Clinical trial NCT06407284: Brighter Bites/Legacy Produce Rx Program
Official title: Brighter Bites & Legacy Community Health Produce Rx: Evaluating the Feasibility and Effectiveness of a School-based Clinical Nutrition Program With Produce Prescription
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Child Obesity
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: USDA The Gus Schumacher Nutrition Incentive Program (GusNIP)
First posted: 2024-05-09
Enrollment: 600
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* Must be a patient at one of the four Legacy Community Health School-based clinics in Galena Park, Texas
* BMI greater than or equal to 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
* patient and parents must confirm their willingness to complete the participant's well-child visit for the entire period of the study (approximately one year).

Exclusion Criteria:

* currently participating in Brighter Bites
* with a family member/sibling currently participating in 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 hemoglobin A1c as assessed by blood work
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in Aspartate transaminase (AST) assessed by blood work
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in Alanine transaminase (ALT) assessed by blood work
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in lipid panels assessed by blood work
timeFrame: baseline , post intervention (32 weeks after baseline)
Secondary outcomes:
measure: Change in household food insecurity prevalence among participants (measured as a percentage) as assessed by the two item Hunger Vital Sign screening tool
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in household food insecurity as assessed by the U.S. Household Food Security Survey Module: Six-Item Short Form Economic Research Service
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Change in nutrition security as assessed by the self reported Perceived Limited Ability validated screener
timeFrame: baseline , post intervention (32 weeks after baseline)
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)
measure: 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)
timeFrame: baseline , post intervention (32 weeks after baseline)
measure: Healthcare usage as assessed by the number of well-visits
timeFrame: post intervention (32 weeks after baseline)
measure: Healthcare usage as assessed by the number of visits due to illness
timeFrame: post intervention (32 weeks after baseline)
measure: Healthcare usage as assessed by the number of no shows to clinic appointments
timeFrame: From 6 months prior to the intervention to two months post-intervention
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: Ru-Jye Chuang, DrPH, M.S.
role: PRINCIPAL_INVESTIGATOR
References: