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Completed

NCT Number: NCT05362747

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

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).

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral weight loss and produce vouchers

Behavioral

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 outcomes

  1. Dietary quality

    Time frame: 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 outcomes

  1. Percent initial weight loss

    Time frame: Baseline, 12 weeks

    Change from baseline to 12 weeks in percent initial weight loss

  2. Systolic blood pressure

    Time frame: Baseline, 12 weeks

    Change from baseline to 12 weeks in systolic blood pressure

  3. Diastolic blood pressure

    Time frame: Baseline, 12 weeks

    Change from baseline to 12 weeks in diastolic blood pressure

  4. Waist circumference

    Time frame: Baseline, 12 weeks

    Change from baseline to 12 weeks in waist circumference

  5. Pulse

    Time frame: Baseline, 12 weeks

    Change from baseline to 12 weeks in pulse rate

  6. Health-related quality of life

    Time frame: 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.

  7. Weight-related quality of life

    Time frame: 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.

  8. Food security

    Time frame: 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.

  9. Depressive symptoms

    Time frame: 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.

  10. Food addiction

    Time frame: 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.

  11. Eating behaviors

    Time frame: Baseline, 12 weeks

    Change from baseline to 12 weeks in Eating Behaviors. Higher scores indicate greater agreement.

  12. Self-regulation of eating

    Time frame: 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.

  13. Self-regulation of exercise

    Time frame: 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.

  14. Self-efficacy

    Time frame: 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.

  15. Physical activity

    Time frame: Baseline, 12 weeks

    Change from baseline to 12 weeks in scores on the International Physical Activity Questionnaire. Higher scores indicate more physical activity.

  16. Perceived Stress Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 5, 2022
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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