Clinical trial

Brighter Bites & University of Texas Physicians Produce Rx Extension: Evaluating the Effectiveness of a Prospective Clinical Nutrition Study With Produce Prescriptions

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06390397

Active, not recruitingNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age5 Years to 12 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Childhood

Full registry criteria

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

Treatments and study arms

Produce prescription program

Other

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

Other

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.

Primary outcomes

Change in body mass index (BMI)baseline , post intervention (32 weeks after baseline)

Change in systolic blood pressurebaseline , post intervention (32 weeks after baseline)

Change in diastolic blood pressurebaseline , post intervention (32 weeks after baseline)

Change in level of hemoglobin A1c in milligrams per deciliter (mg/dL) as assessed by blood workbaseline , post intervention (32 weeks after baseline)

Change in level of Aspartate transaminase (AST) in units per liter (U/L) as assessed by blood workbaseline , post intervention (32 weeks after baseline)

Change in level of Alanine transaminase (ALT) in units per liter (U/L) as assessed by blood workbaseline , post intervention (32 weeks after baseline)

Change in level of low-density lipoprotein(LDL) in milligrams per deciliter (mg/dl) as assessed by blood workbaseline , post intervention (32 weeks after baseline)

Change in levels of high-density lipoprotein(HDL) in milligrams per deciliter (mg/dl) as assessed by blood workbaseline , post intervention (32 weeks after baseline)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

The University of Texas Health Science Center at Houston🇺🇸 Houston, Texas, United States

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