ProduceRx: Improving Weight and Cardiovascular Risk in Adults With Food Insecurity and Obesity

Obesity Clinical Trial

Official title:

ProduceRx: Improving Weight and Cardiovascular Risk in Adults With Food Insecurity and Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05362747
• Other study ID #: 851009
• Status: Completed
• Phase: N/A
• Start date: April 26, 2022
• Est. completion date: June 2, 2023

Study information

• Verified date: July 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2, 2023
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Behavioral weight loss and produce vouchers
Participants will receive weekly 30-minute, individual, in-person lifestyle counseling delivered by trained interventionists (e.g., registered dietitians) that consists of behavioral, dietary, and physical activity counseling. ProduceRx vouchers will be in the form of Food Bucks and will be provided at each session.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary quality	Change from baseline to 12 weeks in dietary quality from 24-hour dietary recalls summarized into Healthy Eating Index (HEI) Scores and caloric intake. Scores range from 0 to 100 with higher scores indicating better diet quality.	Baseline, 12 weeks
Secondary	Percent initial weight loss	Change from baseline to 12 weeks in percent initial weight loss	Baseline, 12 weeks
Secondary	Systolic blood pressure	Change from baseline to 12 weeks in systolic blood pressure	Baseline, 12 weeks
Secondary	Diastolic blood pressure	Change from baseline to 12 weeks in diastolic blood pressure	Baseline, 12 weeks
Secondary	Waist circumference	Change from baseline to 12 weeks in waist circumference	Baseline, 12 weeks
Secondary	Pulse	Change from baseline to 12 weeks in pulse rate	Baseline, 12 weeks
Secondary	Health-related quality of life	Change from baseline to 12 weeks in general health-related quality of life (Short-Form-36). Scores range from 0 to 100 with higher scores indicating better quality of life.	Baseline, 12 weeks
Secondary	Weight-related quality of life	Change from baseline to 12 weeks in weight-related QOL (Impact of Weight on Quality of Life-Lite). Scores range from 0 to 100 with higher scores indicating better quality of life.	Baseline, 12 weeks
Secondary	Food security	Change from baseline to 12 weeks in the USDA Food Security Survey. Scores range from 0-10 with higher scores indicating lower food security.	Baseline, 12 weeks
Secondary	Depressive symptoms	Change from baseline to 12 weeks in Patient Health Questionnaire-8 Scores. Scores range from 0 to 24 with higher scores indicating more depressive symptoms.	Baseline, 12 weeks
Secondary	Food addiction	Change from baseline to 12 weeks in Yale Food Addiction Scores. Symptom scores range from 0 to 11 with higher scores indicating more symptoms.	Baseline, 12 weeks
Secondary	Eating behaviors	Change from baseline to 12 weeks in Eating Behaviors. Higher scores indicate greater agreement.	Baseline, 12 weeks
Secondary	Self-regulation of eating	Change from baseline to 12 weeks in self-regulation of eating as measured by the Regulation of Eating Behavior Scale. Scores range from 24 to 168 with higher scores indicating more self-regulation.	Baseline, 12 weeks
Secondary	Self-regulation of exercise	Change from baseline to 12 weeks in Behavioral Regulation in Exercise Questionnaire. Scores range from 0 to 76 with higher scores indicating more self-regulation.	Baseline, 12 weeks
Secondary	Self-efficacy	Change from baseline to 12 weeks in scores on the Weight Efficacy Lifestyle Questionnaire. Total scores range from 0 to 180. Higher scores represent greater eating self-efficacy.	Baseline, 12 weeks
Secondary	Physical activity	Change from baseline to 12 weeks in scores on the International Physical Activity Questionnaire. Higher scores indicate more physical activity.	Baseline, 12 weeks
Secondary	Perceived Stress Scale	Change from baseline to 12 weeks in scores on the Perceived Stress Scale. Scores range from 0-56 with higher scores indicating more stress.	Baseline, 12 weeks