NCT02726529

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
710

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

March 24, 2016

Last Update Submit

March 31, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • change in intake of grams of sugar for the child as assessed using the parent-reported food frequency questionnaire

    baseline to 16 weeks

  • change in intake of grams of fat for the child as assessed using the parent-reported food frequency questionnaire

    baseline to 16 weeks

  • change in intake of servings of fruits and vegetables for the parent as assessed using the parent-reported food frequency questionnaire

    baseline to 16 weeks

  • change in availability of fruits and vegetables in the home as assessed using parent-reported surveys

    baseline to 16 weeks

Study Arms (2)

Brighter Bites

EXPERIMENTAL

Children of families in the intervention group will also receive the Coordinated Approach to Child Health (CATCH) school-based curriculum in addition to families receiving fresh fruits and vegetables to take home from school once a week along with nutrition education for 8 weeks in Fall and 8 weeks in Spring semesters of the school year.

Behavioral: Brighter BitesBehavioral: CATCH

Comparison

ACTIVE COMPARATOR
Behavioral: CATCH

Interventions

Brighter BitesBEHAVIORAL
Brighter Bites
CATCHBEHAVIORAL

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

Brighter BitesComparison

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shreela Sharma, PhD, RD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 24, 2016

First Posted

April 1, 2016

Study Start

August 1, 2013

Primary Completion

June 1, 2015

Last Updated

April 1, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations