Child ObesityNCT06407284
Brighter Bites/Legacy Produce Rx Program
A study testing Produce Prescription Group in people with Child Obesity, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Child Obesity
- What is being tested?
- Produce Prescription Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- currently participating in Brighter Bites
- with a family member/sibling currently participating in Brighter Bites
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mallika Mathur contact
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Ru-Jye Chuang, DrPH, M.S., 713-500-9244, Ru-Jye.Chuang@uth.tmc.edu
Mallika Mathur, Mallika.Mathur@uth.tmc.edu
About this study
Official title: Brighter Bites & Legacy Community Health Produce Rx: Evaluating the Feasibility and Effectiveness of a School-based Clinical Nutrition Program With Produce Prescription
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
- Conditions
- Child Obesity
- Being tested
- Produce Prescription Group, Control Group
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Produce Prescription GroupOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Produce Prescription Group | Experimental | Not described Receives: Other: Produce Prescription Group |
| Control Group | Active comparator | Not described Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline , post intervention (32 weeks after baseline)
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.
Measured: baseline , post intervention (32 weeks after baseline)
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.
Measured: baseline , post intervention (32 weeks after baseline)
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.
Measured: baseline , post intervention (32 weeks after baseline)
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.
Measured: baseline , post intervention (32 weeks after baseline)
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.
Measured: baseline , post intervention (32 weeks after baseline)
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.
Measured: baseline , post intervention (32 weeks after baseline)
Secondary outcomes (13)
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
Measured: baseline , post intervention (32 weeks after baseline)
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
Measured: baseline , post intervention (32 weeks after baseline)
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
Measured: baseline , post intervention (32 weeks after baseline)
Change in amount of fruit and vegetable intake
Measured: baseline , post intervention (32 weeks after baseline)
Change in amount of junk food consumed
Measured: baseline , post intervention (32 weeks after baseline)
Change in number of times subject eats out at restaurants
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
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
Measured: baseline , post intervention (32 weeks after baseline)
Healthcare usage as assessed by the number of well-visits
Measured: post intervention (32 weeks after baseline)
Healthcare usage as assessed by the number of visits due to illness
Measured: post intervention (32 weeks after baseline)
Healthcare usage as assessed by the number of no shows to clinic appointments
Measured: From 6 months prior to the intervention to two months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start15 Jan 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- USDA The Gus Schumacher Nutrition Incentive Program (GusNIP)
- Responsible party
- Principal investigator, Ru-Jye Chuang, The University of Texas Health Science Center, Houston
- Investigators
- Ru-Jye Chuang, DrPH, M.S., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407284
- Sponsor's protocol ID
- HSC-SPH-23-0850
- Status last verified
- Jan 2025
- First submitted
- 6 May 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brighter Bites & Legacy Community Health Produce Rx: Evaluating the Feasibility and Effectiveness of a School-based Clinical Nutrition Program With Produce Prescription
- ClinicalTrials.gov ID
- NCT06407284
- Acronym / sponsor ID
- HSC-SPH-23-0850
- Conditions
- Child Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- USDA The Gus Schumacher Nutrition Incentive Program (GusNIP)
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Produce Prescription Group | Experimental | Other: Produce Prescription Group |
| Control Group | Active comparator | Other: Control Group |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- currently participating in Brighter Bites
- with a family member/sibling currently participating in Brighter Bites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Produce Prescription GroupParticipants 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. | Other | Produce Prescription Group |
| Control GroupParticipants 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. | Other | Control Group |
Primary outcome
Change in body mass index (BMI)
Time frame: 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 systolic blood pressure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
13 secondary outcomes
Change in household food insecurity prevalence among participants (measured as a percentage) as assessed by the two item Hunger Vital Sign screening tool
Time frame: baseline , post intervention (32 weeks after baseline)
Change in household food insecurity as assessed by the U.S. Household Food Security Survey Module: Six-Item Short Form Economic Research Service
Time frame: baseline , post intervention (32 weeks after baseline)
Change in nutrition security as assessed by the self reported Perceived Limited Ability validated screener
Time frame: baseline , post intervention (32 weeks after baseline)
Change in amount of fruit and vegetable intake
Time frame: baseline , post intervention (32 weeks after baseline)
Change in amount of junk food consumed
Time frame: baseline , post intervention (32 weeks after baseline)
Change in number of times subject eats out at restaurants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: baseline , post intervention (32 weeks after baseline)
Healthcare usage as assessed by the number of well-visits
Time frame: post intervention (32 weeks after baseline)
Healthcare usage as assessed by the number of visits due to illness
Time frame: post intervention (32 weeks after baseline)
Healthcare usage as assessed by the number of no shows to clinic appointments
Time frame: From 6 months prior to the intervention to two months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Child Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
Not yet recruiting
Weight Gain in Pediatric Leukemia Survivors
Leukemia, Pediatric Acute Lymphoblastic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mallika Mathur contact
Ru-Jye Chuang, DrPH, M.S. principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Produce Prescription Group in people with Child Obesity, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ru-Jye Chuang, DrPH, M.S. (713-500-9244, Ru-Jye.Chuang@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass index (BMI) (time frame: baseline , post intervention (32 weeks after baseline)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.