Obesity, Childhood
Conditions
Brief summary
The purpose of this study is to clinically evaluate the effectiveness of an at-home delivery produce prescription in improving weight status and obesity-related health outcomes and to examine the impacts of the program on child dietary behavioral outcomes (child fruit and vegetable intake, junk food consumption, and eating at any type of restaurant), and parent feeding practices (preparing foods from scratch, use of nutrition facts labels to make purchasing decisions, and eating meals with their referent child).
Interventions
Boxes of fresh fruit and vegetables (F&V), each containing approximately 50 servings of F&V, will be assembled by Brighter Bites at school sites using donated produce and delivered to houses using DoorDash. F&V boxes will be distributed to families every 2 weeks over 32 weeks. Participants will also receive nutrition education using the Brighter Bites app which includes recipes for a variety of meal types or produce types, all of which are searchable. Recipes include the average cost to prepare, the number of servings, and the calories for the recipe. The Brighter Bites app also includes healthy living Brighter Choices suggestions such as tips for how to store different types of foods, gardening tips, and tips to pack a healthy lunchbox. In addition to the Brighter Bites app, trained staff will facilitate virtual nutrition education for patient families.
OTHERStandard of care
Standard of care includes routine lab work collection and weight and diet counseling for overweight or obese children. Additionally, referrals placed to community resources for those identified with Social Determinants of Health(SDOH) needs.
Sponsors
Brighter Bites and Humana Foundation
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Must be a patient at University of Texas Physicians Greens Clinic or University of Texas Physicians Pediatric Primary Care in Houston, Texas * BMI\>85th percentile * reside within a 10-mile radius of a Brighter Bites school * Medicaid recipients or low-income uninsured * parents must be able to read and write in English or Spanish to complete surveys
Exclusion criteria
* currently participating in Brighter Bites * a family member/sibling currently participating in Brighter Bites * child is currently attending a school that offers Brighter Bites
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in levels of triglycerides in milligrams per deciliter (mg/dl) as assessed by blood work | baseline , post intervention (32 weeks after baseline) |
| Change in level of hemoglobin A1c in milligrams per deciliter (mg/dL) as assessed by blood work | baseline , post intervention (32 weeks after baseline) |
| Change in level of Aspartate transaminase (AST) in units per liter (U/L) as assessed by blood work | baseline , post intervention (32 weeks after baseline) |
| Change in level of Alanine transaminase (ALT) in units per liter (U/L) as assessed by blood work | baseline , post intervention (32 weeks after baseline) |
| Change in level of low-density lipoprotein(LDL) in milligrams per deciliter (mg/dl) as assessed by blood work | baseline , post intervention (32 weeks after baseline) |
| Change in levels of high-density lipoprotein(HDL) in milligrams per deciliter (mg/dl) as assessed by blood work | baseline , post intervention (32 weeks after baseline) |
| Change in levels of total cholesterol in milligrams per deciliter (mg/dl) as assessed by blood work | baseline , post intervention (32 weeks after baseline) |
| Change in body mass index (BMI) | baseline , post intervention (32 weeks after baseline) |
| Change in systolic blood pressure | baseline , post intervention (32 weeks after baseline) |
| Change in diastolic blood pressure | baseline , post intervention (32 weeks after baseline) |
Secondary
| Measure | Time frame |
|---|---|
| Change in amount of junk food consumed | baseline , post intervention (32 weeks after baseline) |
| Change in number of times subject eats out at restaurants | baseline , post intervention (32 weeks after baseline) |
| Change in parent feeding practices as assessed by the number of times parent has cooked food from scratch | baseline , post intervention (32 weeks after baseline) |
| Change in parent feeding practices as assessed by the number of times parent has used nutrition facts labels to make purchasing decisions | baseline , post intervention (32 weeks after baseline) |
| Change in parent feeding practices as assessed by the number of times parent has eaten meals with their referent child | baseline , post intervention (32 weeks after baseline) |
| Change in amount of fruit and vegetable intake | baseline , post intervention (32 weeks after baseline) |
Countries
United States
Outcome results
None listed