Clinical trial NCT06390397: Brighter Bites & University of Texas Physicians Produce Rx Extension: Evaluating the Effectiveness of a Prospective Clinical Nutrition Study With Produce Prescriptions
Official title: Brighter Bites & University of Texas Physicians Produce Rx Extension: Evaluating the Effectiveness of a Prospective Clinical Nutrition Study With Produce Prescriptions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Brighter Bites and Humana Foundation
First posted: 2024-04-30
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 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).


Eligibility 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

Primary outcomes:
measure: Change in body mass index (BMI)
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in systolic blood pressure
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in diastolic blood pressure
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in level of hemoglobin A1c in milligrams per deciliter (mg/dL) as assessed by blood work
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in level of Aspartate transaminase (AST) in units per liter (U/L) as assessed by blood work
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in level of Alanine transaminase (ALT) in units per liter (U/L) as assessed by blood work
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in level of low-density lipoprotein(LDL) in milligrams per deciliter (mg/dl) as assessed by blood work
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in levels of high-density lipoprotein(HDL) in milligrams per deciliter (mg/dl) as assessed by blood work
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in levels of total cholesterol in milligrams per deciliter (mg/dl) as assessed by blood work
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in levels of triglycerides in milligrams per deciliter (mg/dl) as assessed by blood work
timeFrame: baseline , post intervention (32 weeks after baseline)
Secondary outcomes:
measure: Change in amount of fruit and vegetable intake
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in amount of junk food consumed
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in number of times subject eats out at restaurants
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in parent feeding practices as assessed by the number of times parent has cooked food from scratch
timeFrame: baseline , post intervention (32 weeks 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 , post intervention (32 weeks 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 , post intervention (32 weeks 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: Shreela Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
References: