Evaluating the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Child and Parents Health in a Persistent Poverty Area
NCT Number: NCT06570707
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Child Obesity|Cardiometabolic Health
Interventions: OTHER: Brighter Bites
Sponsor: The University of Texas Health Science Center, Houston
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: CHILD
Enrollment: 720
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-08
Completion Date: 2028-04-30
Locations: The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States

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 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.

Primary Outcome Measures: 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: 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)