Brighter Bites/Legacy Produce Rx Program
- Conditions
- Child Obesity
- Interventions
- Other: Produce Prescription GroupOther: Control Group
- Registration Number
- NCT06407284
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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).
- currently participating in Brighter Bites
- with a family member/sibling currently participating in Brighter Bites
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Produce Prescription Group Produce Prescription Group - Control Group Control Group -
- Primary Outcome Measures
Name Time Method Change in systolic blood pressure baseline , post intervention (32 weeks after baseline) 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.
Change in hemoglobin A1c as assessed by blood work baseline , post intervention (32 weeks after baseline) 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.
Change in body mass index (BMI) baseline , post intervention (32 weeks after baseline) 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.
Change in lipid panels assessed by blood work baseline , post intervention (32 weeks after baseline) 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.
Change in diastolic blood pressure baseline , post intervention (32 weeks after baseline) 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.
Change in Aspartate transaminase (AST) assessed by blood work baseline , post intervention (32 weeks after baseline) 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.
Change in Alanine transaminase (ALT) assessed by blood work baseline , post intervention (32 weeks after baseline) 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.
- Secondary Outcome Measures
Name Time Method Change in household food insecurity as assessed by the U.S. Household Food Security Survey Module: Six-Item Short Form Economic Research Service baseline , post intervention (32 weeks after baseline) This is a 6 item questionnaire and raw scores range from 0-6, higher score indicating worse outcome
Change in nutrition security as assessed by the self reported Perceived Limited Ability validated screener baseline , post intervention (32 weeks after baseline) This is a 4 item questionnaire, each is scored from 0-4, higher score indicating better outcome
Change in number of times subject eats out at restaurants baseline , post intervention (32 weeks after baseline) Change in amount of junk food consumed baseline , post intervention (32 weeks after baseline) Healthcare usage as assessed by the number of well-visits post intervention (32 weeks after baseline) 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 Change in amount of fruit and vegetable intake 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) Healthcare usage as assessed by the number of visits due to illness post intervention (32 weeks after baseline) Change in household food insecurity prevalence among participants (measured as a percentage) as assessed by the two item Hunger Vital Sign screening tool baseline , post intervention (32 weeks after baseline) 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
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) 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 impact of the Produce Prescription intervention on adolescent patients' behavioral and emotional health as assessed by the Patient Health Questionnaire for Adolescents (PHQ-A) baseline , post intervention (32 weeks after baseline) 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
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States