Food Is Medicine Approaches for Obesity

(EatWell Rx Trial)

AM
Overseen ByAriana M Chao, PhD, CRNP, FNP-BC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
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 aims to determine if providing healthy foods, along with a behavioral weight loss program, helps people with obesity and food insecurity lose more weight. Participants are divided into three groups: one follows only the weight loss program, another receives grocery vouchers with the program, and the last receives home-delivered groceries with the program. The trial will also assess improvements in health-related quality of life and diet quality. It is ideal for adults with obesity (BMI over 30), who face food insecurity, and can walk at least two blocks without stopping. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance weight loss strategies for those facing food insecurity.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you recently started or changed the dosage of a medication that can cause significant weight change, you may not be eligible to participate.

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

Research has shown that "Food Is Medicine" programs, which offer healthy foods and vouchers, are generally safe and well-received. One study found that participants lost weight and improved their eating habits by consuming less salt, sugar, and fat. Another analysis revealed that over 80% of people were satisfied with these programs. Participants also experienced a significant reduction in food insecurity and obesity. These findings suggest that the treatments in this trial are not only safe but also positively impact weight and health.12345

Why are researchers excited about this trial?

Researchers are excited about the "Food Is Medicine" approaches for obesity because these methods aim to integrate dietary changes with behavioral weight loss (BWL) strategies in innovative ways. Unlike standard obesity treatments, which often focus solely on medication or surgery, these approaches incorporate food-based interventions to address the root causes of obesity. The BWL+Voucher arm provides participants with food vouchers, potentially making healthier food more accessible and affordable. The BWL+Home arm takes it a step further by delivering healthy meals directly to participants' homes, simplifying the process of maintaining a nutritious diet. These strategies not only focus on weight loss but also on changing food environments and behaviors, offering a holistic alternative to traditional treatments.

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

Research has shown that "Food Is Medicine" programs, such as home-delivered groceries and grocery vouchers, can aid in weight loss. In this trial, participants will join different treatment arms: BWL-Alone, BWL+Voucher, and BWL+Home. Participants in these programs have experienced a decrease in body mass index (BMI) and have adopted healthier eating habits, such as consuming less salt, sugar, and fat. One study found that vouchers for fruits and vegetables improved health outcomes in preventing obesity. These findings suggest that making healthy food more accessible can support weight loss, especially when combined with strategies to change eating behaviors. Overall, these approaches appear promising in helping people with obesity, particularly those who struggle to afford food, achieve better health.13678

Who Is on the Research Team?

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Ariana Chao, PhD, CRNP, FNP-BC

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Adults over 18 with obesity (BMI >30) and food insecurity can join this trial. They must be able to walk two blocks, provide consent, participate in all activities, and share food receipts. Women of childbearing age need to use contraception.

Inclusion Criteria

My BMI is over 30.
I am 18 years old or older.
I have completed all initial health assessments.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 21 sessions of Behavioral Weight Loss (BWL) over 52 weeks, with additional interventions of either grocery vouchers or home-delivered groceries for the first 24 weeks

52 weeks
21 sessions (1-on-1 with a counselor), 4 in-person assessments

Follow-up

Participants are monitored for changes in weight, dietary quality, and health-related quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Food Is Medicine Approaches

Trial Overview

The study tests if adding home-delivered groceries or grocery vouchers to behavioral weight loss programs helps adults with obesity lose more weight than the program alone.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: BWL+VoucherExperimental Treatment2 Interventions
Group II: BWL+HomeExperimental Treatment2 Interventions
Group III: BWL-AloneActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials
623
Recruited
10,400,000+

Citations

Trial of Food Is Medicine Approaches for Obesity Treatment ...

Is the addition of HOME to BWL more effective at supporting adults with food insecurity and obesity to lose weight when compared to BWL and ...

Food is Medicine: The Effectiveness of Delaware's Feeding ...

Participants demonstrated significant reductions in BMI and improved dietary behaviors, including decreased consumption of sodium, sugar, and fats. While ...

A Systematic Review of “Food Is Medicine” Randomized ...

This review identified a total of 14 randomized controlled trials of Food Is Medicine interventions in the United States with noncommunicable disease outcomes.

Evaluation of a Fruit and Vegetable Voucher Program ...

This study describes how fruit and vegetable vouchers integrated into primary care-based prenatal and pediatric obesity prevention are associated with maternal ...

Tufts University

Poor nutrition and food insecurity are major drivers of poor health outcomes and excess healthcare spending in the United States.

Food Is Medicine Approaches for Obesity (EatWell Rx Trial)

The study tests if adding home-delivered groceries or grocery vouchers to behavioral weight loss programs helps adults with obesity lose more ...

“Food Is Medicine” Strategies for Nutrition Security and ...

Pre/post analyses at 6 months demonstrated >80% program satisfaction, an 18% absolute decrease in food insecurity, 2-point drop in BMI, 9% decrease in obesity, ...

Food Is Medicine: A Presidential Advisory From the ...

Heart-healthy dietary patterns have also been linked to reduced risk of obesity, hypertension, dyslipidemia, and the metabolic syndrome. They ...