Clinical trial NCT05556070: Brighter Bites & UT Physicians Produce Rx Program
Official title: Brighter Bites & University of Texas Physicians Produce Rx: Evaluating the Effectiveness of a Prospective Clinical Nutrition Study With Produce Prescriptions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Brighter Bites
First posted: 2022-09-27
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, 9 months after baseline
measure: Change in systolic blood pressure
timeFrame: Baseline, 9 months after baseline
measure: Change in diastolic blood pressure
timeFrame: Baseline, 9 months after baseline
measure: Change in hemoglobin A1c
timeFrame: Baseline, 9 months after baseline
measure: Change in Aspartate transaminase (AST)
timeFrame: Baseline, 9 months after baseline
measure: Change in alanine aminotransferase (ALT)
timeFrame: Baseline, 9 months after baseline
measure: Change in Lipid panel
timeFrame: Baseline, 9 months after baseline
Secondary outcomes:
measure: Change in amount of fruit and vegetable intake
timeFrame: Baseline, 9 months after baseline
measure: Change in amount of junk food consumed
timeFrame: Baseline, 9 months after baseline
measure: Change in number of times subject eats out at restaurants
timeFrame: Baseline, 9 months after baseline
measure: Change in parent feeding practices as assessed by the number of times parent has cooked food from scratch
timeFrame: Baseline, 9 months after baseline
measure: Change in parent feeding practices as assessed by the number of times parent has used nutrition facts labels to make purchasing decisions
timeFrame: Baseline, 9 months after baseline
measure: Change in parent feeding practices as assessed by the number of times parent has eaten meals with their referent child
timeFrame: Baseline, 9 months after baseline
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Christine Markham, PhD
role: PRINCIPAL_INVESTIGATOR
References: