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

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• BMI\>30 kg/m2

• Screening positive for food insecurity using the well-validated, 10-item US Adult Food Security Survey Module.

• Age 18 years and older

• Completion of baseline assessments

• Ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest)

• Willing and able to provide pictures of food receipts to study team (or mail receipts to study team)

• Willing and able to provide written informed consent and participate in all study activities

• Female participants of child-bearing potential must agree in writing to use an approved method of contraception during the study

Locations
United States
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Contact Information
Primary
Ariana M Chao, PhD, CRNP, FNP-BC
ariana.chao@jhu.edu
667-208-7078
Time Frame
Start Date: 2026-03-13
Estimated Completion Date: 2030-07-30
Participants
Target number of participants: 300
Treatments
Active_comparator: BWL-Alone
Participants receive BWL-Alone
Experimental: BWL+Voucher
Participants receive BWL+Voucher
Experimental: BWL+Home
Participants receive BWL+Home
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Nursing Research (NINR)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov