Food support plus one-on-one behavioral weight-loss program for adults with obesity and food insecurity
A Randomized Controlled Trial of Food Is Medicine Approaches for Obesity Treatment in Adults With Food Insecurity
This trial will test whether adding home-delivered groceries or grocery vouchers to a one-on-one behavioral weight-loss program helps adults with obesity who face food insecurity lose more weight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT07396805 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with BMI >30 kg/m2 who screen positive for food insecurity, can walk at least two blocks, complete baseline assessments, provide food receipts, and consent to participate are the intended candidates.
Not a fit: People without food insecurity, with BMI ≤30 kg/m2, who are pregnant or planning pregnancy, have significant unmanaged psychiatric conditions, or plan to move away from the Baltimore area are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding grocery support to behavioral counseling could produce greater weight loss, improved dietary quality, and better quality of life for food-insecure adults with obesity.
How similar studies have performed: Previous programs providing medically tailored meals or grocery vouchers have improved diet quality and some cardiometabolic outcomes, but rigorous trials showing added weight loss when those supports are combined with behavioral weight-loss counseling in food-insecure adults remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.