Clinical trial NCT06570707: Evaluating the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Child and Parents Health in a Persistent Poverty Area
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Obesity
Cardiometabolic Health
Keywords: Brighter Bites
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-08-26
Enrollment: 720
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in level of child Glycosylated hemoglobin (HbA1c)
timeFrame: baseline, post intervention (9 months after baseline)
measure: Change in amount of child vegetable intake as assessed by the VEGGIE METER®
timeFrame: baseline, post intervention (9 months after baseline)
Secondary outcomes:
measure: Change in household food security status as assessed by a parent survey
timeFrame: baseline, post intervention (9 months after baseline)
measure: 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.
timeFrame: baseline, post intervention (9 months after baseline)
measure: 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
timeFrame: baseline, post intervention (9 months after baseline)
measure: Child systolic blood pressure
timeFrame: baseline
measure: Child systolic blood pressure
timeFrame: Post intervention (9 months after baseline)
measure: Child diastolic blood pressure
timeFrame: baseline
measure: Child diastolic blood pressure
timeFrame: post intervention (9 months after baseline)
measure: Change in home access/availability of fruits and vegetables as assessed by the Nutrition security measures questionnaire
timeFrame: baseline, post intervention (9 months after baseline)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Shreela Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
References: