Clinical Trials Directory

Trials / Completed

CompletedNCT02216968

Increasing Vegetable Intake in Children

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
600 (estimated)
Sponsor
Baylor College of Medicine · Academic / Other
Sex
All
Age
3 Years – 5 Years
Healthy volunteers
Accepted

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).

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALIncrease vegetable intake in pre-school children6-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".

Timeline

Start date
2012-07-01
Primary completion
2016-12-01
Completion
2016-12-01
First posted
2014-08-15
Last updated
2017-07-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02216968. Inclusion in this directory is not an endorsement.