FoodRx for Obesity Treatment

University of Pennsylvania105 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Obesity Food Insecurity

Interventions

BWL+VOUCHERBEHAVIORAL

This group will receive the BWL program as well as food vouchers, in the form of grocery store gift cards. Participants will be allowed to select to receive gift cards to a grocery store or supermarket from a pre-determined list of stores. Gift cards worth $40 will be emailed or mailed to every 2 weeks after the BWL session.

BWL+HOMEBEHAVIORAL

This group will receive the BWL program as well as home-delivered boxes of groceries of low-energy density foods conducive to weight management guidelines. Groceries will include shelf-stable and perishable products like lean meats, fresh vegetables, and fruits. Every 2 weeks, participants assigned to this group will be allowed to select a choice of one of 4 boxes with slightly varied contents. Each box will have approximately $40 worth of groceries.

Behavioral weight loss counseling (BWL)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Percent Change in Total Body Weight at 24 Weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone)

Comparison of BWL+VOUCHER and BWL+HOME vs BWL-Alone in weight change (percent of initial weight) at 24 weeks. Positive numbers represent increases and negative numbers represent decreases.