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

Not Applicable

Not yet recruiting

• Conditions: Obesity, Childhood
• Interventions: Other: Produce prescription program; Other: Standard of care

• Registration Number: NCT06390397
• Lead Sponsor: The University of Texas Health Science Center, Houston

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-22
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-28
• Last Update Submitted: 2024-04-28
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Primary Completion: 2025-12-22
• Study Completion: 2026-02-21

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Produce prescription program	Standard of care	-
Standard of Care	Standard of care	-
Produce prescription program	Produce prescription program	-

Primary Outcome Measures

Name	Time	Method
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 systolic blood pressure	baseline , post intervention (32 weeks after baseline)
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 body mass index (BMI)	baseline , post intervention (32 weeks after baseline)
Change in diastolic blood pressure	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)

Secondary Outcome Measures

Name	Time	Method
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)
Change in amount of junk food consumed	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 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)

Trial Locations

Locations (1)

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