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Digital Data Sharing for Weight Loss (FitLink Trial)
N/A
Recruiting
Led By Meghan L Butryn, PhD
Research Sponsored by Drexel University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to engage in physical activity (defined as walking two city blocks without stopping)
English Speaking
Must not have
Weight loss of greater than or equal to 10% in the past 3 years that is currently being maintained
History of bariatric surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12, 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether adults trying to lose weight through lifestyle modification find it easier to maintain their behavior changes when they share digital data with other parties.
Who is the study for?
This trial is for adults aged 18-70 with a BMI of 27-50, willing to use digital tools for self-monitoring weight, activity, and eating. Participants need internet access, a supportive friend or family member, and the ability to walk two city blocks. Exclusions include pregnancy, bariatric surgery history, certain medical conditions like type I diabetes or psychosis, recent significant weight loss or medication that affects weight.
What is being tested?
The study tests if sharing digital data on weight loss activities with friends/family members or coaches enhances long-term results in a lifestyle modification program. It involves using apps to track daily habits over 24 months among adults struggling with obesity.
What are the potential side effects?
Since this trial focuses on lifestyle changes and not medications, side effects are minimal but may include potential stress from constant monitoring and social pressure due to sharing personal progress with others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk two city blocks without needing to stop.
Select...
I speak English.
Select...
I am between 18 and 70 years old.
Select...
My BMI is between 27 and 50, indicating I am overweight or obese.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have lost 10% or more of my weight in the last 3 years and kept it off.
Select...
I have had weight loss surgery in the past.
Select...
I have lost 5% or more of my weight in the last 3 months.
Select...
I am taking insulin or medication that can significantly change my weight.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 12, 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12, 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Weight
Secondary study objectives
Calorie Intake
Physical Activity
Other study objectives
Coach characteristics
Demographic variables
Friend/family characteristics
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: Coach Share On + Group Share On + Friend/Family Share OnExperimental Treatment4 Interventions
Group II: Coach Share On + Group Share On + Friend/Family Share OffExperimental Treatment4 Interventions
Group III: Coach Share On + Group Share Off + Group Share OffExperimental Treatment4 Interventions
Group IV: Coach Share On + Group Share Off + Friend/Family Share OnExperimental Treatment4 Interventions
Group V: Coach Share Off + Group Share On + Friend/Family Share OnExperimental Treatment4 Interventions
Group VI: Coach Share Off + Group Share On + Friend/Family Share OffExperimental Treatment4 Interventions
Group VII: Coach Share Off + Group Share Off + Friend/Family Share OnExperimental Treatment4 Interventions
Group VIII: Coach Share Off + Group Share Off + Friend/Family Share OffExperimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Weight Loss Treatment
2002
Completed Phase 4
~470
Find a Location
Who is running the clinical trial?
Drexel UniversityLead Sponsor
155 Previous Clinical Trials
47,902 Total Patients Enrolled
30 Trials studying Obesity
6,297 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,099 Total Patients Enrolled
469 Trials studying Obesity
589,691 Patients Enrolled for Obesity
Meghan L Butryn, PhDPrincipal InvestigatorDrexel University
1 Previous Clinical Trials
62 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can walk two city blocks without needing to stop.I speak English.I have lost 10% or more of my weight in the last 3 years and kept it off.I am between 18 and 70 years old.I have had weight loss surgery in the past.I have lost 5% or more of my weight in the last 3 months.I am taking insulin or medication that can significantly change my weight.I do not have any health or mental conditions that could risk my safety or affect my weight during the study.My BMI is between 27 and 50, indicating I am overweight or obese.
Research Study Groups:
This trial has the following groups:- Group 1: Coach Share Off + Group Share Off + Friend/Family Share On
- Group 2: Coach Share Off + Group Share Off + Friend/Family Share Off
- Group 3: Coach Share On + Group Share Off + Friend/Family Share On
- Group 4: Coach Share On + Group Share Off + Group Share Off
- Group 5: Coach Share On + Group Share On + Friend/Family Share On
- Group 6: Coach Share Off + Group Share On + Friend/Family Share Off
- Group 7: Coach Share On + Group Share On + Friend/Family Share Off
- Group 8: Coach Share Off + Group Share On + Friend/Family Share On
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.
Obesity Patient Testimony for trial: Trial Name: NCT05180448 — N/A
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