Food support plus one-on-one behavioral weight-loss program for adults with obesity and food insecurity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with obesity who screen positive for food insecurity are randomized to one of three groups: behavioral weight-loss (BWL) counseling alone, BWL plus grocery store vouchers every two weeks, or BWL plus medically-tailored groceries delivered to the home every two weeks. All participants receive 21 one-on-one BWL sessions spread over 52 weeks and complete four in-person assessments measuring height, weight, blood pressure, pulse, dietary intake, questionnaires, interviews, and non-invasive skin carotenoid levels. Grocery support (vouchers or home deliveries) is provided during the first 24 weeks of the intervention. The trial compares weight change, diet quality, and health-related quality of life across the three groups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Significant psychiatric conditions (e.g., active substance abuse, schizophrenia) that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the program's behavioral recommendations
* Pregnant or planning pregnancy in the next year
* Planned move from the Baltimore area in the next year
* Recently began a course of or changed the dosage of medication that can cause significant weight change (±5 kg)
* Previous or planned obesity treatment with surgery or a weight-loss device
* Weight loss of \>5 kg in the previous 90 days
* Household member already participating in study due to potential contamination effects
* Lack of stable residence and ability to store and prepare food
* Lack of telephone
* Severe food allergies
* Following a specialized dietary regimen (e.g., gluten-free)

Where it's running

• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Ariana Chao, PhD, CRNP, FNP-BC — Johns Hopkins University
• Study coordinator: Ariana M Chao, PhD, CRNP, FNP-BC
• Email: ariana.chao@jhu.edu
• Phone: 667-208-7078

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.