~80 spots leftby Jun 2026

Digital Data Sharing for Weight Loss

(FitLink Trial)

ML
Overseen byMeghan L Butryn, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Drexel University
Must not be taking: Insulin, Weight-loss drugs
Disqualifiers: Cancer, Type I diabetes, Psychosis, others
No Placebo Group
Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Adults attempting weight loss through lifestyle modification (LM) typically find maintenance of behavior change difficult. Outcomes might be improved if participants are provided with sustained sources of accountability and support and ongoing opportunities to reflect with others on goal progress. This study proposes that sharing digital data with other parties has the potential to improve long-term weight loss. The proposed study will enroll adults ("index participants") (N = 320) with overweight/obesity in a 24-month LM program and instruct them to use digital tools for self-monitoring of weight, physical activity, and eating on a daily basis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use insulin or any medication that can cause significant weight change.

What data supports the effectiveness of the treatment Behavioral Weight Loss Treatment, Lifestyle Modification, Behavioral Weight Loss Program, and related components?

Research shows that behavioral treatments can help people lose about 5-10% of their initial weight, which can improve health issues like high blood pressure and diabetes. Programs that include lifestyle changes, such as diet and exercise, and use technology for support, have been effective in helping people lose weight and maintain it.12345

Is digital data sharing for weight loss safe for humans?

The research on behavioral weight loss treatments, including digital data sharing, suggests they are generally safe for humans. Participants in these programs have shown improvements in health markers like cholesterol and blood sugar levels, and there are no reports of significant safety concerns.36789

How is the Behavioral Weight Loss Treatment unique compared to other weight loss treatments?

The Behavioral Weight Loss Treatment is unique because it uses digital tools to help people track their weight, physical activity, and diet, and it allows sharing this data with others to support behavior change. This approach leverages technology to provide feedback, support, and motivation, which can enhance long-term weight loss success.610111213

Research Team

ML

Meghan L Butryn, PhD

Principal Investigator

Drexel University

Eligibility Criteria

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.

Inclusion Criteria

I can walk two city blocks without needing to stop.
Satisfactory completion of all enrollment procedures
Has one adult friend or family member who indicates willingness to serve in a support role
See 4 more

Exclusion Criteria

I have lost 10% or more of my weight in the last 3 years and kept it off.
I have had weight loss surgery in the past.
I have lost 5% or more of my weight in the last 3 months.
See 3 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants engage in weekly remote group meetings to initiate weight loss

12 weeks
Weekly remote group meetings

Long-term Treatment

Participants continue with remote intervention including quarterly group meetings, phone calls, and text messages

21 months
Quarterly group meetings, bi-quarterly phone calls, monthly text messages

Follow-up

Participants are monitored for weight, physical activity, and calorie intake

4 weeks

Treatment Details

Interventions

  • Behavioral Weight Loss Treatment (Behavioural Intervention)
  • Coach Share Off (Behavioural Intervention)
  • Coach Share On (Behavioural Intervention)
  • Friend/Family Share Off (Behavioural Intervention)
  • Friend/Family Share On (Behavioural Intervention)
  • Group Share Off (Behavioural Intervention)
  • Group Share On (Behavioural Intervention)
Trial OverviewThe 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.
Participant Groups
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

Behavioral Weight Loss Treatment is already approved in Canada for the following indications:

🇨🇦
Approved in Canada as Behavioral Weight Loss Program for:
  • Weight Loss
  • Obesity Management

Find a Clinic Near You

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials
160
Recruited
48,600+
Nancy D. Spector profile image

Nancy D. Spector

Drexel University

Chief Medical Officer

MD from Drexel University

Denis O'Brien profile image

Denis O'Brien

Drexel University

Chief Executive Officer since 2020

MBA from Drexel University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+
Dr. Griffin P. Rodgers profile image

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers profile image

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

Behavioral treatment can effectively lead to a 10% weight loss, which is significant enough to improve health outcomes for patients.
Maintaining weight loss is difficult, but long-term success can be enhanced by increasing patient-provider contact, encouraging physical activity, and combining lifestyle changes with medication.
Behavioral treatment of obesity.Butryn, ML., Webb, V., Wadden, TA.[2022]
A study involving 154 overweight or obese patients showed that those referred to an automated Internet-based behavioral weight-loss intervention lost significantly more weight than those in an education-only control group, with average losses of 5.5 kg at 3 months and 5.4 kg at 6 months.
Over half of the participants in the Internet-based intervention achieved a clinically significant weight loss of 5% or more of their initial body weight, indicating the intervention's effectiveness in promoting weight control behaviors.
An automated internet behavioral weight-loss program by physician referral: a randomized controlled trial.Thomas, JG., Leahey, TM., Wing, RR.[2022]
Weight loss of just 5-10% can significantly improve health issues related to obesity, such as hypertension and type II diabetes, as shown in studies like the Diabetes Prevention Program, which found a 7% weight reduction reduced diabetes risk by 58%.
Behavioral treatments, which include diet changes, increased physical activity, and behavior therapy, are effective in achieving and maintaining this level of weight loss, promoting long-term health benefits.
Lifestyle modification in the treatment of obesity: an educational challenge and opportunity.Jones, LR., Wilson, CI., Wadden, TA.[2007]

References

Behavioral treatment of obesity. [2022]
An automated internet behavioral weight-loss program by physician referral: a randomized controlled trial. [2022]
Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. [2007]
[A telemetrically-guided program for weight reduction in overweight subjects (the SMART study)]. [2017]
BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences. [2022]
Sharing digital self-monitoring data with others to enhance long-term weight loss: A randomized controlled trial. [2023]
Community-based behavioral weight-loss treatment: long-term maintenance of weight loss, physiological, and psychological outcomes. [2013]
Do behavioral treatments of obesity last? A five-year follow-up investigation. [2019]
Successful weight loss maintenance: A systematic review of weight control registries. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Internet-based weight control: the relationship between web features and weight loss. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Recent advances in internet-delivered, evidence-based weight control programs for adults. [2021]
An Evaluation of a Personalized Multicomponent Commercial Digital Weight Management Program: Single-Arm Behavioral Trial. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Enhancing group-based internet obesity treatment: A pilot RCT comparing video and text-based chat. [2023]