Combined Nutrition and Parenting Study (BUNDLE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Early Childhood Development (ECD)
• Intervention / Treatment: Behavioral: Responsive stimulation, female and male caregivers; Other: Food provision and nutrition education

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.

• Study Type: Interventional
• Enrollment (Estimated): 2240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Leila Larson, PhD MPH; Phone Number: 803-576-5649; Email: larsonl@mailbox.sc.edu
• Study Contact Backup: Name: Edward Frongillo, PhD; Email: leilamlarson@gmail.com

Study Locations

• Liberia
  • Kakata, Liberia
    • Plan International
    • Contact: Leila Larson, PhD MPH; Phone Number: 803-576-5649; Email: larsonl@mailbox.sc.edu
  • Sanniquellie, Liberia
    • Plan International
    • Contact: Leila Larson, PhD MPH; Phone Number: 803-576-5649; Email: larsonl@mailbox.sc.edu
  • Tubmanburg, Liberia
    • Plan International
    • Contact: Leila Larson, PhD MPH; Phone Number: 803-576-5649; Email: larsonl@mailbox.sc.edu
  • Voinjama, Liberia
    • Plan International
    • Contact: Leila Larson, PhD MPH; Phone Number: 803-576-5649; Email: larsonl@mailbox.sc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Responsive 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 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.	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.
Experimental: Nutrition; 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.	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.
Experimental: Responsive 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 additional 3 eggs and 1 piece of fish to share. They will also receive nutrition education.	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.
No Intervention: Standard of care control

What is the study measuring?

Primary 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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child diarrhea	Change from baseline to end-line in percent children with at least one diarrheal episode in the past two weeks.	7 months
Child fever	Change from baseline to end-line in percent children with at least one fever in the past two weeks.	7 months
Child respiratory infection	Change from baseline to end-line in percent children with at least one respiratory infection in the past two weeks.	7 months
Child vomiting	Change from baseline to end-line in percent children with at least one instance of vomiting in the past two weeks.	7 months

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Research Institute of the McGill University Health Center; Plan International
• Investigators: Principal Investigator: Leila Larson, PhD MPH, University of South Carolina

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: nutrition; early childhood development; cluster randomized trial; responsive caregiving; animal source food
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Measurements; Nutrition Assessment
• Other Study ID Numbers: 1R01HD116874-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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).

IPD Sharing 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.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No