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Child ObesityNCT06570707

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

A study testing Brighter Bites in people with Child Obesity and Cardiometabolic Health, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 6 to 9 years
Conditions the study is for
Child Obesity, Cardiometabolic Health
What is being tested?
Brighter Bites
Could I receive a placebo?
No, everyone receives an active treatment
How many people
720 participants
Where
1 siteUnited States
Study dates
8 Aug 2024to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shreela Sharma, PhD contact

(713) 500-9344

Shreela.V.Sharma@uth.tmc.edu

Emily Adlparvar contact

(713) 500 9608

Emily.M.Adlparvar@uth.tmc.edu

United States1 site, 1 recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

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

    Emily Adlparvar, (713) 500 9608, Emily.M.Adlparvar@uth.tmc.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Brighter Bites
Keywords
Brighter Bites
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brighter BitesOther

    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.

Study groups in NCT06570707
Study groupRoleWhat they receive
Brighter BitesExperimentalThis 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.
Receives: Other: Brighter Bites
Control groupNo interventionThis delayed intervention group will receive the Brighter Bites intervention after concluding their participation in the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in level of child Glycosylated hemoglobin (HbA1c)

    We will utilize the portable HbA1c analyzers (DCA Vantage analyzer) to assess HbA1c, during biometric events.

    Measured: baseline, post intervention (9 months after baseline)

  2. 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.

    Measured: baseline, post intervention (9 months after baseline)

Secondary outcomes (8)

  1. 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.

    Measured: baseline, post intervention (9 months after baseline)

  2. 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.

    Measured: baseline, post intervention (9 months after baseline)

  3. 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.

    Measured: baseline, post intervention (9 months after baseline)

  4. 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.

    Measured: baseline

  5. Child systolic blood pressure

    Child's systolic blood pressure will be obtained with an automatic cuff. This will be measure during biometric events.

    Measured: Post intervention (9 months after baseline)

  6. Child diastolic blood pressure

    Child's diastolic blood pressure will be obtained with an automatic cuff. This will be measure during biometric events.

    Measured: baseline

  7. Child diastolic blood pressure

    Child's diastolic blood pressure will be obtained with an automatic cuff. This will be measure during biometric events.

    Measured: post intervention (9 months after baseline)

  8. 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.

    Measured: baseline, post intervention (9 months after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start8 Aug 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
720 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06570707
Sponsor's protocol ID
HSC-SPH-23-0282
Other IDs
5U54CA280804-02
Status last verified
Jul 2025
First submitted
31 Jul 2024
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sharma S, Senn M, Chuang RJ, Perkison WB, Crichlow K, Markham C, Ramphul R, Shete S, Basen-Engquist K, McNeill L, Rechis R. Design for a cluster randomized controlled trial 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. Contemp Clin Trials. 2026 Aug;167:108361. doi: 10.1016/j.cct.2026.108361. Epub 2026 Jun 1.

    PubMed 42229798

Questions about this trial

What is this clinical trial studying?

A study testing Brighter Bites in people with Child Obesity and Cardiometabolic Health, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shreela Sharma, PhD ((713) 500-9344, Shreela.V.Sharma@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in level of child Glycosylated hemoglobin (HbA1c) (time frame: baseline, post intervention (9 months after baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06570707, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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