Combined Nutrition and Parenting Study
BUNDLE
Impact of Combined Nutrition, Responsive Parenting, and Health Intervention on Childhood Development Study
1 other identifier
interventional
2,240
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2027
Shorter than P25 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2026
CompletedFirst Posted
Study publicly available on registry
March 24, 2026
CompletedStudy Start
First participant enrolled
February 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
Study Completion
Last participant's last visit for all outcomes
June 1, 2028
March 24, 2026
March 1, 2026
1.3 years
March 10, 2026
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (27)
Child height or length-for-age z-score
7 months
Child weight-for-age z-score
7 months
Child weight-for-height (or length) z-score
7 months
Child egg consumption
7 months
Child fish consumption
7 months
- +22 more secondary outcomes
Other Outcomes (4)
Child diarrhea
7 months
Child fever
7 months
Child respiratory infection
7 months
- +1 more other outcomes
Study Arms (4)
Responsive Stimulation, female and male caregivers
EXPERIMENTALAdult 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.
Nutrition
EXPERIMENTALHouseholds 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.
Responsive stimulation + Nutrition, female and male caregivers
EXPERIMENTALThis 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.
Standard of care control
NO INTERVENTIONInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Plan International
Kakata, Liberia
Plan International
Sanniquellie, Liberia
Plan International
Tubmanburg, Liberia
Plan International
Voinjama, Liberia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leila Larson, PhD MPH
University of South Carolina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 10, 2026
First Posted
March 24, 2026
Study Start (Estimated)
February 1, 2027
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
March 24, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Final submission and release of the study data will occur approximately 12 months following the end of fieldwork and within the award period (or before the associated publication, whichever comes first). Study data deposited in DASH will be available to the research community in perpetuity. Datasets underlying methodological publications will be shared at or prior to initial publication date.
- Access Criteria
- Scientific data (sum scores, item data, scale composites, transcripts) will be preserved and shared. Respondent identifiers will not be shared. There will be no additional limitations other than the controls and privacy protections described here. DASH is a NIH controlled-access data repository. The NICHD DASH Data Access Committee reviews all requests to access DASH data from identity-verified requesters, to determine whether the proposed use is scientifically and ethically appropriate and does not conflict with constraints or research data use limitations identified by the institutions that submitted the research data. The Recipient's institution and the Recipient must sign and agree to the terms and conditions in the NICHD DASH Data Use Agreement for accessing research data.
All direct respondent identifiers (e.g., names and addresses) will be removed and maintained in a secure file. All other scientific data (sum scores, item data, scale composites) will be preserved and shared. Respondent identifiers will not be shared. Documentation to be made publicly available to the research community will include questionnaires and tools, a detailed User Guide, a codebook with univariate statistics for each variable, and study-level metadata following the Data Documentation Initiative specification. Each variable in the codebook will include a brief description of the item along with the question number and question text from the questionnaire, variable name, variable label, value labels, and standard codes for missing values-including codes for non-applicable, "don't know," and refusal. Documentation will be provided in portable document format (PDF).