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Clinical Trials/NCT05556070
NCT05556070
Completed
N/A

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

The University of Texas Health Science Center, Houston1 site in 1 country150 target enrollmentOctober 17, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity, Childhood
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
150
Locations
1
Primary Endpoint
Change in alanine aminotransferase (ALT)
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to clinically evaluate the effectiveness of an at-home produce delivery prescription or grocery store vouchers prescription at improving weight status and obesity-related health outcomes of participants across the two clinics as compared to a control group 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)

Registry
clinicaltrials.gov
Start Date
October 17, 2022
End Date
November 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christine Markham

Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

  • 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
  • with a family member/sibling currently participating in Brighter Bites
  • child is currently attending a school that offers Brighter Bites

Outcomes

Primary Outcomes

Change in alanine aminotransferase (ALT)

Time Frame: Baseline, 9 months after baseline

Change in hemoglobin A1c

Time Frame: Baseline, 9 months after baseline

Change in Aspartate transaminase (AST)

Time Frame: Baseline, 9 months after baseline

Change in Body Mass Index (BMI)

Time Frame: Baseline, 9 months after baseline

Change in systolic blood pressure

Time Frame: Baseline, 9 months after baseline

Change in Lipid panel

Time Frame: Baseline, 9 months after baseline

Change in diastolic blood pressure

Time Frame: Baseline, 9 months after baseline

Secondary Outcomes

  • Change in amount of fruit and vegetable intake(Baseline, 9 months after baseline)
  • Change in number of times subject eats out at restaurants(Baseline, 9 months after baseline)
  • Change in amount of junk food consumed(Baseline, 9 months 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, 9 months after baseline)
  • Change in parent feeding practices as assessed by the number of times parent has eaten meals with their referent child(Baseline, 9 months after baseline)
  • Change in parent feeding practices as assessed by the number of times parent has cooked food from scratch(Baseline, 9 months after baseline)

Study Sites (1)

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