Evaluating the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Child and Parents Health in a Persistent Poverty Area

Cluster-Randomized Controlled Trial (RCT) to Evaluate the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Health of Children and Parents in a Persistent Poverty Area

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.

Study Overview

• Status: Recruiting
• Conditions: Child Obesity; Cardiometabolic Health
• Intervention / Treatment: Other: Brighter Bites

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.

• Study Type: Interventional
• Enrollment (Estimated): 720
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shreela Sharma, PhD; Phone Number: (713) 500-9344; Email: Shreela.V.Sharma@uth.tmc.edu
• Study Contact Backup: Name: Emily Adlparvar; Phone Number: (713) 500 9608; Email: Emily.M.Adlparvar@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Shreela Sharma, PhD; Phone Number: 713-500-9344; Email: Shreela.V.Sharma@uth.tmc.edu
      • Contact: Emily Adlparvar; Phone Number: (713) 500 9608; Email: Emily.M.Adlparvar@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in level of child Glycosylated hemoglobin (HbA1c)	We will utilize the portable HbA1c analyzers (DCA Vantage analyzer) to assess HbA1c, during biometric events.	baseline, post intervention (9 months after baseline)
Change in amount of child vegetable intake as assessed by the VEGGIE METER®	The VEGGIE METER® is used to obtain a child's quantitative metric of skin carotenoids, a proxy measure of FV intake for children. The VEGGIE METER® measures skin carotenoids as an indicator of FV intake. Higher number of carotenoid levels indicate more FV intake.	baseline, post intervention (9 months after baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in household food security status as assessed by a parent survey	Household Food Insecurity will be measured using 2-item Hunger Vital Sign food security survey and 4-items adapted from the Center for Nutrition and Health Impact, for a total of 6-items. The items are scored from 0 (if the participant selects "Always") to 4 (if the participant selects "Never") and the measure's score is the mean of the responses. The higher the participant's score, the greater degree of the household nutrition security.	baseline, post intervention (9 months after baseline)
Number of servings consumed by the parent as assessed by the Adapted Health of Houston Survey (HHS) on processed food/drinks 4-items, and fruit and vegetable intake 2 items.	This is a 6-item questionnaire. The parent responds the number of servings they consumed during the time period. Servings are calculated based on the servings per day.	baseline, post intervention (9 months after baseline)
Number of servings consumed by the Child as assessed by the NIH's Eating at America's Table questionnaire (All Day) and the Dietary Screener Questionnaires	This is a 6-item questionnaire. The parent responds the number of servings their child consumed during the time period. Servings are calculated based on the servings per day.	baseline, post intervention (9 months after baseline)
Child systolic blood pressure	Child's systolic blood pressure will be obtained with an automatic cuff according to recommendations of the American Heart Association. This will be measure during biometric events.	baseline
Child systolic blood pressure	Child's systolic blood pressure will be obtained with an automatic cuff. This will be measure during biometric events.	Post intervention (9 months after baseline)
Child diastolic blood pressure	Child's diastolic blood pressure will be obtained with an automatic cuff. This will be measure during biometric events.	baseline
Child diastolic blood pressure	Child's diastolic blood pressure will be obtained with an automatic cuff. This will be measure during biometric events.	post intervention (9 months after baseline)
Change in home access/availability of fruits and vegetables as assessed by the Nutrition security measures questionnaire	Nutrition security measures assess factors associated with a household's ability to obtain foods that meet their nutritional and health needs. Household Food Insecurity will be measured using 2-item Hunger Vital Sign food security survey and 4-items adapted from the Center for Nutrition and Health Impact, for a total of 6-items. The items are scored from 0 (if the participant selects "Always") to 4 (if the participant selects "Never") and the measure's score is the mean of the responses. The higher the participant's score, the greater degree of the household nutrition security.	baseline, post intervention (9 months after baseline)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Shreela Sharma, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Brighter Bites
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: HSC-SPH-23-0282; 5U54CA280804-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No