Increasing Vegetable Intake in Children
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|
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).
|Intervention model||single group assignment|
|Masking||single blind (subject)|
Vegetable Intake in Preschool Children
time frame: 1 year 11 months
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
|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.|
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