FoodRx for Obesity Treatment

University of Pennsylvania

Status: Completed

Conditions: Obesity; Food Insecurity

Treatments: Behavioral: BWL+HOME; Behavioral: BWL+VOUCHER; Behavioral: Behavioral weight loss counseling (BWL)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05635019

852467

R56NR020466-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Age >18 years
4. BMI >30 kg/m2 at screening visit
5. Screening positive for food insecurity using a score of >3 on the 10-item US Adult Food Security Survey Module109
6. Completion of baseline assessments
7. Ability to engage in physical activity (i.e., can walk at least 2 blocks)
8. Willing and able to provide pictures of food receipts to study team (or mail actual receipts)
9. Ability to reliably receive packages at a consistent location in a timely manner
10. Telephone or internet service to communicate with study staff
11. For females of reproductive potential: agreement to use of highly effective contraception for during study participation

Exclusion criteria

1. 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
2. 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
3. Breastfeeding, pregnant or planning pregnancy in the next 6 months
4. Planned move from the Philadelphia area in the next 6 months
5. Weight loss of >5 kg in the previous 90 days
6. Recently began a course of or changed the dosage of medication that can cause significant weight change (±5 kg)
7. Previous or planned obesity treatment with surgery (excluding lap band if removed for >1 year) or a weight-loss device
8. Use of prescription or over the counter medications for chronic weight management in the past 3 months
9. Household member already participating in study due to potential contamination effects
10. Lack of stable residence and ability to store and prepare food

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Behavioral weight loss counseling (BWL) alone

Active Comparator group

Description:

BWL counseling alone

Treatment:

Behavioral: Behavioral weight loss counseling (BWL)

BWL+VOUCHER

Experimental group

Description:

BWL counseling and gift cards to grocery stores

Treatment:

Behavioral: Behavioral weight loss counseling (BWL)

Behavioral: BWL+VOUCHER

BWL+HOME

Experimental group

Description:

BWL counseling and home-delivered boxes of groceries

Treatment:

Behavioral: Behavioral weight loss counseling (BWL)

Behavioral: BWL+HOME