Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07396805

Trial of Food Is Medicine Approaches for Obesity Treatment in Adults With Food Insecurity

Led by Johns Hopkins University · Updated on 2026-03-16

300

Participants Needed

1

Research Sites

228 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

N

National Institute of Nursing Research (NINR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if increased access to healthy foods, combined with behavioral weight loss (BWL) interventions, results in greater weight loss for adults with obesity and food insecurity. It will also learn about changes in health-quality of life and dietary quality. The main questions it aims to answer are: * Does BWL, combined with either home-delivered, medically-tailored (HOME) groceries or grocery vouchers (VOUCHER), result in greater weight loss than BWL alone? * 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 VOUCHER?

CONDITIONS

Official Title

Trial of Food Is Medicine Approaches for Obesity Treatment in Adults With Food Insecurity

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years and older
  • Body mass index (BMI) greater than 30 kg/m2
  • Screen positive for food insecurity using the 10-item US Adult Food Security Survey Module
  • Completion of baseline assessments
  • Ability to walk at least 2 blocks without resting
  • Willing and able to provide food receipt pictures or mail receipts to the study team
  • Willing and able to give written informed consent and participate in all study activities
  • Female participants of child-bearing potential must agree to use approved contraception during the study
Not Eligible

You will not qualify if you...

  • Significant psychiatric conditions such as active substance abuse or schizophrenia that may affect safety or adherence
  • Pregnant or planning to become pregnant within the next year
  • Planning to move from the Baltimore area within the next year
  • Recently started or changed dosage of medication causing significant weight change (±5 kg)
  • Previous or planned obesity treatment involving surgery or weight-loss devices
  • Weight loss greater than 5 kg in the last 90 days
  • Household member already participating in the study
  • Lack of stable housing and ability to store and prepare food
  • No telephone access
  • Severe food allergies
  • Following a specialized diet such as gluten-free

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Johns Hopkins University

Baltimore, Maryland, United States, 21205

Actively Recruiting

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Research Team

A

Ariana M Chao, PhD, CRNP, FNP-BC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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