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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02216968
Other study ID # H-30554
Secondary ID 1R21HD073608-01A
Status Completed
Phase N/A
First received August 6, 2014
Last updated July 11, 2017
Start date July 2012
Est. completion date December 2016

Study information

Verified date July 2017
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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".

Locations

Country Name City State
United States Baylor College of Medicine Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
Baylor College of Medicine Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vegetable Intake in Preschool Children There will be 2 phases to program development: diagnostic and formative. The diagnostic phase will consist of 20 individual interviews with child-care providers and parents (½ AA, ½ HA) and 20 interviews with preschool children (½ AA, ½ HA).In addition the parents will be asked to complete the Cooking Confidence Questionnaire, the Barriers and Facilitators Questionnaire on Vegetables and a list of their child's favorite vegetables before coming to the interview. Implementation will include the showing of the 4 video-taped puppet shows to 10-12 children immediately prior to the lunch meal on 4 consecutive days. These children will be assessed at lunch using the digital diet estimation method. 1 year 11 months
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