Produce Prescription for Childhood Obesity

Overseen By Ru-Jye Chuang, DrPH, M.S.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Brighter Bites participation

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

Compensation: Varies

Number of Visits: Unknown

Duration: 32 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how prescriptions for fruits and vegetables (Produce Prescription Group) can improve weight and health in children with obesity. It examines the impact on family food security, eating habits, and healthcare needs. Participants may qualify if they are patients at specific clinics in Galena Park, Texas, have a high BMI, live near the Houston Food Bank, and belong to low-income households. As an unphased trial, this study provides a unique opportunity for families to contribute to innovative research that could enhance community health and well-being.

Do I need to stop my current medications for this trial?

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 has shown that produce prescription programs are generally safe and well-tolerated. In one study, 38% of children who were initially overweight or obese reached a healthy weight after six months, suggesting the program's effectiveness without causing harm. Another study found that these programs helped participants eat more fruits and vegetables, reduced their food insecurity, and improved their self-reported health. Available data report no serious side effects from these programs. This evidence suggests that produce prescriptions are a safe way to support healthier eating habits and weight management in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the produce prescription approach for childhood obesity because it offers a fresh take on managing this condition. Unlike traditional treatments that often focus on medication or intensive lifestyle changes, this approach encourages healthier eating habits by providing prescriptions for fruits and vegetables. This method aims to make nutritious food more accessible and appealing to children, potentially leading to sustainable lifestyle changes. By shifting the focus from restriction to inclusion of healthy produce, this strategy could transform how we address obesity in kids, making healthy eating a fun and integral part of their daily lives.

What evidence suggests that the produce prescription program could be effective for childhood obesity?

This trial will compare a Produce Prescription Group with a Control Group. Research has shown that programs providing fruit and vegetable prescriptions can help children achieve healthier weights. In one study, 38% of children who were initially overweight or obese reached a healthy weight after six months. Another study found a noticeable decrease in body fat measurements for children who were overweight. These programs also increase fruit and vegetable intake among kids, especially in low-income families. However, not all studies showed significant changes in body fat, indicating that results can vary. ^{1 6 7 8 9}

Who Is on the Research Team?

Ru-Jye Chuang, DrPH, M.S.

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for children struggling with obesity. It's designed to see if giving them a 'prescription' for fruits and vegetables helps improve their weight and health, including reducing healthcare costs.

Inclusion Criteria

I can read and write in English or Spanish to fill out surveys.

Must be a patient at one of the four Legacy Community Health School-based clinics in Galena Park, Texas

BMI greater than 85th percentile

Exclusion Criteria

Currently participating in Brighter Bites

With a family member/sibling currently participating in Brighter Bites

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the produce prescription program aimed at improving weight status and obesity-related health outcomes

32 weeks

Follow-up

Participants are monitored for changes in health outcomes such as hemoglobin A1c, AST, ALT, blood pressure, BMI, and lipid panels

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control Group
• Produce Prescription Group

Trial Overview The study tests a program where some kids will get special prescriptions for produce (fruits and veggies), while others won't, to compare the effects on their health, diet behavior, home food environment, and healthcare usage.

How Is the Trial Designed?

Group I: Produce Prescription Group Experimental Treatment 1 Intervention

Group II: Control Group 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+

USDA The Gus Schumacher Nutrition Incentive Program (GusNIP)

Collaborator

Trials

1

Recruited

600+

Published Research Related to This Trial

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]

A study involving 883 children aged 2 to 18 showed that participation in a fruit and vegetable prescription program significantly increased their consumption by an average of 0.32 cups per additional clinical visit over 4 to 6 months.

The increase in consumption was equally attributed to both fruits and vegetables, suggesting that these programs can effectively enhance dietary habits among children from low-income families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Fruit and Vegetable Prescription Program on Children's Fruit and Vegetable Consumption. Ridberg, RA., Bell, JF., Merritt, KE., et al.[2020]

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]

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]

Pediatric obesity is a growing global issue, particularly affecting disadvantaged children, and is linked to serious health risks like type 2 diabetes, hypertension, and sleep apnea, stemming from poor lifestyle choices and environmental factors.

Effective interventions require a coordinated effort from governments, communities, and healthcare providers, including public education, school meal reforms, and personalized support for families, as well as new pharmacological approaches targeting appetite control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of pediatric obesity. Lee, WW.[2007]

Orlistat is currently the only FDA-approved medication for pediatric obesity, showing a reduction in body mass index (BMI) by 0.5 to 4 kg/m², although gastrointestinal side effects may limit its use.

Other medications like metformin and exenatide also show promise in reducing BMI (0.17 to 1.8 kg/m² and 1.1 to 1.7 kg/m² respectively) with generally mild side effects, suggesting that pharmacotherapy could be beneficial alongside lifestyle changes for managing severe pediatric obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological management of obesity in pediatric patients. Boland, CL., Harris, JB., Harris, KB.[2022]

In a 2-year study involving 65 overweight and obese children, those who received a multi-component family-focused education package showed a significant reduction in BMI SDS compared to those who only received body composition monitoring during the control period.

The intervention group had a greater success rate, with 33% achieving a target reduction in BMI SDS, and they gained 5.7 kg less over the study duration, indicating the effectiveness of the educational approach in managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a multi-disciplinary family-based programme for treating childhood obesity (the Family Project). Coppins, DF., Margetts, BM., Fa, JL., et al.[2015]

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]

Implementing evidence-based guidelines for childhood obesity identification and prevention in primary care significantly increased the identification of at-risk children, with a notable improvement in documentation (p < .0001).

The use of a tracking form during preventative care visits enhanced the delivery of obesity prevention education through motivational interviewing, leading to better engagement with families (p < .05).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of childhood obesity identification and prevention strategies in primary care: A quality improvement project. Rankin, A., Blood-Siegfried, J., Vorderstrasse, A., et al.[2023]

Dietary interventions for obese children can lead to relative weight loss, as indicated by meta-analyses of 37 randomized controlled trials, although the specifics of these dietary treatments are often poorly documented.

The overall effectiveness of dietary treatments for childhood obesity remains unclear due to the lack of high-quality studies and the variability in study designs and outcomes, highlighting the need for better research in this critical area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring effectiveness of dietetic interventions in child obesity: a systematic review of randomized trials. Collins, CE., Warren, J., Neve, M., et al.[2018]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11035140/

Pediatric produce prescription initiatives in the U.S. One study showed a statistically significant decrease in BMI z-score (95.6 to 73.1) in children who were classified as having overweight or ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10529680/

The Impact of Produce Prescriptions on Diet, Food Security ... The study found that produce prescription program participation was associated with improvements in F&V intake, food insecurity, and self-reported health status ...

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

Pediatric produce prescription initiatives in the U.S. To describe pediatric Produce Prescription (PRx) interventions and their study designs, outcomes, and opportunities for future research.

8. 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.

9. 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.