Digital Data Sharing for Weight Loss
(FitLink Trial)
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
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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Participants engage in weekly remote group meetings to initiate weight loss
Long-term Treatment
Participants continue with remote intervention including quarterly group meetings, phone calls, and text messages
Follow-up
Participants are monitored for weight, physical activity, and calorie intake
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)
Behavioral Weight Loss Treatment is already approved in United States, European Union, Canada for the following indications:
- Weight Loss
- Obesity Management
- Weight Loss
- Obesity Management
- Weight Loss
- Obesity Management