Combined Nutrition and Parenting Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Responsive stimulation, female and male caregivers, Food provision and nutrition education.
- Who it may be relevant to
- Registry conditions: Early Childhood Development (ECD). Basic parameters: 6 months — 30 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Liberia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Combined Nutrition, Responsive Parenting, and Health Intervention on Childhood Development Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Cognitive Development [Time frame: 7 months]
- Language Development [Time frame: 7 months]
- Motor Development [Time frame: 7 months]
- Socio-emotional Development [Time frame: 7 months]
Secondary outcome measures (12)
- Child height or length-for-age z-score [Time frame: 7 months]
- Child weight-for-age z-score [Time frame: 7 months]
- Child weight-for-height (or length) z-score [Time frame: 7 months]
- Child egg consumption [Time frame: 7 months]
- Child fish consumption [Time frame: 7 months]
- Child dietary diversity [Time frame: 7 months]
- Responsive feeding [Time frame: 7 months]
- Early learning opportunities [Time frame: 7 months]
- Primary female caregiver social support [Time frame: 7 months]
- Primary female caregiver responsive caregiver-child interactions [Time frame: 7 months]
- Male caregiver responsive caregiver-child interactions [Time frame: 7 months]
- Secondary female caregiver responsive caregiver-child interactions [Time frame: 7 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Liberia · 4 centers
- Plan International — Kakata
- Plan International — Sanniquellie
- Plan International — Tubmanburg
- Plan International — Voinjama
Identifiers
NCT: NCT07490899 · 1R01HD116874-01 · 1R01HD116874-01