NCT05635019Completed
FoodRx for Obesity Treatment
Food Supplementation Interventions to Improve Weight Loss for Adults With Food Insecurity and Obesity
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
This study is a 3-group, parallel design, randomized controlled trial (RCT) in 105 adults with obesity and food insecurity that will compare BWL-Alone (including standard-of-care referral and connection with community food resources; n=35) to BWL plus food supplementation with either food vouchers (BWL+VOUCHER; n=35) or home-delivered, medically tailored groceries consistent with BWL recommendations (BWL+HOME; n=35). All groups will have BWL treatment provided for 24 weeks per clinical guidelines. Food vouchers and HOME will be provided for 24 weeks of treatment. Assessments will be conducted at baseline, and weeks 12 and 24.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 105 (actual)
- First submitted
- 22 Nov 2022
- Start date
- 1 Dec 2022
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- University of Pennsylvania
- Diseases
- Obesity
- NCT number
- NCT05635019
What you commit to
- Study type: Interventional
- Participants enrolled: 105
- From 1 Dec 2022 to the primary completion date, 1 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Weight loss of \>5 kg in the previous 90 days
- 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 (excluding lap band if removed for \>1 year) or a weight-loss device
- Use of prescription or over the counter medications for chronic weight management in the past 3 months
Other illness
- Serious medical conditions (e.g., type 1 or type 2 diabetes, renal failure) 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
- 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
Other
- Breastfeeding, pregnant or planning pregnancy in the next 6 months
- Planned move from the Philadelphia area in the next 6 months
- Household member already participating in study due to potential contamination effects
- Lack of stable residence and ability to store and prepare food
Who the study is looking for
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age \>18 years
- BMI \>30 kg/m2 at screening visit
- Screening positive for food insecurity using a score of \>3 on the 10-item US Adult Food Security Survey Module109
- Completion of baseline assessments
- Ability to engage in physical activity (i.e., can walk at least 2 blocks)
- Willing and able to provide pictures of food receipts to study team (or mail actual receipts)
- Ability to reliably receive packages at a consistent location in a timely manner
- Telephone or internet service to communicate with study staff
- For females of reproductive potential: agreement to use of highly effective contraception for during study participation
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.