Produce Prescription Programs for Obesity

Overseen By Hailey Miller Assistant Professor, RN, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Weight loss drugs

Disqualifiers: Cardiovascular disease, Active cancer, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

46 Participants Needed

Trial Summary

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.

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

Produce Prescription Programs are unique because they focus on providing patients with fresh fruits and vegetables as a form of treatment, which is different from traditional methods like medication, surgery, or meal replacements. This approach emphasizes improving diet quality and increasing access to healthy foods, which can lead to weight loss and better overall health. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this study is to understand the best practices for implementing produce prescriptions among adults with overweight or obesity experiencing nutrition insecurity. Enrolled participants will receive an 8-week intervention aimed at increasing nutrition knowledge, self-efficacy for healthy eating, and barriers to healthy food access. Participants will be randomly assigned to one of two produce prescription implementation strategies: Program 1: Participants will receive weekly produce vouchers that are redeemable at a local vendor. Program 2. Participants will receive fresh produce delivered directly to the participant's home. These boxes will be tailored based on household size, cooking and preparation preferences, and produce the participant prefers to receive. Researchers will compare engagement in and adherence to the intervention and the patterns of difference in 8-week changes in fruit and vegetable consumption and weight.

Research Team

Hailey Miller Assistant Professor, RN, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

Exclusion Criteria

Weight exceeding 440 lbs.

Exclusion at principal investigator's discretion

I have not had a heart problem in the last 6 months.

Timeline

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)

Treatment Details

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.

Participant Groups

Group I: Produce Voucher Experimental Treatment 1 Intervention

Behavioral Text Message Program + Produce Voucher

Group II: Produce Boxes Experimental Treatment 1 Intervention

Behavioral Text Message Program + Produce Box Delivery

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Successful treatment of obesity]. Wechsler, JG., Leopold, K., Bischoff, G.[2019]

Obesity significantly increases the risk of various health issues, including hypertension, diabetes, and heart disease, yet many physicians feel unprepared to address this widespread problem among U.S. adults.

Effective management strategies for obesity include recommending self-management techniques, advising on diets and commercial weight-loss programs, prescribing medications like sibutramine and orlistat alongside lifestyle changes, and considering bariatric surgery for individuals with severe obesity or related health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Office-based strategies for the management of obesity. Rao, G.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of medically supervised and unsupervised approaches to weight loss and control. Blackburn, GL.[2019]

Meal replacement products (MRPs) are effective for weight loss in obesity management, but are prescribed to only about 7% of patients by healthcare professionals (HCPs), despite over 70% having prescribed them at some point.

Safety concerns, particularly regarding long-term weight loss durability and the risk of weight cycling, hinder MRP prescriptions; however, HCPs with formal training in MRPs are 66% more likely to prescribe them, indicating that education could improve their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes and Approaches to Use of Meal Replacement Products among Healthcare Professionals in Management of Excess Weight. Maston, G., Franklin, J., Gibson, AA., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in and patterns of obesity reduction medication use in an insured cohort. Bolen, SD., Clark, JM., Richards, TM., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Successful treatment of obesity]. [2019]

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

Office-based strategies for the management of obesity. [2018]

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

Comparison of medically supervised and unsupervised approaches to weight loss and control. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Attitudes and Approaches to Use of Meal Replacement Products among Healthcare Professionals in Management of Excess Weight. [2023]

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

Trends in and patterns of obesity reduction medication use in an insured cohort. [2021]