Brighter Bites & University of Texas Physicians Produce Rx Extension: Evaluating the Effectiveness of a Prospective Clinical Nutrition Study With Produce Prescriptions
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 level of hemoglobin A1c in milligrams per deciliter (mg/dL) as assessed by blood work
- Status
- Active, Not Recruiting
- Last Updated
- 9 months ago
Overview
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).
Investigators
Shreela V Sharma
Professor
The University of Texas Health Science Center, Houston
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
Outcomes
Primary Outcomes
Change in level of hemoglobin A1c in milligrams per deciliter (mg/dL) as assessed by blood work
Time Frame: 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
Time Frame: 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
Time Frame: baseline , post intervention (32 weeks after baseline)
Change in systolic blood pressure
Time Frame: baseline , post intervention (32 weeks after baseline)
Change in levels of triglycerides in milligrams per deciliter (mg/dl) as assessed by blood work
Time Frame: baseline , post intervention (32 weeks after baseline)
Change in body mass index (BMI)
Time Frame: baseline , post intervention (32 weeks after baseline)
Change in diastolic blood pressure
Time Frame: 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
Time Frame: 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
Time Frame: baseline , post intervention (32 weeks after baseline)
Change in levels of total cholesterol in milligrams per deciliter (mg/dl) as assessed by blood work
Time Frame: baseline , post intervention (32 weeks after baseline)
Secondary Outcomes
- 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))