Brighter Bites/Legacy Produce Rx Program

Child Obesity Clinical Trial

Official title:

Brighter Bites & Legacy Community Health Produce Rx: Evaluating the Feasibility and Effectiveness of a School-based Clinical Nutrition Program With Produce Prescription

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06407284
• Other study ID #: HSC-SPH-23-0850
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Ru-Jye Chuang, DrPH, M.S.
• Phone: 713-500-9244
• Email: Ru-Jye.Chuang[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effectiveness of the produce prescription program at improving weight status and obesity-related health outcomes of participants, to examine the impacts of the program on household food insecurity and nutrition security, to examine the impacts of the program on participating adolescents' dietary behavioral outcomes, their home nutrition environment and feeding practices and to examine the impacts of the program in reducing healthcare use and associated costs

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: August 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Must be a patient at one of the four Legacy Community Health School-based clinics in Galena Park, Texas

• BMI> 85th percentile

• reside within a 10-mile radius of Houston Food Bank

• 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

Related Conditions & MeSH terms

• Child Obesity
• Pediatric Obesity

Intervention

Other:
• Produce Prescription Group
Participants will receive 16 produce bags, each containing approximately 50 servings of F&V. The produce bags will be assembled by Brighter Bites at school sites using donated produce and delivered to houses using DoorDash. F&V bags will be distributed to families every 2 weeks for 16 distributions (over approximately 32 weeks). Participants will also receive nutrition education, including MyPlate.gov's Start Simple App for adolescents, and a Virtual Culinary Medicine Program for parents; these nutrition education programs are theory-driven, tailored to diverse populations, and proven to support behavior change.
• Control Group
Participants in this group will be selected from de-identified Electronic Health Record (EHR) provided by Legacy Community Health with a 1-to-1 match to the intervention group participant's demographic characteristics and Medicaid eligibility.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	USDA The Gus Schumacher Nutrition Incentive Program (GusNIP)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body mass index (BMI)	This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.	baseline , post intervention (32 weeks after baseline)
Primary	Change in systolic blood pressure	This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.	baseline , post intervention (32 weeks after baseline)
Primary	Change in diastolic blood pressure	This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.	baseline , post intervention (32 weeks after baseline)
Primary	Change in hemoglobin A1c as assessed by blood work	This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.	baseline , post intervention (32 weeks after baseline)
Primary	Change in Aspartate transaminase (AST) assessed by blood work	This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.	baseline , post intervention (32 weeks after baseline)
Primary	Change in Alanine transaminase (ALT) assessed by blood work	This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.	baseline , post intervention (32 weeks after baseline)
Primary	Change in lipid panels assessed by blood work	This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.	baseline , post intervention (32 weeks after baseline)
Secondary	Change in household food insecurity prevalence among participants (measured as a percentage) as assessed by the two item Hunger Vital Sign screening tool	This is a 2 item questionnaire and each is categorically scored as often true, sometimes true or never true, higher number indicating higher prevalence of household food insecurity	baseline , post intervention (32 weeks after baseline)
Secondary	Change in household food insecurity as assessed by the U.S. Household Food Security Survey Module: Six-Item Short Form Economic Research Service	This is a 6 item questionnaire and raw scores range from 0-6, higher score indicating worse outcome	baseline , post intervention (32 weeks after baseline)
Secondary	Change in nutrition security as assessed by the self reported Perceived Limited Ability validated screener	This is a 4 item questionnaire, each is scored from 0-4, higher score indicating better outcome	baseline , post intervention (32 weeks after baseline)
Secondary	Change in amount of fruit and vegetable intake		baseline , post intervention (32 weeks after baseline)
Secondary	Change in amount of junk food consumed		baseline , post intervention (32 weeks after baseline)
Secondary	Change in number of times subject eats out at restaurants		baseline , post intervention (32 weeks after baseline)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Change in impact of the Produce Prescription intervention on adolescent patients' behavioral and emotional health as assessed by the Patient Health Questionnaire for Adolescents (PHQ-A)	This is a 9 item questionnaire and each is scored from 0(not at all) to 3(nearly every day), for a maximum score of 27, higher score indicating worse outcome	baseline , post intervention (32 weeks after baseline)
Secondary	Healthcare usage as assessed by the number of well-visits		post intervention (32 weeks after baseline)
Secondary	Healthcare usage as assessed by the number of visits due to illness		post intervention (32 weeks after baseline)
Secondary	Healthcare usage as assessed by the number of no shows to clinic appointments		From 6 months prior to the intervention to two months post-intervention