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Behavioral Weight Loss Counseling + Support for Obesity
N/A
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 24 weeks
Awards & highlights
Study Summary
This trial will compare weight loss and food security outcomes in 105 adults with obesity and food insecurity who receive diet & exercise advice and may also receive food vouchers or home-delivered groceries. Assessments at 3 points.
Who is the study for?
This trial is for adults over 18 with obesity and food insecurity who can exercise a bit (like walking two blocks), are willing to use effective birth control if needed, and can take photos or send their food receipts. They should be able to get packages reliably, have phone or internet access, and not plan on moving from Philadelphia soon.Check my eligibility
What is being tested?
The study tests three ways to help people lose weight: standard Behavioral Weight Loss counseling (BWL), BWL plus food vouchers (BWL+VOUCHER), and BWL with home-delivered groceries matching the diet advice (BWL+HOME). Each group will follow their program for 24 weeks with check-ins at baseline, week 12, and week 24.See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include typical responses to dieting such as hunger pangs, cravings or digestive changes. Physical activity might cause muscle soreness in those unaccustomed to exercise.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent initial weight loss at 24 weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone)
Secondary outcome measures
Dietary quality as assessed by skin carotenoid levels (BWL+VOUCHER and BWL+HOME vs BWL-Alone)
Dietary quality as assessed by skin carotenoid levels (BWL+VOUCHER vs BWL+HOME)
Dietary quality as assessed by the Healthy Eating Index (BWL+VOUCHER and BWL+HOME vs BWL-Alone)
+6 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: BWL+VOUCHERExperimental Treatment2 Interventions
BWL counseling and gift cards to grocery stores
Group II: BWL+HOMEExperimental Treatment2 Interventions
BWL counseling and home-delivered boxes of groceries
Group III: Behavioral weight loss counseling (BWL) aloneActive Control1 Intervention
BWL counseling alone
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Who is running the clinical trial?
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,456 Total Patients Enrolled
16 Trials studying Obesity
3,357 Patients Enrolled for Obesity
University of PennsylvaniaLead Sponsor
2,004 Previous Clinical Trials
42,882,044 Total Patients Enrolled
87 Trials studying Obesity
72,362 Patients Enrolled for Obesity
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had or am planning to have obesity surgery, excluding lap band removed over a year ago.I am willing and able to follow the study rules and attend all appointments.I have used medication for weight management in the last 3 months.I can send or mail pictures of my food receipts to the study team.You have a high score (more than 3) on a food security survey which suggests that you may not have consistent access to enough food.I have lost more than 5 kg in the last 3 months.I am older than 18 years.I recently started or changed the dose of a medication that can significantly affect my weight.I have a serious health condition that could affect my participation or results.I can walk at least 2 blocks without help.
Research Study Groups:
This trial has the following groups:- Group 1: Behavioral weight loss counseling (BWL) alone
- Group 2: BWL+VOUCHER
- Group 3: BWL+HOME
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total number of subjects under observation in this experiment?
"Affirmative. Clinicaltrials.gov has verified that this clinical trial, initially published on December 1st 2022, is currently seeking participants. Across one medical site, 105 individuals are needed to take part in the study."
Answered by AI
Are there any vacancies in this clinical trial that would be made available to patients?
"As indicated on clinicaltrials.gov, the recruitment process for this trial is currently underway. It was first listed on December 1st 2022 and updated recently on December 19th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I just recently started a weight loss journey but food is so expensive and I always wanted to try meals.
PatientReceived no prior treatments
How responsive is this trial?
Most responsive sites:
- University of Pennsylvania: < 48 hours
Average response time
- < 2 Days
Typically responds via
Phone Call
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