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
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Child Obesity
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 720
- Locations
- 1
- Primary Endpoint
- Change in level of child Glycosylated hemoglobin (HbA1c)
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief 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.
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.
Investigators
Shreela V Sharma
Professor
The University of Texas Health Science Center, Houston
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
Outcomes
Primary Outcomes
Change in level of child Glycosylated hemoglobin (HbA1c)
Time Frame: 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®
Time Frame: 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.
Secondary Outcomes
- Change in household food security status as assessed by a parent survey(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(baseline, post intervention (9 months after baseline))
- Child diastolic blood pressure(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.(baseline, post intervention (9 months after baseline))
- Child systolic blood pressure(Post intervention (9 months after baseline))
- Change in home access/availability of fruits and vegetables as assessed by the Nutrition security measures questionnaire(baseline, post intervention (9 months after baseline))