Evaluating the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Child and Parents Health in a Persistent Poverty Area
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brighter Bites.
- Who it may be relevant to
- Registry conditions: Child Obesity, Cardiometabolic Health. Basic parameters: 6 years — 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Interventions
- 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 b
Primary outcome measures
- Change in level of child Glycosylated hemoglobin (HbA1c) [Time frame: baseline, post intervention (9 months after baseline)]
- Change in amount of child vegetable intake as assessed by the VEGGIE METER® [Time frame: baseline, post intervention (9 months after baseline)]
Secondary outcome measures (8)
- Change in household food security status as assessed by a parent survey [Time frame: 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. [Time frame: 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 [Time frame: baseline, post intervention (9 months after baseline)]
- Child systolic blood pressure [Time frame: baseline]
- Child systolic blood pressure [Time frame: Post intervention (9 months after baseline)]
- Child diastolic blood pressure [Time frame: baseline]
- Child diastolic blood pressure [Time frame: post intervention (9 months after baseline)]
- Change in home access/availability of fruits and vegetables as assessed by the Nutrition security measures questionnaire [Time frame: baseline, post intervention (9 months after baseline)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
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 2 PMID 42229798
Identifiers
NCT: NCT06570707 · HSC-SPH-23-0282 · 5U54CA280804-02