Nutrition Education and Vouchers for Childhood Obesity

Recruiting at 1 trial location

Overseen By Hollie A Raynor, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Tennessee, Knoxville

Disqualifiers: Not CHS Knox County, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to help families make healthier eating and activity choices to address childhood obesity. It provides nutrition education and home deliveries of fresh fruits and vegetables through the EBT Fruit and Vegetable Prescription. Families will set goals such as reducing sugary drinks, eating more fruits and vegetables, and increasing physical activity. Families with children aged 4 to 10, who have a high BMI and are patients at the Cherokee Health Systems clinic, might be a good fit. An adult caregiver must also participate and be able to read and speak English.

As an unphased trial, this study offers families a unique opportunity to improve their health and well-being through personalized support and resources.

Do I have to stop taking my current medications for this trial?

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

What prior data suggests that the EBT Fruit and Vegetable Prescription is safe for children?

Studies have shown that programs prescribing fruits and vegetables are generally well-received. These programs aim to increase participants' fruit and vegetable intake, leading to health benefits without major risks. Research indicates that such programs have helped children achieve healthier weights and consume more fruits and vegetables.

No serious side effects have been reported in these programs. The focus remains on providing families with fresh produce, which is safe and beneficial for health. Although this specific program is new, the concept has been successfully implemented before. Participants can feel confident about the safety of joining a program that promotes healthier eating habits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using EBT Fruit and Vegetable Prescriptions for tackling childhood obesity because it promotes healthier eating habits through a unique approach. Unlike typical treatments that might rely on medication or generalized dietary advice, this method directly encourages increased consumption of fruits and vegetables by providing families with vouchers. This approach not only supports better nutrition but also empowers caregivers and children to make healthier lifestyle choices, potentially leading to long-term behavioral changes. By focusing on energy balance and promoting physical activity, this treatment stands out for its holistic strategy in managing obesity.

What evidence suggests that the EBT Fruit and Vegetable Prescription is effective for childhood obesity?

Research has shown that programs providing fruit and vegetable prescriptions can increase fruit and vegetable consumption among children, especially those from low-income families. In this trial, participants will receive the EBT Fruit and Vegetable Prescription as part of the Prevention Plus program. A study on the Navajo FVRx program found that young children, particularly those who are overweight, consumed more fruits and vegetables. These programs can also enhance diet quality and reduce food insecurity, leading to better overall health. Evidence indicates that these initiatives can improve heart health and lower blood sugar levels, which are crucial for preventing and managing obesity-related conditions. These findings suggest that making fruits and vegetables more accessible can significantly aid in addressing childhood obesity. ^{1 3 4 6 7}

Who Is on the Research Team?

Hollie A Raynor, PhD

Principal Investigator

University of Tennessee, Knoxville

Are You a Good Fit for This Trial?

This trial is for children aged 4-10 with obesity, who are patients at the Cherokee Health Systems clinic and have a BMI over the 85th percentile. They must have an adult caregiver willing to participate, and both child and caregiver should be able to read and speak English.

Inclusion Criteria

Patients at the Cherokee Health Systems clinic in Cherokee Mills

My child is between 4 and 10 years old.

My child's BMI is above the 85th percentile.

Exclusion Criteria

Not patients at the CHS Knox County Pediatric Clinic

I am a child without an adult caregiver willing to join the program.

My child is not between 4 and 10 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Baseline Assessment

Completion of questionnaires and measures of anthropometrics

1-2 weeks

1 visit (in-person or virtual)

Intervention

Families participate in a 6-month intervention with monthly sessions alternating between in-person and phone calls, including fruit and vegetable prescription deliveries

6 months

3 in-person visits, 3 phone calls

Follow-up

Participants are monitored for changes in dietary intake, anthropometrics, and other outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EBT Fruit and Vegetable Prescription

Trial Overview The 'Eating Better Together' program focuses on teaching families about healthy eating habits and physical activity. It includes home deliveries of fresh fruits and vegetables from a local retailer over six months.

How Is the Trial Designed?

Group I: Prevention Plus Experimental Treatment 1 Intervention

Child's energy balance behavioral goals will be to consume \< 3 sugar-sweetened beverages (e.g., regular carbonated soft drinks, sports drinks, lemonades, ice teas, flavored milk, juice drinks \< 100% juice, and punches) servings /wk, ≥1 1/2 cups/day of whole vegetables and ≥ 1 cup/day of whole fruit, engage in ≥ 60 minutes/day of moderate- to vigorous-intensity physical activity, and reduce TV viewing to \< 2 hours/day. The caregiver's energy balance behavioral goals will be to consume \< 3 sugar-sweetened beverage servings/wk, ≥ 2 1/2 cups/day of whole vegetables and ≥ 1 1/2 cups/day of whole fruit, engage in ≥ 150 minutes of moderate- to vigorous-intensity physical activity per week and reduce TV viewing to \< 10 hours/wk.

Who Is Running the Clinical Trial?

The University of Tennessee, Knoxville

Lead Sponsor

Trials

93

Recruited

19,500+

Published Research Related to This Trial

The 'Prevention Produce' program, which combined fruit and vegetable prescriptions with a month-long educational curriculum, successfully increased fruit and vegetable consumption among nine families at risk of chronic disease and food insecurity.

Participants reported a greater understanding of the health benefits of produce, and the mentorship aspect of the program was positively received by both families and medical students, highlighting its potential as a model for integrating preventive health strategies in healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. Forbes, JM., Forbes, CR., Lehman, E., et al.[2020]

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]

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]

A systematic review of 10 studies on food provision programs for patients with type 2 diabetes or prediabetes showed that those including nutrition education consistently reduced HbA1c levels, indicating improved diabetes management.

Programs varied widely in their design and implementation, but those that incorporated nutrition education—covering topics like general nutrition and fruit/vegetable consumption—tended to yield better dietary quality and health outcomes compared to those without such education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education. Schier, HE., Chetty, KS., Garrity, K., et al.[2023]

The Fruit and Vegetable Prescription (FVRx) program significantly increased the consumption of dark green vegetables among participants compared to those in the Ad hoc Nutrition Education and Control groups, indicating its effectiveness in promoting healthier eating habits.

Participants in the FVRx program also showed improved food purchasing practices and financial management, suggesting that combining nutrition education with produce prescriptions can enhance food security and resource management for low-income adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. Slagel, N., Newman, T., Sanville, L., et al.[2022]

The Fruit and Vegetable Prescription Program (F&VRx), combined with cooking and nutrition classes, effectively increased fruit and vegetable consumption among children in low-income rural families, with a 94% redemption rate of online produce credits over 5 months.

After the program, 60% of families continued to shop for produce online, indicating lasting positive changes in healthy shopping and cooking behaviors, despite initial barriers to accessing fresh foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of an online produce market combined with a fruit and vegetable prescription program for rural families. Burrington, CM., Hohensee, TE., Tallman, N., et al.[2020]

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]

A study involving 671 low-income adults showed that providing $20 per month in fruit and vegetable vouchers for 6 months led to an overall increase in fruit and vegetable intake by 0.22 cup-equivalents per day, with a significant increase observed in Los Angeles (0.64 cup-equivalents) compared to San Francisco (0.10 cup-equivalents).

The findings suggest that fruit and vegetable vouchers are particularly beneficial for lower-income populations, indicating that flat-rate benefits may be more effective than income-scaled ones in improving nutritional intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Fruit and Vegetable Intake Among Urban Low-Income US Adults Receiving a Produce Voucher in 2 Cities. Basu, S., Akers, M., Berkowitz, SA., et al.[2022]

Citations

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

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.

2. 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.

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.122.009520

Impact of Produce Prescriptions on Diet, Food Security ... Produce prescriptions may improve cardiometabolic health by increasing fruit and vegetable (F&V) consumption and food insecurity.

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

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.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749379724004112

Impact of Fruit and Vegetable Incentive Programs on Food ... Programs providing incentives to participants at risk for or with diet-related health conditions improved blood glucose levels by a median of 0.64 percentage ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2475299122120469

Impact of a Fruit and Vegetable Prescription Program on ... Among children classified as overweight or obese at baseline, 38% achieved a healthy BMI z score at program completion (P < 0.001). Sixty-five percent of ...

7. health.ny.gov health.ny.gov/prevention/nutrition/docs/full_report.pdf

Nutrition Incentive & Produce Prescription Programs: A New ... All seven programs focus on increasing access to healthy and/or NY-grown produce by providing incentive dollars to purchase fruits and vegetables or NY-produced ...