Produce Prescription Programs for Obesity

PO
HM
Overseen ByHailey Miller Assistant Professor, RN, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best ways to provide fresh produce to adults dealing with obesity and nutrition insecurity. Participants will either receive weekly vouchers to buy produce or have fresh produce delivered to their homes. Researchers aim to assess how these methods affect fruit and vegetable intake and weight over eight weeks. Adults with a BMI of 25 or higher who struggle to access nutritious food and own a smartphone are ideal candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative solutions for improving access to nutritious food.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking weight loss drugs.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that programs providing vouchers for fruits and vegetables are safe for individuals. These vouchers make healthy foods more affordable and accessible, enabling people to purchase more fruits and vegetables, which benefits their health.

Regarding produce boxes, studies have found that home delivery of fresh produce can improve dietary habits and might even lower body mass index (BMI). This indicates that receiving fresh produce at home is safe and can enhance one's diet.

Both methods aim to promote healthier eating by increasing the consumption of fruits and vegetables. No reports of serious side effects or safety concerns have emerged from these programs. They focus on encouraging better eating habits, which is generally safe and beneficial for most people.12345

Why are researchers excited about this trial?

Researchers are excited about Produce Prescription Programs for obesity because they focus on providing fresh fruits and vegetables directly to individuals, unlike traditional treatments that usually involve medication or surgery. These programs aim to change dietary behaviors with a novel approach: one group receives vouchers to purchase produce, while another benefits from direct produce box deliveries. This strategy not only enhances access to nutritious foods but also incorporates a supportive behavioral text message program, which could foster lasting healthy eating habits and potentially lead to more sustainable weight management.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will compare two approaches: providing vouchers for fruits and vegetables and delivering produce boxes to participants' homes. Studies have shown that voucher programs can lead to healthier eating habits and improved health. Research indicates that these vouchers help people consume more fruits and vegetables and feel more confident in choosing healthy foods. These programs have also been linked to better management of conditions like diabetes and obesity. Participants receiving produce boxes delivered to their homes have experienced similar benefits, such as increased fruit and vegetable intake and a healthier diet. Overall, both approaches aim to make healthy food more accessible and affordable, potentially leading to significant health improvements.678910

Who Is on the Research Team?

HM

Hailey Miller Assistant Professor, RN, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults who are overweight or obese and have trouble getting enough nutritious food. They should be interested in improving their eating habits but haven't started any other nutrition programs recently.

Inclusion Criteria

My BMI is 25 or higher.
Is willing to pick up produce at the Northeast Market
Screens positive for nutrition insecurity
See 4 more

Exclusion Criteria

Weight exceeding 440 lbs.
Exclusion at principal investigator's discretion
I have not had a heart problem in the last 6 months.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive an 8-week intervention aimed at increasing nutrition knowledge, self-efficacy for healthy eating, and reducing barriers to healthy food access. Participants are randomly assigned to receive either weekly produce vouchers or fresh produce delivered to their home.

8 weeks
Weekly interactions (in-person or virtual)

Follow-up

Participants are monitored for changes in fruit and vegetable consumption, weight, and nutrition insecurity.

4 weeks
2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Produce Prescription Programs
Trial Overview The study tests two ways to help people eat better: one group gets text messages and vouchers for fresh produce, while the other gets texts plus a box of fresh produce delivered home, tailored to their needs.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Produce VoucherExperimental Treatment1 Intervention
Group II: Produce BoxesExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Maryland Cigarette Restitution Fund

Collaborator

Trials
10
Recruited
900+

Maryland Department of Health and Mental Hygiene

Collaborator

Trials
9
Recruited
5,000+

Published Research Related to This Trial

Obesity reduction medication use among insured individuals in the U.S. significantly decreased from 1% in 2002 to 0.7% in 2005, particularly for newer medications like orlistat and sibutramine.
Only a small percentage (11-18%) of users continued these medications for longer than 3 months, highlighting potential issues with long-term adherence and the need for prescribers to consider contraindications and patient screening for related health issues.
Trends in and patterns of obesity reduction medication use in an insured cohort.Bolen, SD., Clark, JM., Richards, TM., et al.[2021]
Interdisciplinary long-term programs involving physicians, psychologists, physiotherapists, and dieticians are essential for effectively treating obesity and improving patient outcomes.
Combination treatments, such as formula diets followed by reduction diets and behavioral therapy with physiotherapy, have shown to be successful in reducing obesity and its associated health risks.
[Successful treatment of obesity].Wechsler, JG., Leopold, K., Bischoff, G.[2019]
Physician involvement in weight loss programs can significantly improve outcomes, as even minimal contact may enhance success rates compared to unsupervised efforts.
Medical supervision is crucial for patients on very-low-calorie diets, those who are severely obese (BMI > 35), and individuals with other health issues, to ensure safety and monitor health during weight loss.
Comparison of medically supervised and unsupervised approaches to weight loss and control.Blackburn, GL.[2019]

Citations

Abstract 4369071: Produce Prescription Delivery and ...Median (Q1, Q3) dietary quality at baseline was 58(54, 60), nutrition security was 2.0(1.7, 2.5), and self-efficacy was 33(29.5, 37.5). Median ...
Community-based fruit and vegetable prescription programsProviding financial incentives to offset the cost of fresh fruits and vegetables can increase consumption, improve health outcomes, and improve food security ...
Health and Economic Impact and Cost-effectiveness of ...Produce prescription (PRx) programs have been shown to result in improved dietary quality, diabetes control, and cardiometabolic outcomes.
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.
Examining the context, logistics, and outcomes of food ...Most food prescription programs studied were associated with farmers markets, lasted less than 6 months, and utilized produce consumption and biometric data as ...
Study of Produce Prescription Programs in Adults With ...The goal of this study is to understand the best practices for implementing produce prescriptions among adults with overweight or obesity experiencing nutrition ...
An Urban Farm–Anchored Produce Prescription Program's ...These findings were extended by a recent study pooling data from nine produce prescription programs that found that body mass index decreased by ...
Qualitative Analysis of a Home-Delivered Produce ...Produce prescription interventions (PRx) are a viable intervention to address FI and improve diet quality. Few studies have explored home- ...
Health and Economic Impacts of Implementing Produce ...Based on random effects meta‐analysis, the produce prescription programs increased average fruit and vegetable consumption by 0.80 servings/day ...
Current Landscape of Produce Prescription Programs in ...US produce prescription programs include a health visit, nutrition education, and farmer's market vouchers, often at safety-net clinics, with a median of $15 ...
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