N/A
N=105
FoodRx for Obesity Treatment
Obesity · Food Insecurity
Bottom Line
View on ClinicalTrials.gov: NCT05635019 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Percent Change in Total Body Weight at 24 Weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone) — -2.7; -3.0 Percent initial weight loss
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BWL+VOUCHER (Behavioral); BWL+HOME (Behavioral); Behavioral weight loss counseling (BWL) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Total Body Weight at 24 Weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone) |
-2.7; -3.0 | — |
| SECONDARY Percent Change in Total Body Weight at 24 Weeks (BWL+HOME vs BWL+VOUCHER) |
-3.5; -2.7 | — |
| SECONDARY General Health-related Quality of Life (BWL+VOUCHER and BWL+HOME vs BWL-Alone) |
-0.5; -0.64 | — |
| SECONDARY Weight-related Quality of Life (BWL+VOUCHER and BWL+HOME vs BWL-Alone) |
7.8; 8.8 | — |
| SECONDARY Dietary Quality as Assessed by Skin Carotenoid Levels (BWL+VOUCHER and BWL+HOME vs BWL-Alone) |
15.6; 7.1 | — |
| SECONDARY Dietary Quality as Assessed by the Healthy Eating Index (BWL+VOUCHER and BWL+HOME vs BWL-Alone) |
0.4; 10.8; .8 | — |
| SECONDARY General Health-related Quality of Life (BWL+VOUCHER vs BWL+HOME) |
0.4; -1.6 | — |
| SECONDARY Weight-related Quality of Life (BWL+VOUCHER vs BWL+HOME) |
0.4; -1.6 | — |
| SECONDARY Dietary Quality as Assessed by Skin Carotenoid Levels (BWL+VOUCHER vs BWL+HOME) |
16.2; -1.6 | — |
| SECONDARY Dietary Quality as Assessed by the Healthy Eating Index (BWL+VOUCHER vs BWL+HOME) |
10.8; .8 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- Breastfeeding, pregnant or planning pregnancy in the next 6 months
- Planned move from the Philadelphia area in the next 6 months
- 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
- Household member already participating in study due to potential contamination effects
- Lack of stable residence and ability to store and prepare food
Data sourced from ClinicalTrials.gov (NCT05635019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.