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ObesityNCT05635019

FoodRx for Obesity Treatment

A study testing BWL+VOUCHER, BWL+HOME and Behavioral weight loss counseling (BWL) in people with Obesity and Food Insecurity, 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 study is a 3-group, parallel design, randomized controlled trial (RCT) in 105 adults with obesity and food insecurity that will compare BWL-Alone (including standard-of-care referral and connection with community food resources; n=35) to BWL plus food supplementation with either food vouchers (BWL+VOUCHER; n=35)… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity, Food Insecurity
What is being tested?
BWL+VOUCHER, BWL+HOME and Behavioral weight loss counseling (BWL)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteUnited States
Study dates
1 Dec 2022to 1 Jul 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Age >18 years
  • BMI >30 kg/m2 at screening visit
  • Screening positive for food insecurity using a score of >3 on the 10-item US Adult Food Security Survey Module109
  • Completion of baseline assessments
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  • Ability to engage in physical activity (i.e., can walk at least 2 blocks)
  • Willing and able to provide pictures of food receipts to study team (or mail actual receipts)
  • Ability to reliably receive packages at a consistent location in a timely manner
  • Telephone or internet service to communicate with study staff
  • For females of reproductive potential: agreement to use of highly effective contraception for during study participation

Who cannot join

  • Serious medical conditions (e.g., type 1 or type 2 diabetes, renal failure) that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the program's behavioral recommendations
  • Significant psychiatric conditions (e.g., active substance abuse, schizophrenia) that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the program's behavioral recommendations
  • Breastfeeding, pregnant or planning pregnancy in the next 6 months
  • Planned move from the Philadelphia area in the next 6 months
  • Weight loss of >5 kg in the previous 90 days
  • Recently began a course of or changed the dosage of medication that can cause significant weight change (±5 kg)
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  • Previous or planned obesity treatment with surgery (excluding lap band if removed for >1 year) or a weight-loss device
  • Use of prescription or over the counter medications for chronic weight management in the past 3 months
  • Household member already participating in study due to potential contamination effects
  • Lack of stable residence and ability to store and prepare food

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

Official title: Food Supplementation Interventions to Improve Weight Loss for Adults With Food Insecurity and Obesity

This study is a 3-group, parallel design, randomized controlled trial (RCT) in 105 adults with obesity and food insecurity that will compare BWL-Alone (including standard-of-care referral and connection with community food resources; n=35) to BWL plus food supplementation with either food vouchers (BWL+VOUCHER; n=35) or home-delivered, medically tailored groceries consistent with BWL recommendations (BWL+HOME; n=35). All groups will have BWL treatment provided for 24 weeks per clinical guidelines. Food vouchers and HOME will be provided for 24 weeks of treatment. Assessments will be conducted at baseline, and weeks 12 and 24.

Being tested
BWL+VOUCHER, BWL+HOME, Behavioral weight loss counseling (BWL)
Keywords
obesity, food insecurity, weight loss
Medical subject headings
Obesity, Weight Loss

What participants receive

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

  • BWL+VOUCHERBehavioural

    This group will receive the BWL program as well as food vouchers, in the form of grocery store gift cards. Participants will be allowed to select to receive gift cards to a grocery store or supermarket from a pre-determined list of stores. Gift cards worth $40 will be emailed or mailed to every 2 weeks after the BWL session.

  • BWL+HOMEBehavioural

    This group will receive the BWL program as well as home-delivered boxes of groceries of low-energy density foods conducive to weight management guidelines. Groceries will include shelf-stable and perishable products like lean meats, fresh vegetables, and fruits. Every 2 weeks, participants assigned to this group will be allowed to select a choice of one of 4 boxes with slightly varied contents. Each box will have approximately $40 worth of groceries.

  • Behavioral weight loss counseling (BWL)Behavioural

    The behavioral weight loss program consists of 14 individual lifestyle counseling sessions provided over 24 weeks. Each session will be approximately 15-20 minutes. Visits will be scheduled weekly for the first 4 weeks (weeks 1, 2, 3, and 4) and every-other week from weeks 6-24 (weeks 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24). The sessions will provide behavioral, dietary, and physical counseling.

Study groups in NCT05635019
Study groupRoleWhat they receive
Behavioral weight loss counseling (BWL) aloneActive comparatorBWL counseling alone
Receives: Behavioral: Behavioral weight loss counseling (BWL)
BWL+VOUCHERExperimentalBWL counseling and gift cards to grocery stores
Receives: Behavioral: BWL+VOUCHER; Behavioral: Behavioral weight loss counseling (BWL)
BWL+HOMEExperimentalBWL counseling and home-delivered boxes of groceries
Receives: Behavioral: BWL+HOME; Behavioral: Behavioral weight loss counseling (BWL)

What is being measured

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

  1. Percent Change in Total Body Weight at 24 Weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone)

    Comparison of BWL+VOUCHER and BWL+HOME vs BWL-Alone in weight change (percent of initial weight) at 24 weeks. Positive numbers represent increases and negative numbers represent decreases.

    Measured: Change from baseline to 24 weeks

Secondary outcomes (9)

  1. Percent Change in Total Body Weight at 24 Weeks (BWL+HOME vs BWL+VOUCHER)

    Comparison of BWL+HOME vs BWL+VOUCHER in weight loss (percent of initial weight) at 24 weeks. Negative values indicate losses. Positive values indicate gains.

    Measured: Change from baseline to 24 weeks

  2. General Health-related Quality of Life (BWL+VOUCHER and BWL+HOME vs BWL-Alone)

    Change from baseline to week 24 in general health-related quality of life (physical function component score) as assessed with the Short Form-36. Scores range from 0 (worse) to 100 (best).

    Measured: Change from baseline to 24 weeks

  3. Weight-related Quality of Life (BWL+VOUCHER and BWL+HOME vs BWL-Alone)

    Change from baseline to week 24 in weight-related quality of life as assessed with the Impact of Weight on Quality of Life-Lite. Scores range from 0 (worse) to 100 (best).

    Measured: Change from baseline to 24 weeks

  4. Dietary Quality as Assessed by Skin Carotenoid Levels (BWL+VOUCHER and BWL+HOME vs BWL-Alone)

    Change from baseline to week 24 in skin carotenoid levels (skin carotenoids are measured on a scale from 0-800). Lower scores are worse and higher scores indicate a better outcome.

    Measured: Change from baseline to 24 weeks

  5. Dietary Quality as Assessed by the Healthy Eating Index (BWL+VOUCHER and BWL+HOME vs BWL-Alone)

    Change from baseline to week 24 in Healthy Eating Index scores as measured with the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. Scores range from 0 (worse) to 100 (best).

    Measured: Change from baseline to 24 weeks

  6. General Health-related Quality of Life (BWL+VOUCHER vs BWL+HOME)

    Change from baseline to week 24 in general health-related quality of life as assessed with the Short Form-36. Scores range from 0 (worse) to 100 (best).

    Measured: Change from baseline to 24 weeks

  7. Weight-related Quality of Life (BWL+VOUCHER vs BWL+HOME)

    Change from baseline to week 24 in weight-related quality of life (physical component scale) as assessed with the Impact of Weight on Quality of Life-Lite. Scores range from 0 (worse) to 100 (best).

    Measured: Change from baseline to 24 weeks

  8. Dietary Quality as Assessed by Skin Carotenoid Levels (BWL+VOUCHER vs BWL+HOME)

    Change from baseline to week 24 in skin carotenoid levels (skin carotenoids are measured on a scale from 0-800). Lower scores are worse and higher scores indicate a better outcome.

    Measured: Change from baseline to 24 weeks

  9. Dietary Quality as Assessed by the Healthy Eating Index (BWL+VOUCHER vs BWL+HOME)

    Change from baseline to week 24 in Healthy Eating Index scores as measured with the ASA24. Scores range from 0 (worse) to 100 (best).

    Measured: Change from baseline to 24 weeks

Timeline

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

  1. First posted2 Dec 2022
  2. Study start1 Dec 2022
  3. Primary completion1 Jul 2024
  4. Study completion1 Jul 2024

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
Model description
Randomized clinical trial
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05635019
Sponsor's protocol ID
852467
Other IDs
R56NR020466-01
Status last verified
Dec 2025
First submitted
22 Nov 2022
Last updated
17 Dec 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing BWL+VOUCHER, BWL+HOME and Behavioral weight loss counseling (BWL) in people with Obesity and Food Insecurity, 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 11 inclusion and 10 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 17 Dec 2025. 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?

Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change in Total Body Weight at 24 Weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone) (time frame: Change from baseline to 24 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 NCT05635019.

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 17 Dec 2025.

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