FoodRx for Obesity Treatment

NCT05635019 | Completed Results

• 2 other identifiers: 852467R56NR020466-01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Food Insecurity

Keywords

obesity; food insecurity; weight loss

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline to 24 weeks

Secondary Outcomes (9)

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

  Change from baseline to 24 weeks

• General Health-related Quality of Life (BWL+VOUCHER and BWL+HOME vs BWL-Alone)

  Change from baseline to 24 weeks

• Weight-related Quality of Life (BWL+VOUCHER and BWL+HOME vs BWL-Alone)

  Change from baseline to 24 weeks

• Dietary Quality as Assessed by Skin Carotenoid Levels (BWL+VOUCHER and BWL+HOME vs BWL-Alone)

  Change from baseline to 24 weeks

• Dietary Quality as Assessed by the Healthy Eating Index (BWL+VOUCHER and BWL+HOME vs BWL-Alone)

  Change from baseline to 24 weeks

Study Arms (3)

Behavioral weight loss counseling (BWL) alone

ACTIVE COMPARATOR

BWL counseling alone

Behavioral: Behavioral weight loss counseling (BWL)

BWL+VOUCHER

EXPERIMENTAL

BWL counseling and gift cards to grocery stores

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

BWL+HOME

EXPERIMENTAL

BWL counseling and home-delivered boxes of groceries

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

Interventions

BWL+VOUCHER BEHAVIORAL

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+VOUCHER

BWL+HOME BEHAVIORAL

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.

BWL+HOME

Behavioral weight loss counseling (BWL) BEHAVIORAL

The behavioral weight loss program consists of 14 individual lifestyle counseling sessions provided over 24 weeks. Each session will be approximately 15-20 minutes. Visits will be scheduled weekly for the first 4 weeks (weeks 1, 2, 3, and 4) and every-other week from weeks 6-24 (weeks 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24). The sessions will provide behavioral, dietary, and physical counseling.

BWL+HOME; BWL+VOUCHER; Behavioral weight loss counseling (BWL) alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Ariana Chao
• Organization: University of Pennsylvania and Johns Hopkins University

ariana.chao@jhu.edu

443-287-6223

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: December 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-12

Locations

US (1)