Status:
COMPLETED
ProduceRx: Improving Weight and Cardiovascular Risk in Adults With Food Insecurity and Obesity
Lead Sponsor:
University of Pennsylvania
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a pilot randomized controlled trial to assess the effects of providing produce vouchers during behavioral weight loss treatment in 40 adults with obesity and food insecurity. Participants will...
Detailed Description
The proposed investigation is a single-site, pilot RCT to assess the effect of BWL and produce vouchers (ProduceRx) on diet quality, weight loss and cardiovascular risk factors among adult participant...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- BMI ≥ 30 kg/m2
- Food insecurity as assessed by the two-item "hunger vital sign"
- Subjects must:
- have reliable telephone or Internet service to communicate with study staff
- plan to remain in the Philadelphia area for the next 6 months or more
- Understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent.
Exclusion
- Pregnant, nursing, or plans to become pregnant in the next 6 months
- Serious medical risk such as uncontrolled diabetes, cancer, congestive heart failure, or recent cardiac event (e.g., myocardial infarction or stroke within the past 6 months)
- Clinically significant hepatic or renal disease
- History of (or plans for) bariatric surgery
- Current psychiatric disorder that significantly interferes with daily living
- Self-reported alcohol or substance abuse within the past 12 months
- Use in past 3 months of medications known to induce significant weight loss (i.e., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)
- Loss of ≥ 10 lb of body weight within the past 3 months
- Participation in a structured weight loss program in the prior 6 months
- Inability to walk 2 blocks comfortably or engage in some other form of aerobic activity (e.g., swimming)
- Participant from same household
- Inability to attend treatment and/or assessment visits
- Lack of capacity to provide informed consent
- Any serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study
Key Trial Info
Start Date :
April 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05362747
Start Date
April 26 2022
End Date
June 2 2023
Last Update
July 12 2023
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104