 7 months |
Language Development | Change from baseline to end-line in language composite score on the Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 158 with higher scores representing higher language development. | 7 months |
Motor Development | Change from baseline to end-line in motor composite score on the Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 208 with higher scores representing higher motor development. | 7 months |
Socio-emotional Development | Change from baseline to end-line in socio-emotional score on the Wolke Behavior Rating scale. Scores range from 9 to 81 with higher scores representing higher socio-emotional development. | 7 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Child height or length-for-age z-score | Change from baseline to end-line in child height or length-for-age z-score. | 7 months |
Child weight-for-age z-score | Change from baseline to end-line in child weight-for-age z-score. | 7 months |
Child weight-for-height (or length) z-score | Change from baseline to end-line in child weight-for-height (or length) z-score. | 7 months |
Child egg consumption | Change from baseline to end-line in percent children consuming at least 3 eggs in the past week | 7 months |
Child fish consumption | Change from baseline to end-line in percent children consuming at least 1 piece of fish in the past week | 7 months |
Child dietary diversity | Change from baseline to end-line in child dietary diversity score defined as number of food groups out of a total of eight food groups consumed in the previous 7 days based on World Health Organization guidelines and is assessed in children aged six months or older. | 7 months |
Responsive feeding | Change from baseline to end-line in responsive feeding score assessed using the responsive feeding assessment. Scores range from 8 to 32 with higher scores representing higher responsive feeding behaviors. | 7 months |
Early learning opportunities | Change from baseline to end-line in early learning opportunities score assessed using the Tool for Early learning. Scores range from 0 to 14 with higher scores representing more opportunities for early learning. | 7 months |
Primary female caregiver social support | Change from baseline to end-line in primary female caregiver perceived social support assessed using the Multidimensional Scale of Perceived Social Support. Scores range from 12 to 84 with higher scores representing higher social support. | 7 months |
Primary female caregiver responsive caregiver-child interactions | Change from baseline to end-line in proportion of responsive interactions between the primary female caregiver and child assessed using the Tool for Responsive Care. | 7 months |
Male caregiver responsive caregiver-child interactions | Change from baseline to end-line in proportion of responsive interactions between the male caregiver and child assessed using the Tool for Responsive Care. | 7 months |
Secondary female caregiver responsive caregiver-child interactions | Change from baseline to end-line in proportion of responsive interactions between the secondary female caregiver and child assessed using the Tool for Responsive Care. | 7 months |
Primary female caregiver depression | Change from baseline to end-line in the primary female caregiver depression score assessed using the Patient Health Questionnaire-9. Scores range from 0 to 27 with higher scores representing higher depressive symptoms. | 7 months |
Male caregiver depression | Change from baseline to end-line in the male caregiver depression score assessed using the Patient Health Questionnaire-9. Scores range from 0 to 27 with higher scores representing higher depressive symptoms. | 7 months |
Secondary female caregiver depression | Change from baseline to end-line in the secondary female caregiver depression score assessed using the Patient Health Questionnaire-9. Scores range from 0 to 27 with higher scores representing higher depressive symptoms. | 7 months |
Primary female caregiver anxiety | Change from baseline to end-line in the primary female caregiver anxiety score assessed using the General Anxiety Disorder-7 Questionnaire. Scores range from 0 to 21 with higher scores representing higher anxiety. | 7 months |
Male caregiver anxiety | Change from baseline to end-line in the male caregiver anxiety score assessed using the General Anxiety Disorder-7 Questionnaire. Scores range from 0 to 21 with higher scores representing higher anxiety. | 7 months |
Secondary female caregiver anxiety | Change from baseline to end-line in the secondary female caregiver anxiety score assessed using the General Anxiety Disorder-7 Questionnaire. Scores range from 0 to 21 with higher scores representing higher anxiety. | 7 months |
Primary female caregiver positive mental health | Change from baseline to end-line in the primary caregiver positive mental health score assessed using the Mental Health Continuum-Short Form. Scores range from 14 to 84 with higher scores representing poorer mental health. | 7 months |
Male caregiver positive mental health | Change from baseline to end-line in the male caregiver positive mental health score assessed using the Mental Health Continuum-Short Form. Scores range from 14 to 84 with higher scores representing poorer mental health. | 7 months |
Secondary female caregiver positive mental health | Change from baseline to end-line in the secondary female caregiver positive mental health score assessed using the Mental Health Continuum-Short Form. Scores range from 14 to 84 with higher scores representing poorer mental health. | 7 months |
Primary female caregiver stress | Change from baseline to end-line in the primary female caregiver perceived stress score assessed using the Parenting Stress Index. Scores range from 36 to 147 with higher scores representing higher stress. | 7 months |
Male caregiver stress | Change from baseline to end-line in the male caregiver perceived stress score assessed using the Parenting Stress Index. Scores range from 36 to 147 with higher scores representing higher stress. | 7 months |
Secondary female caregiver stress | Change from baseline to end-line in the secondary female caregiver perceived stress score assessed using the Parenting Stress Index. Scores range from 36 to 147 with higher scores representing higher stress. | 7 months |
Primary female caregiver Co-parenting | Change from baseline to end-line in the primary female co-parenting score assessed using the brief Coparenting Relationship Scale. Scores range from 0 to 84 with higher scores representing more positive coparenting. | 7 months |
Male caregiver Co-parenting | Change from baseline to end-line in the male caregiver co-parenting score assessed using the brief Coparenting Relationship Scale. Scores range from 0 to 84 with higher scores representing more positive coparenting. | 7 months |
Secondary female caregiver Co-parenting | Change from baseline to end-line in the secondary female caregiver co-parenting score assessed using the brief Coparenting Relationship Scale. Scores range from 0 to 84 with higher scores representing more positive coparenting. | 7 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
6 Months
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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
- 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
University of South Carolina301 active studies to exploreStudy Responsible Party
Leila Larson, Principal Investigator, Assistant Professor, University of South Carolina
Study Central Contact
Contact: Leila Larson, PhD MPH, 803-576-5649, [email protected]
Contact: Edward Frongillo, PhD, [email protected]
4 Study Locations in 1 Countries
Plan International, Kakata, Liberia
Leila Larson, PhD MPH, Contact, 803-576-5649, [email protected]
Plan International, Sanniquellie, Liberia
Leila Larson, PhD MPH, Contact, 803-576-5649, [email protected]
Plan International, Tubmanburg, Liberia
Leila Larson, PhD MPH, Contact, 803-576-5649, [email protected]
Plan International, Voinjama, Liberia
Leila Larson, PhD MPH, Contact, 803-576-5649, [email protected]