An interventional study of Produce prescription program and Standard of care in Obesity, Childhood, sponsored by The University of Texas Health Science Center, Houston. Active, not recruiting at 1 site in United States. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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).
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's planned enrollment of 150 is above the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Produce prescription program · Other: Standard of care
Other: Standard of care
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.
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.
Change in body mass index (BMI)
Time frame: baseline , post intervention (32 weeks after baseline)
Change in systolic blood pressure
Time frame: baseline , post intervention (32 weeks after baseline)
Change in diastolic blood pressure
Time frame: baseline , post intervention (32 weeks after baseline)
Change in level of hemoglobin A1c in milligrams per deciliter (mg/dL) as assessed by blood work
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline , post intervention (32 weeks after baseline)
Change in levels of total cholesterol in milligrams per deciliter (mg/dl) as assessed by blood work
Time frame: baseline , post intervention (32 weeks after baseline)
Change in levels of triglycerides in milligrams per deciliter (mg/dl) as assessed by blood work
Time frame: baseline , post intervention (32 weeks after baseline)
Change in amount of fruit and vegetable intake
Time frame: baseline , post intervention (32 weeks after baseline)
Change in amount of junk food consumed
Time frame: baseline , post intervention (32 weeks after baseline)
Change in number of times subject eats out at restaurants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline , post intervention (32 weeks after baseline)
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston