Brighter Bites/Legacy Produce Rx Program
ConditionChild Obesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorThe University of Texas Health Science Center, Houston
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
currently participating in Brighter Bites
with a family member/sibling currently participating in Brighter Bites
Trial design
Design model
Parallel
Treatments tested in this trial
Produce Prescription Group
Other interventionParticipants 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
Other interventionParticipants 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Produce Prescription GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline , post intervention (32 weeks after baseline)2
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.
Time frame
baseline , post intervention (32 weeks after baseline)3
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.
Time frame
baseline , post intervention (32 weeks after baseline)4
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.
Time frame
baseline , post intervention (32 weeks after baseline)Secondary outcomes
1
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
Time frame
baseline , post intervention (32 weeks after baseline)2
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
Time frame
baseline , post intervention (32 weeks after baseline)3
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
Time frame
baseline , post intervention (32 weeks after baseline)4
Change in amount of fruit and vegetable intake
Time frame
baseline , post intervention (32 weeks after baseline)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center, Houston
Lead sponsor
USDA The Gus Schumacher Nutrition Incentive Program (GusNIP)
Collaborator
Source ClinicalTrials.gov
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