Health Trials

Combined Nutrition and Parenting Study

ConditionEarly Childhood Development (ECD)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-30
SponsorUniversity of South Carolina

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Responsive stimulation, female and male caregivers

    Behavioral

    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

    Other intervention

    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.

Treatment groups

2,240 Participants
are divided into 4 treatment groups
Group A: Responsive Stimulation, female and male caregiversExperimental treatment 1 intervention
Group B: NutritionExperimental treatment 1 intervention
Group C: Responsive stimulation + Nutrition, female and male caregiversExperimental treatment 2 interventions
Group D: Standard of care controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
7 months
2

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.

Time frame
7 months
3

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.

Time frame
7 months
4

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.

Time frame
7 months

Secondary outcomes

1

Child height or length-for-age z-score

Change from baseline to end-line in child height or length-for-age z-score.

Time frame
7 months
2

Child weight-for-age z-score

Change from baseline to end-line in child weight-for-age z-score.

Time frame
7 months
3

Child weight-for-height (or length) z-score

Change from baseline to end-line in child weight-for-height (or length) z-score.

Time frame
7 months
4

Child egg consumption

Change from baseline to end-line in percent children consuming at least 3 eggs in the past week

Time frame
7 months

Other outcomes

1

Child diarrhea

Change from baseline to end-line in percent children with at least one diarrheal episode in the past two weeks.

Time frame
7 months
2

Child fever

Change from baseline to end-line in percent children with at least one fever in the past two weeks.

Time frame
7 months
3

Child respiratory infection

Change from baseline to end-line in percent children with at least one respiratory infection in the past two weeks.

Time frame
7 months
4

Child vomiting

Change from baseline to end-line in percent children with at least one instance of vomiting in the past two weeks.

Time frame
7 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of South Carolina

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Plan International

Collaborator

Research Institute of the McGill University Health Center

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: