Obesity, ChildhoodNCT05556070
Brighter Bites & UT Physicians Produce Rx Program
A study testing Arm 1, Arm 2 and Arm 3 in people with Obesity, Childhood, 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 clinically evaluate the effectiveness of an at-home produce delivery prescription or grocery store vouchers prescription at improving weight status and obesity-related health outcomes of participants across the two clinics as compared to a control group and to examine the impacts of the… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Arm 1, Arm 2 and Arm 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2022to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- reside within a 10-mile radius of a Brighter Bites school
- Medicaid recipients or low-income uninsured
- parents must be able to read and write in English or Spanish to complete surveys
Who cannot join
- currently participating in Brighter Bites
- with a family member/sibling currently participating in Brighter Bites
- child is currently attending a school that offers Brighter Bites
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Brighter Bites & University of Texas Physicians Produce Rx: Evaluating the Effectiveness of a Prospective Clinical Nutrition Study With Produce Prescriptions
The purpose of this study is to clinically evaluate the effectiveness of an at-home produce delivery prescription or grocery store vouchers prescription at improving weight status and obesity-related health outcomes of participants across the two clinics as compared to a control group and to examine the impacts of the program on child dietary behavioral outcomes (child fruit and vegetable intake, junk food consumption, and eating at any type of restaurant), and parent feeding practices (preparing foods from scratch, use of nutrition facts labels to make purchasing decisions, and eating meals with their referent child)
- Conditions
- Obesity, Childhood
- Being tested
- Arm 1, Arm 2, Arm 3, Brighter Bites app
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1Other
: Local retailer produce vouchers ($25 value) will be distributed to the families biweekly over a 32-week period for a total of 16 vouchers. The vouchers can be redeemed for fresh produce at the grocery store that issued the vouchers.
Arm 2Other
Boxes of fresh fruits and vegetables (F\&V), each containing approximately 50 servings of F\&V, will be assembled by Brighter Bites at school sites using donated produce and delivered to houses using DoorDash. F\&V boxes will be distributed to families every 2 weeks over 32 weeks.
Arm 3Other
subjects in this arm will receive the usual standard of care at the clinic for the study period
Brighter Bites appOther
Participants in Arms 1 and 2 will also receive nutrition education using the Brighter Bites app which includes recipes for a variety of meal types or produce types, all of which are searchable. Recipes include the average cost to prepare, the number of servings, and the calories for the recipe. The Brighter Bites app also includes healthy living "Brighter Choices" suggestions such as tips for how to store different types of foods, gardening tips, and tips to pack a healthy lunchbox. In addition to the Brighter Bites app, trained staff will facilitate virtual nutrition education for patient families.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Other: Arm 1; Other: Brighter Bites app |
| Arm 2 | Experimental | Not described Receives: Other: Arm 2; Other: Brighter Bites app |
| Arm 3 | Active comparator | Not described Receives: Other: Arm 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI)
Measured: Baseline, 9 months after baseline
Change in systolic blood pressure
Measured: Baseline, 9 months after baseline
Change in diastolic blood pressure
Measured: Baseline, 9 months after baseline
Change in hemoglobin A1c
Measured: Baseline, 9 months after baseline
Change in Aspartate transaminase (AST)
Measured: Baseline, 9 months after baseline
Change in alanine aminotransferase (ALT)
Measured: Baseline, 9 months after baseline
Change in Lipid panel
Measured: Baseline, 9 months after baseline
Secondary outcomes (6)
Change in amount of fruit and vegetable intake
Measured: Baseline, 9 months after baseline
Change in amount of junk food consumed
Measured: Baseline, 9 months after baseline
Change in number of times subject eats out at restaurants
Measured: Baseline, 9 months after baseline
Change in parent feeding practices as assessed by the number of times parent has cooked food from scratch
Measured: Baseline, 9 months 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, 9 months after baseline
Change in parent feeding practices as assessed by the number of times parent has eaten meals with their referent child
Measured: Baseline, 9 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start17 Oct 2022
- Primary completion31 Jul 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Brighter Bites
- Responsible party
- Principal investigator, Christine Markham, The University of Texas Health Science Center, Houston
- Investigators
- Christine Markham, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556070
- Sponsor's protocol ID
- HSC-SPH-22-0629
- Status last verified
- Dec 2024
- First submitted
- 22 Sep 2022
- Last updated
- 6 Dec 2024
- 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brighter Bites & University of Texas Physicians Produce Rx: Evaluating the Effectiveness of a Prospective Clinical Nutrition Study With Produce Prescriptions
- ClinicalTrials.gov ID
- NCT05556070
- Acronym / sponsor ID
- HSC-SPH-22-0629
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Brighter Bites
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 27 Sep 2022 (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 clinically evaluate the effectiveness of an at-home produce delivery prescription or grocery store vouchers prescription at improving weight status and obesity-related health outcomes of participants across the two clinics as compared to a control group and to examine the impacts of the program on child dietary behavioral outcomes (child fruit and vegetable intake, junk food consumption, and eating at any type of restaurant), and parent feeding practices (preparing foods from scratch, use of nutrition facts labels to make purchasing decisions, and eating meals with their referent child)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Arm 1, Other: Brighter Bites app |
| Arm 2 | Experimental | Other: Arm 2, Other: Brighter Bites app |
| Arm 3 | Active comparator | Other: Arm 3 |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- reside within a 10-mile radius of a Brighter Bites school
- Medicaid recipients or low-income uninsured
- parents must be able to read and write in English or Spanish to complete surveys
Key exclusion criteria (3 listed)
- currently participating in Brighter Bites
- with a family member/sibling currently participating in Brighter Bites
- child is currently attending a school that offers 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 |
|---|---|---|
| Arm 1: Local retailer produce vouchers ($25 value) will be distributed to the families biweekly over a 32-week period for a total of 16 vouchers. The vouchers can be redeemed for fresh produce at the grocery store that issued the vouchers. | Other | Arm 1 |
| Arm 2Boxes of fresh fruits and vegetables (F\&V), each containing approximately 50 servings of F\&V, will be assembled by Brighter Bites at school sites using donated produce and delivered to houses using DoorDash. F\&V boxes will be distributed to families every 2 weeks over 32 weeks. | Other | Arm 2 |
| Arm 3subjects in this arm will receive the usual standard of care at the clinic for the study period | Other | Arm 3 |
| Brighter Bites appParticipants in Arms 1 and 2 will also receive nutrition education using the Brighter Bites app which includes recipes for a variety of meal types or produce types, all of which are searchable. Recipes include the average cost to prepare, the number of servings, and the calories for the recipe. The Brighter Bites app also includes healthy living "Brighter Choices" suggestions such as tips for how to store different types of foods, gardening tips, and tips to pack a healthy lunchbox. In addition to the Brighter Bites app, trained staff will facilitate virtual nutrition education for patient families. | Other | Arm 1, Arm 2 |
Primary outcome
Change in Body Mass Index (BMI)
Time frame: Baseline, 9 months after baseline
Change in systolic blood pressure
Time frame: Baseline, 9 months after baseline
Change in diastolic blood pressure
Time frame: Baseline, 9 months after baseline
Change in hemoglobin A1c
Time frame: Baseline, 9 months after baseline
Change in Aspartate transaminase (AST)
Time frame: Baseline, 9 months after baseline
Change in alanine aminotransferase (ALT)
Time frame: Baseline, 9 months after baseline
Change in Lipid panel
Time frame: Baseline, 9 months after baseline
6 secondary outcomes
Change in amount of fruit and vegetable intake
Time frame: Baseline, 9 months after baseline
Change in amount of junk food consumed
Time frame: Baseline, 9 months after baseline
Change in number of times subject eats out at restaurants
Time frame: Baseline, 9 months after baseline
Change in parent feeding practices as assessed by the number of times parent has cooked food from scratch
Time frame: Baseline, 9 months 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, 9 months 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, 9 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Christine Markham, PhD 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 Arm 1, Arm 2 and Arm 3 in people with Obesity, Childhood, 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 6 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) (time frame: Baseline, 9 months 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 6 Dec 2024.