FoodRx for Obesity Treatment

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT05635019
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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+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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 1, 2022
Status verified
Dec 2025
Primary completion
Jul 1, 2024
Completion
Jul 1, 2024

Study Design

Enrollment
105 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Behavioral weight loss counseling (BWL) alone
    BWL counseling alone
  • Experimental: BWL+VOUCHER
    BWL counseling and gift cards to grocery stores
  • Experimental: BWL+HOME
    BWL counseling and home-delivered boxes of groceries

Primary Outcome Measure

Percent Change in Total Body Weight at 24 Weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone) [ Time Frame: Change from baseline to 24 weeks ]

Locations (1)

FacilityCityStateZIP
University of PennsylvaniaPhiladelphiaPennsylvania19104

Find similar trials in Philadelphia, PA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Pennsylvania· Philadelphia, PA

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