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ObesityNCT05362747

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

A study testing Behavioral weight loss and produce vouchers in people with Obesity, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Behavioral weight loss and produce vouchers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
26 Apr 2022to 2 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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).

Read the 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.

Conditions
Obesity
Being tested
Behavioral weight loss and produce vouchers
Keywords
food insecurity
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral weight loss and produce vouchersBehavioural

    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.

Study groups in NCT05362747
Study groupRoleWhat they receive
ProduceRxExperimentalParticipants in the ProduceRx intervention group will be provided with BWL and produce vouchers for fresh fruits and vegetables.
Receives: Behavioral: Behavioral weight loss and produce vouchers
Waitlist ControlNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 12 weeks

Secondary outcomes (16)

  1. Percent initial weight loss

    Change from baseline to 12 weeks in percent initial weight loss

    Measured: Baseline, 12 weeks

  2. Systolic blood pressure

    Change from baseline to 12 weeks in systolic blood pressure

    Measured: Baseline, 12 weeks

  3. Diastolic blood pressure

    Change from baseline to 12 weeks in diastolic blood pressure

    Measured: Baseline, 12 weeks

  4. Waist circumference

    Change from baseline to 12 weeks in waist circumference

    Measured: Baseline, 12 weeks

  5. Pulse

    Change from baseline to 12 weeks in pulse rate

    Measured: Baseline, 12 weeks

  6. 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.

    Measured: Baseline, 12 weeks

  7. 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.

    Measured: Baseline, 12 weeks

  8. 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.

    Measured: Baseline, 12 weeks

  9. 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.

    Measured: Baseline, 12 weeks

  10. 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.

    Measured: Baseline, 12 weeks

  11. Eating behaviors

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

    Measured: Baseline, 12 weeks

  12. 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.

    Measured: Baseline, 12 weeks

  13. 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.

    Measured: Baseline, 12 weeks

  14. 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.

    Measured: Baseline, 12 weeks

  15. Physical activity

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

    Measured: Baseline, 12 weeks

  16. 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.

    Measured: Baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2022
  2. Study start26 Apr 2022
  3. Primary completion2 Jun 2023
  4. Study completion2 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05362747
Sponsor's protocol ID
851009
Status last verified
Jul 2023
First submitted
26 Apr 2022
Last updated
12 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral weight loss and produce vouchers in people with Obesity, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dietary quality (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05362747.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.

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