Obesity
Conditions
Keywords
food insecurity
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.
Interventions
BEHAVIORALBehavioral 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.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dietary quality | Baseline, 12 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | Baseline, 12 weeks | Change from baseline to 12 weeks in systolic blood pressure |
| Diastolic blood pressure | Baseline, 12 weeks | Change from baseline to 12 weeks in diastolic blood pressure |
| Waist circumference | Baseline, 12 weeks | Change from baseline to 12 weeks in waist circumference |
| Pulse | Baseline, 12 weeks | Change from baseline to 12 weeks in pulse rate |
| Health-related quality of life | Baseline, 12 weeks | 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 | Baseline, 12 weeks | 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 | Baseline, 12 weeks | Change from baseline to 12 weeks in the USDA Food Security Survey. Scores range from 0-10 with higher scores indicating lower food security. |
| Percent initial weight loss | Baseline, 12 weeks | Change from baseline to 12 weeks in percent initial weight loss |
| Food addiction | Baseline, 12 weeks | 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 | Baseline, 12 weeks | Change from baseline to 12 weeks in Eating Behaviors. Higher scores indicate greater agreement. |
| Self-regulation of eating | Baseline, 12 weeks | 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 | Baseline, 12 weeks | 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 | Baseline, 12 weeks | 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 | Baseline, 12 weeks | Change from baseline to 12 weeks in scores on the International Physical Activity Questionnaire. Higher scores indicate more physical activity. |
| Perceived Stress Scale | Baseline, 12 weeks | Change from baseline to 12 weeks in scores on the Perceived Stress Scale. Scores range from 0-56 with higher scores indicating more stress. |
| Depressive symptoms | Baseline, 12 weeks | 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. |
Countries
United States
Outcome results
None listed