Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06570707

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 9 Years

SexAll

Healthy volunteersNot accepted

ConditionChild Obesity, Cardiometabolic Health

Full registry 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

Treatments and study arms

Brighter Bites

Other

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.

Primary outcomes

Change in level of child Glycosylated hemoglobin (HbA1c)baseline, post intervention (9 months after baseline)

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

Change in amount of child vegetable intake as assessed by the VEGGIE METER®baseline, post intervention (9 months after baseline)

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.

Study locations

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The University of Texas Health Science Center at Houston🇺🇸 Houston, Texas, United States

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Shreela Sharma, PhDContact

Email · Call 713-500-9344

Emily AdlparvarContact

Email · Call (713) 500 9608