Overview

This trial is active, not recruiting.

Conditions obesity, behavior, food habits
Treatment increase vegetable intake in pre-school children
Sponsor Baylor College of Medicine
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date July 2012
End date December 2016
Trial size 600 participants
Trial identifier NCT02216968, 1R21HD073608-01A1, H-30554

Summary

The purpose of this study is to test the feasibility of an innovative approach to increase the amount of vegetable's (V) intake consumed by preschool children who are predominately African-American (AA) and Hispanic-American (HA).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking single blind (subject)
Arm
(Experimental)
60 African-American (AA) preschool children will participate in the Intervention Group. 60 AA children will belong to the Control Group. 6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate "increase vegetable intake in pre-school children".
increase vegetable intake in pre-school children
6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate "increase vegetable intake in pre-school children".
(Experimental)
60 Hispanic-American (HA) preschool children will participate in the Intervention Group. 60 HA children will belong to the Control Group. 6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate "increase vegetable intake in pre-school children".
increase vegetable intake in pre-school children
6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate "increase vegetable intake in pre-school children".

Primary Outcomes

Measure
Vegetable Intake in Preschool Children
time frame: 1 year 11 months

Eligibility Criteria

Male or female participants from 3 years up to 5 years old.

Inclusion Criteria: - Healthy - non-patient - normals - African-american - Hispanic-american - 3 to 5 y olds Exclusion Criteria: - pregnant woman - neonates - dietary restrictions - chronic disease - developmental disabilities - special education - does not read or write in spanish or english

Additional Information

Official title Increasing Vegetable Intake in Children
Principal investigator Theresa A Nicklas, DrPH
Description The purpose of this study is to test the feasibility of an innovative approach to increase the amount of vegetable's (V) intake consumed by preschool children who are predominately African-American (AA) and Hispanic-American (HA).The primary endpoint will be changes in V consumption in high school children with the hypothesis that a puppet intervention will increase their V consumption by preschool children. To achieve the project goal, our specific aims (SA) are to: SA1: Successfully recruit 6 preschool (PS) centers and 168 AA and 168 HA children 3 to 5 y enrolled there. SA2: Conduct individual interviews for formative assessment of the PUPPET shows. SA3: Develop the manual of operation and intervention protocols SA4: Develop 4 videotaped theatre-based PUPPET shows that are developmentally and cognitively appropriate for use with 3- to 5-year-old AA and HA children SA5: Pilot-test the feasibility of the PUPPET intervention with 3 intervention and 3 control HS centers. SA6: Use the data collected in Aim 5 to estimate parameters required to conduct a group randomized trial for an evaluation of the efficacy of the intervention. The primary hypothesis (H1) to be tested is that children who receive the PUPPET intervention will demonstrate increased V consumption in HS compared to children in the control group.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.