- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05635019
FoodRx for Obesity Treatment
January 4, 2024 updated by: University of Pennsylvania
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ariana M Chao, PhD, CRNP
- Phone Number: 215-746-7183
- Email: arichao@upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
-
Contact:
- Alexandra Paul
- Phone Number: 215-573-7403
- Email: Alex.Paul@Pennmedicine.upenn.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Behavioral weight loss counseling (BWL) alone
BWL counseling alone
|
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.
|
Experimental: BWL+VOUCHER
BWL counseling and gift cards to grocery stores
|
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.
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.
|
Experimental: BWL+HOME
BWL counseling and home-delivered boxes of groceries
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent initial weight loss 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 loss (percent of initial weight) at 24 weeks.
|
Change from baseline to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent initial weight loss 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.
|
Change from baseline to 24 weeks
|
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 as assessed with the Short Form-36.
Scores range from 0 (worse) to 100 (best).
|
Change from baseline to 24 weeks
|
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).
|
Change from baseline to 24 weeks
|
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
|
Change from baseline to 24 weeks
|
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).
|
Change from baseline to 24 weeks
|
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).
|
Change from baseline to 24 weeks
|
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 as assessed with the Impact of Weight on Quality of Life-Lite.
Scores range from 0 (worse) to 100 (best).
|
Change from baseline to 24 weeks
|
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
|
Change from baseline to 24 weeks
|
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).
|
Change from baseline to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2022
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
August 1, 2024
Study Registration Dates
First Submitted
November 22, 2022
First Submitted That Met QC Criteria
November 22, 2022
First Posted (Actual)
December 2, 2022
Study Record Updates
Last Update Posted (Estimated)
January 8, 2024
Last Update Submitted That Met QC Criteria
January 4, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 852467
- R56NR020466-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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