Clinical trial NCT05362747: ProduceRx: Improving Weight and Cardiovascular Risk in Adults With Food Insecurity and Obesity
Official title: ProduceRx: Improving Weight and Cardiovascular Risk in Adults With Food Insecurity and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: food insecurity
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 be randomized to ProduceRx (12 weekly sessions of in-person, behavioral weight loss counseling (BWL) + produce prescriptions) or a waitlist control (WLC).

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 participants with food insecurity and obesity. Adults (N=40) will be randomized to a 12-week program that provides weekly, 30-minute BWL sessions + produce vouchers (n=20) or WLC (n=20). Outcomes will be assessed at baseline and at 12 weeks and include questionnaires, and measurements of weight, height, and cardiometabolic risk factors (blood pressure, waist circumference, and pulse). Participants will also be asked to complete two 24-hour dietary recalls.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old
2. BMI ≥ 30 kg/m2
3. Food insecurity as assessed by the two-item "hunger vital sign"
4. Subjects must:

   1. have reliable telephone or Internet service to communicate with study staff
   2. plan to remain in the Philadelphia area for the next 6 months or more
5. Understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent.

Exclusion Criteria:

1. Pregnant, nursing, or plans to become pregnant in the next 6 months
2. 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)
3. Clinically significant hepatic or renal disease
4. History of (or plans for) bariatric surgery
5. Current psychiatric disorder that significantly interferes with daily living
6. Self-reported alcohol or substance abuse within the past 12 months
7. 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)
8. Loss of ≥ 10 lb of body weight within the past 3 months
9. Participation in a structured weight loss program in the prior 6 months
10. Inability to walk 2 blocks comfortably or engage in some other form of aerobic activity (e.g., swimming)
11. Participant from same household
12. Inability to attend treatment and/or assessment visits
13. Lack of capacity to provide informed consent
14. 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

Primary outcomes:
measure: Dietary quality
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Percent initial weight loss
timeFrame: Baseline, 12 weeks
measure: Systolic blood pressure
timeFrame: Baseline, 12 weeks
measure: Diastolic blood pressure
timeFrame: Baseline, 12 weeks
measure: Waist circumference
timeFrame: Baseline, 12 weeks
measure: Pulse
timeFrame: Baseline, 12 weeks
measure: Health-related quality of life
timeFrame: Baseline, 12 weeks
measure: Weight-related quality of life
timeFrame: Baseline, 12 weeks
measure: Food security
timeFrame: Baseline, 12 weeks
measure: Depressive symptoms
timeFrame: Baseline, 12 weeks
measure: Food addiction
timeFrame: Baseline, 12 weeks
measure: Eating behaviors
timeFrame: Baseline, 12 weeks
measure: Self-regulation of eating
timeFrame: Baseline, 12 weeks
measure: Self-regulation of exercise
timeFrame: Baseline, 12 weeks
measure: Self-efficacy
timeFrame: Baseline, 12 weeks
measure: Physical activity
timeFrame: Baseline, 12 weeks
measure: Perceived Stress Scale
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ariana M Chao, PhD, CRNP
role: PRINCIPAL_INVESTIGATOR
References: