Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT02216968
Brief 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.
Study:
NCT02216968
Study Brief:
Protocol Section:
NCT02216968