Skip to main content
OpenTrials
Completed

NCT Number: NCT05635019

FoodRx for Obesity Treatment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

BWL+VOUCHER

Behavioral

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+HOME

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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

    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.

Secondary outcomes

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

    Time frame: Change from baseline to 24 weeks

    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.

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

    Time frame: Change from baseline to 24 weeks

    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).

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

    Time frame: Change from baseline to 24 weeks

    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).

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

    Time frame: Change from baseline to 24 weeks

    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.

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

    Time frame: Change from baseline to 24 weeks

    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).

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

    Time frame: Change from baseline to 24 weeks

    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).

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

    Time frame: Change from baseline to 24 weeks

    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).

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

    Time frame: Change from baseline to 24 weeks

    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.

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

    Time frame: Change from baseline to 24 weeks

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2022
Registry last updated
Dec 17, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.