Produce Prescriptions for Childhood Obesity

Overseen By Mallika Mathur

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Currently in Brighter Bites, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

Who Is on the Research Team?

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

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?

Group I: Produce prescription program Experimental Treatment 2 Interventions

Group II: Standard of Care Active Control 1 Intervention

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The Fruit and Vegetable Prescription Program (FVPP) in Michigan aims to improve children's diet, food security, and weight status by providing $15 prescriptions for fresh produce at pediatric clinic visits, with a total of 700 caregiver-child pairs enrolled for a two-year study.

The study will compare the effects of varying levels of exposure to the FVPP among children aged 8-16, assessing changes in their dietary habits and health outcomes, which will help determine the program's effectiveness and the necessary duration of exposure for significant impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a pediatric fruit and vegetable prescription program on child dietary patterns, food security, and weight status: a study protocol. Saxe-Custack, A., Todem, D., Anthony, JC., et al.[2022]

Participation in a six-month produce prescription program significantly improved food security and reduced diastolic blood pressure among participants, with 122 graduates primarily from underserved communities in Georgia.

The program combined nutrition education with subsidies for fresh produce, demonstrating its potential effectiveness in enhancing health outcomes for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food Security and Clinical Outcomes of the 2017 Georgia Fruit and Vegetable Prescription Program. Cook, M., Ward, R., Newman, T., et al.[2021]

Health care providers involved in produce prescription projects reported operational challenges such as time constraints, difficulties in engaging patients, and barriers to data sharing, which were exacerbated by the COVID-19 pandemic.

Despite these challenges, providers expressed satisfaction with the projects due to positive patient outcomes, including improved food security and clinical results, highlighting the need for dedicated staff and rigorous program evaluation to ensure sustainability and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Produce prescription projects: Challenges, solutions, and emerging best practices - Perspectives from health care providers. Stotz, SA., Budd Nugent, N., Ridberg, R., et al.[2022]

This study involves 150 low-income children aged 5-12 years, focusing on the effectiveness of two produce prescription strategies—home delivery and grocery store vouchers—on improving obesity-related health outcomes.

The trial will measure various health indicators, including BMI z-scores and blood pressure, to assess the impact of these interventions, alongside nutrition education, on dietary behaviors and overall health in the pediatric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and protocol of a clinic-based comparative effectiveness randomized controlled trial to determine the feasibility and effectiveness of food prescription program strategies in at-risk pediatric populations. Mathur, M., Marshall, A., Yeragi, P., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7377262/

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 ...

2.

nature.com

nature.com/articles/s41390-023-02920-8

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.

3.

ahajournals.org

ahajournals.org/doi/10.1161/CIRCOUTCOMES.122.009520

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.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714423003026

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 ( ...

5.

cdc.gov

cdc.gov/pcd/issues/2019/18_0555.htm

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.

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2475299122120469

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.

7.

chcs.org

chcs.org/resource-center-item/impact-of-produce-prescriptions-on-diet-food-security-and-cardiometabolic-health-outcomes-a-multisite-evaluation-of-9-produce-prescription-programs-in-the-united-states/

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.