Produce Prescriptions for Childhood Obesity

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MM
Overseen ByMallika Mathur
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a special produce delivery program, the Produce Prescription Program, can help children with obesity eat healthier and improve their weight and overall health. It compares children using the produce program to those receiving regular care to determine who benefits more. Eligible participants must be patients at specific clinics in Houston, have a BMI above the 85th percentile (indicating higher weight for their height), live near a designated school, and be on Medicaid or low-income uninsured. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance health outcomes for children with obesity.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that programs providing fruits and vegetables to children are generally well-received. Studies have found that these programs can improve health, such as better weight and heart health, by increasing fruit and vegetable consumption among kids. No reports of problems or safety issues have been directly linked to these programs, indicating that participation is safe for children. These programs aim to boost fruit and vegetable intake, benefiting children's overall health.12345

Why are researchers excited about this trial?

Researchers are excited about the Produce Prescription Program for childhood obesity because it offers a fresh approach by providing families with prescriptions for fruits and vegetables. Unlike traditional treatments for childhood obesity, which often focus on medication or calorie restriction, this program empowers families to access healthier food options directly. By promoting dietary changes and improving access to nutritious produce, this initiative aims to tackle obesity at its root, potentially leading to sustainable and healthy lifestyle changes for children.

What evidence suggests that the Produce Prescription Program could be effective for childhood obesity?

Research has shown that programs providing fruit and vegetable prescriptions can improve the health of children dealing with obesity. In this trial, participants may receive the Produce Prescription Program, designed to increase fruit and vegetable consumption. One study found that 38% of overweight or obese children reached a healthy weight after six months in such a program. These programs also appear to increase fruit and vegetable consumption, especially in low-income families. However, some studies did not find significant changes in BMI (a measure of body fat based on height and weight) for children. Overall, these programs may help improve diet quality and access to healthy food, which are important for managing obesity.12367

Who Is on the Research Team?

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Shreela Sharma, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for children with obesity. It's designed to see if getting fresh produce delivered at home can help improve their weight and health related to obesity. The study also looks at how this program affects kids' eating habits, like how much fruits and veggies they eat, junk food intake, and dining out frequency, as well as parents' food preparation practices.

Inclusion Criteria

Reside within a 10-mile radius of a Brighter Bites school
Must be a patient at University of Texas Physicians Greens Clinic or University of Texas Physicians Pediatric Primary Care in Houston, Texas
BMI greater than the 85th percentile
See 2 more

Exclusion Criteria

A family member/sibling currently participating in Brighter Bites
Currently participating in Brighter Bites
Child is currently attending a school that offers Brighter Bites

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an at-home delivery produce prescription to improve weight status and obesity-related health outcomes

12 weeks

Follow-up

Participants are monitored for changes in dietary behaviors and health outcomes after the treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Produce Prescription Program
Trial Overview The trial is testing a 'produce prescription program,' where families receive fresh fruits and vegetables at home against the standard care usually given for childhood obesity. Researchers will monitor changes in the children's weight status, dietary behaviors, and parental feeding practices to determine effectiveness.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Produce prescription programExperimental Treatment2 Interventions
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Brighter Bites and Humana Foundation

Collaborator

Trials
1
Recruited
150+

Published Research Related to This Trial

The Parks Rx 4Health(TM) program in Miami-Dade County connects pediatricians with community-based health initiatives, allowing doctors to refer overweight and obese children to an evidence-based afterschool program focused on physical activity and nutrition.
This program collects measurable outcomes like body mass index and fitness levels at baseline and after 3 and 6 months, providing valuable data to track patient progress and support ongoing healthcare efforts against childhood obesity.
Reducing childhood obesity through coordinated care: Development of a park prescription program.Messiah, SE., Jiang, S., Kardys, J., et al.[2020]
The US medical system currently struggles to effectively address childhood obesity, with primary care practices often not aligning with evidence-based recommendations for prevention and treatment.
Collaboration between childhood obesity specialists and primary care providers has shown promise in improving the quality of care for obesity prevention and treatment, highlighting the importance of systematic approaches to tackle this issue.
Building capacity for childhood obesity prevention and treatment in the medical community: call to action.Haemer, M., Cluett, S., Hassink, SG., et al.[2022]
Customizing electronic medical records (EMR) with evidence-based guidelines significantly improved the documentation of body mass index (BMI) and the diagnosis of overweight and obesity in children aged 7 to 18 years.
Despite the increase in diagnosis rates following EMR customization, the overall rates of obesity diagnosis still remain lower than the actual prevalence in the community, indicating a need for further improvement in screening practices.
Childhood obesity: Can electronic medical records customized with clinical practice guidelines improve screening and diagnosis?Saviñon, C., Taylor, JS., Canty-Mitchell, J., et al.[2018]

Citations

Impact of a Fruit and Vegetable Prescription Program on ...Among children who were initially overweight or obese, 38% achieved a healthy weight after 6 mo. These findings suggest that produce prescription programs can ...
Pediatric produce prescription initiatives in the U.S.Pediatric PRx interventions show promising potential to reduce FI and improve diet quality and health-related outcomes.
Impact of Produce Prescriptions on Diet, Food Security ...No significant changes in BMI z-score were observed (−0.01 [−0.06 to 0.04]) after program participation for children. Sensitivity Analyses.
Design and protocol of a clinic-based comparative ...The purpose of this study is to clinically evaluate and compare the feasibility and preliminary effectiveness of two different produce prescription strategies ( ...
Effect of a Fruit and Vegetable Prescription Program on ...Fruit and vegetable prescription programs in clinical settings may increase fruit and vegetable consumption among children in low-income households.
Impact of a Fruit and Vegetable Prescription Program on ...The Navajo FVRx program improves fruit and vegetable consumption among young children. Children who are obese or overweight may benefit most from the program.
Impact of Produce Prescriptions on Diet, Food Security ...Produce prescription programs can improve health outcomes in adults with risk factors for and conditions such as diabetes, hypertension, and obesity.
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