Purpose

The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to a wait-list control group 9 months after the intervention on changes in primary child outcomes (HbA1c, and vegetable intake), on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)), and the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes.

Conditions

Eligibility

Eligible Ages
Between 6 Years and 9 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • enrollment of 100 1st, 2nd, and 3rd grade students - high proportion of children participating in the free and reduced lunch (FRL) program (>70%) - willingness to implement a coordinated school health (CSH) program

Exclusion Criteria

  • Prior participation in BB in the previous school year - children or parents identified as special needs per school; or having any physical, cognitive, or psychological disability that would prevent participation in evaluation measures

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Brighter Bites
This group will receive the Brighter Bites intervention throughout the study implementation. The intervention includes fruit and vegetable distributions of ~20lbs. for teachers and families, healthy recipe tastings, and nutrition education.
  • Other: Brighter Bites
    Families will receive a distribution of fresh fruits and vegetables (FV) (~20lbs., 50 servings/family/distribution) for ~16 weeks during the school year using primarily donated produce from local food banks. Nutrition education will be implemented for children using the evidence-based Coordinated Approach to Child Health (CATCH) program and for parents using bilingual nutrition handbooks and fun food experiences such as healthy FV recipe tastings for families during produce pick-up time will be conducted.
No Intervention
Control group
This delayed intervention group will receive the Brighter Bites intervention after concluding their participation in the study.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Shreela Sharma, PhD
713-500-9344
Shreela.V.Sharma@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Shreela Sharma, PhD
(713) 500-9344
Shreela.V.Sharma@uth.tmc.edu

Detailed Description

The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to wait-list control at post intervention on changes in primary child outcomes (HbA1c, and vegetable intake), to examine the effects of the BB intervention compared to wait-list control at 9-month post intervention on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)),to examine the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes at 9-month post-intervention, using within-subject analyses, examine and compare the long-term and dose-response effects of the BB intervention strategies on diet, adiposity, and metabolic outcomes at 21-month follow-up in the children and to explore the moderating effects of social and environmental variables on program effectiveness.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.