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

600 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the Produce Prescription treatment for childhood obesity?

Research shows that implementing evidence-based guidelines in primary care can significantly improve the identification and prevention of childhood obesity, which suggests that structured interventions like the Produce Prescription treatment could be effective in promoting healthier lifestyles and reducing obesity risk factors in children. ^{1 2 3 4 5}

Is the Produce Prescription for Childhood Obesity safe for children?

The research articles reviewed do not provide specific safety data for the Produce Prescription for Childhood Obesity. They focus on pharmacological treatments and general issues related to pediatric obesity, but do not address the safety of produce prescriptions. ^{1 6 7 8 9}

How is the Produce Prescription treatment for childhood obesity different from other treatments?

The Produce Prescription treatment is unique because it involves providing children with prescriptions for fruits and vegetables, which can be redeemed for fresh produce. This approach focuses on improving access to healthy foods and emphasizes the role of diet in health, rather than relying on traditional medical treatments or medications. ^{10 11 12 13 14}

What is the purpose of this trial?

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

Research Team

Ru-Jye Chuang, DrPH, M.S.

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Measuring effectiveness of dietetic interventions in child obesity: a systematic review of randomized trials. [2018]

2. Norway pubmed.ncbi.nlm.nih.gov

Promising results from an implemented treatment model for paediatric obesity. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Implementation of childhood obesity identification and prevention strategies in primary care: A quality improvement project. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a multi-disciplinary family-based programme for treating childhood obesity (the Family Project). [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Building capacity for childhood obesity prevention and treatment in the medical community: call to action. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacological treatment of obesity in paediatric patients. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Pharmacological management of obesity in pediatric patients. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Obesity and Pediatric Drug Development. [2020]

9. Denmark pubmed.ncbi.nlm.nih.gov

An overview of pediatric obesity. [2007]

10. United States 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Pediatric produce prescription initiatives in the U.S.: a scoping review. [2023]

12. England 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. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Effect of a Fruit and Vegetable Prescription Program on Children's Fruit and Vegetable Consumption. [2020]

14. United States pubmed.ncbi.nlm.nih.gov

Produce prescription projects: Challenges, solutions, and emerging best practices - Perspectives from health care providers. [2022]