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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02726529
Other study ID # HSC-SPH-12-0480
Secondary ID
Status Completed
Phase N/A
First received March 24, 2016
Last updated March 31, 2016
Start date August 2013

Study information

Verified date March 2016
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of the research is to find out how well a new nutrition program works for elementary school students and their families. This program is called Brighter Bites. Brighter Bites is a school-based program that teaches students and their parents about the importance of eating fresh fruits and vegetables and how to prepare them in tasty, healthy ways. This project is being carried out at six elementary schools in Houston, Texas. Up to 600 first grade students and their parents/guardians are expected to join this project.


Recruitment information / eligibility

Status Completed
Enrollment 710
Est. completion date
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 7 Years
Eligibility Inclusion Criteria:

- Child is in enrolled in the 1st grade in the participating school

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Brighter Bites

CATCH
The comparison schools received training in implementing the Coordinated Approach to Child Health (CATCH) school-based health promotion program

Locations

Country Name City State
United States University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary change intake of servings of fruits and vegetables for the child as assessed using the parent-reported food frequency questionnaire Child dietary intake was measured using the parent-reported Block Kids Food validated screener to assess children's intake by food group, with outcomes measured in number of servings. The focus of this tool is on intake of fruit and fruit juices, vegetables, potatoes (including French fries), whole grains, meat/poultry/fish, dairy, legumes, saturated fat, "added sugars" (in sweetened cereals, soft drinks, and sweets). A secondary analysis produces estimates for intake of sugary beverages (both kcal and frequency). Individual portion sizes are asked. This screener takes about 10-12 minutes to complete. Servings of fruits and vegetables consumed are cumulatively reported. baseline to 16 weeks No
Secondary change in intake of grams of sugar for the child as assessed using the parent-reported food frequency questionnaire Child dietary intake was measured using the parent-reported Block Kids Food validated screener to assess children's intake by food group, with outcomes measured in number of servings. The focus of this tool is on intake of fruit and fruit juices, vegetables, potatoes (including French fries), whole grains, meat/poultry/fish, dairy, legumes, saturated fat, "added sugars" (in sweetened cereals, soft drinks, and sweets). A secondary analysis produces estimates for intake of sugary beverages (both kcal and frequency). Individual portion sizes are asked. This screener takes about 10-12 minutes to complete. baseline to 16 weeks No
Secondary change in intake of grams of fat for the child as assessed using the parent-reported food frequency questionnaire Child dietary intake was measured using the parent-reported Block Kids Food validated screener to assess children's intake by food group, with outcomes measured in number of servings. The focus of this tool is on intake of fruit and fruit juices, vegetables, potatoes (including French fries), whole grains, meat/poultry/fish, dairy, legumes, saturated fat, "added sugars" (in sweetened cereals, soft drinks, and sweets). A secondary analysis produces estimates for intake of sugary beverages (both kcal and frequency). Individual portion sizes are asked. This screener takes about 10-12 minutes to complete. baseline to 16 weeks No
Secondary change in intake of servings of fruits and vegetables for the parent as assessed using the parent-reported food frequency questionnaire The validated 10-item Fruits and Vegetables Screener by the National Institutes of Health was administered to parents to determine the total number of servings of fruits and vegetables consumed daily. baseline to 16 weeks No
Secondary change in availability of fruits and vegetables in the home as assessed using parent-reported surveys Parents completed a self-report survey measuring frequency of availability of fresh fruits and vegetables at meals and snacks at home during the past 7 days. baseline to 16 weeks No
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