Back to resultsProduceRx: Improving Weight and Cardiovascular Risk in Adults With Food Insecurity and Obesity
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral weight loss and produce vouchers
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring food insecurity
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ProduceRx
Waitlist Control
Arm Description
Participants in the ProduceRx intervention group will be provided with BWL and produce vouchers for fresh fruits and vegetables.
Participants in the WLC group with be asked to stay weight stable, not to make changes in their eating and physical activity behaviors, and not to seek treatment for weight or eating during the waiting period.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percent initial weight loss
Change from baseline to 12 weeks in percent initial weight loss
Systolic blood pressure
Change from baseline to 12 weeks in systolic blood pressure
Diastolic blood pressure
Change from baseline to 12 weeks in diastolic blood pressure
Waist circumference
Change from baseline to 12 weeks in waist circumference
Pulse
Change from baseline to 12 weeks in pulse rate
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.
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.
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.
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.
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.
Eating behaviors
Change from baseline to 12 weeks in Eating Behaviors. Higher scores indicate greater agreement.
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.
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.
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.
Physical activity
Change from baseline to 12 weeks in scores on the International Physical Activity Questionnaire. Higher scores indicate more physical activity.
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.
Full Information
NCT ID
NCT05362747
First Posted
April 26, 2022
Last Updated
July 11, 2023
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT05362747
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
June 2, 2023 (Actual)
Study Completion Date
June 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
food insecurity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ProduceRx
Arm Type
Experimental
Arm Description
Participants in the ProduceRx intervention group will be provided with BWL and produce vouchers for fresh fruits and vegetables.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Participants in the WLC group with be asked to stay weight stable, not to make changes in their eating and physical activity behaviors, and not to seek treatment for weight or eating during the waiting period.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral weight loss and produce vouchers
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dietary quality
Description
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.
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Percent initial weight loss
Description
Change from baseline to 12 weeks in percent initial weight loss
Time Frame
Baseline, 12 weeks
Title
Systolic blood pressure
Description
Change from baseline to 12 weeks in systolic blood pressure
Time Frame
Baseline, 12 weeks
Title
Diastolic blood pressure
Description
Change from baseline to 12 weeks in diastolic blood pressure
Time Frame
Baseline, 12 weeks
Title
Waist circumference
Description
Change from baseline to 12 weeks in waist circumference
Time Frame
Baseline, 12 weeks
Title
Pulse
Description
Change from baseline to 12 weeks in pulse rate
Time Frame
Baseline, 12 weeks
Title
Health-related quality of life
Description
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.
Time Frame
Baseline, 12 weeks
Title
Weight-related quality of life
Description
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.
Time Frame
Baseline, 12 weeks
Title
Food security
Description
Change from baseline to 12 weeks in the USDA Food Security Survey. Scores range from 0-10 with higher scores indicating lower food security.
Time Frame
Baseline, 12 weeks
Title
Depressive symptoms
Description
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.
Time Frame
Baseline, 12 weeks
Title
Food addiction
Description
Change from baseline to 12 weeks in Yale Food Addiction Scores. Symptom scores range from 0 to 11 with higher scores indicating more symptoms.
Time Frame
Baseline, 12 weeks
Title
Eating behaviors
Description
Change from baseline to 12 weeks in Eating Behaviors. Higher scores indicate greater agreement.
Time Frame
Baseline, 12 weeks
Title
Self-regulation of eating
Description
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.
Time Frame
Baseline, 12 weeks
Title
Self-regulation of exercise
Description
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.
Time Frame
Baseline, 12 weeks
Title
Self-efficacy
Description
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.
Time Frame
Baseline, 12 weeks
Title
Physical activity
Description
Change from baseline to 12 weeks in scores on the International Physical Activity Questionnaire. Higher scores indicate more physical activity.
Time Frame
Baseline, 12 weeks
Title
Perceived Stress Scale
Description
Change from baseline to 12 weeks in scores on the Perceived Stress Scale. Scores range from 0-56 with higher scores indicating more stress.
Time Frame
Baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariana M Chao, PhD, CRNP
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ProduceRx: Improving Weight and Cardiovascular Risk in Adults With Food Insecurity and Obesity
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