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

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

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

Research indicates that produce prescription programs, like those implemented by Brighter Bites, are being studied for their potential to improve obesity-related health outcomes and dietary behaviors in children. Although specific results are not yet available, these programs are gaining attention for their innovative approach to addressing childhood obesity. ^{1 2 3 4 5}

Is the Produce Prescription Program safe for children?

The available research on produce prescription programs, which provide fruits and vegetables to children, does not report any safety concerns. These programs focus on improving diet and food security, and healthcare providers have noted positive patient experiences. ^{1 6 7 8 9}

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

The Produce Prescription Program is unique because it involves doctors prescribing fruits and vegetables to children, which can be redeemed at local markets, addressing both dietary habits and access to healthy food. This approach focuses on improving diet and food security rather than traditional medical or pharmaceutical interventions. ^{1 5 7 10 11}

What is the purpose of this trial?

The purpose of this study is to clinically evaluate the effectiveness of an at-home delivery produce prescription in improving weight status and obesity-related health outcomes 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).

Research Team

Shreela Sharma, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. 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]

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

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

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

Childhood obesity: Can electronic medical records customized with clinical practice guidelines improve screening and diagnosis? [2018]

4. Norway pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

7. 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]

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

Obesity and Pediatric Drug Development. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacological treatment of obesity in paediatric patients. [2018]

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

Reducing childhood obesity through coordinated care: Development of a park prescription program. [2020]

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

Food Security and Clinical Outcomes of the 2017 Georgia Fruit and Vegetable Prescription Program. [2021]