Digital Data Sharing for Weight Loss

(FitLink Trial)

Overseen By Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Must not be taking: Insulin, Weight-loss drugs

Disqualifiers: Cancer, Type I diabetes, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

320 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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. ^{6 10 11 12 13}

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.

Research Team

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

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.

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
• Coach Share Off
• Coach Share On
• Friend/Family Share Off
• Friend/Family Share On
• Group Share Off
• Group Share On

Trial Overview 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.

Participant Groups

Group I: Coach Share On + Group Share On + Friend/Family Share On Experimental Treatment 4 Interventions

Group II: Coach Share On + Group Share On + Friend/Family Share Off Experimental Treatment 4 Interventions

Group III: Coach Share On + Group Share Off + Group Share Off Experimental Treatment 4 Interventions

Group IV: Coach Share On + Group Share Off + Friend/Family Share On Experimental Treatment 4 Interventions

Group V: Coach Share Off + Group Share On + Friend/Family Share On Experimental Treatment 4 Interventions

Group VI: Coach Share Off + Group Share On + Friend/Family Share Off Experimental Treatment 4 Interventions

Group VII: Coach Share Off + Group Share Off + Friend/Family Share On Experimental Treatment 4 Interventions

Group VIII: Coach Share Off + Group Share Off + Friend/Family Share Off Experimental Treatment 4 Interventions

Behavioral Weight Loss Treatment is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Behavioral Weight Loss Treatment for:

• Weight Loss
• Obesity Management

Approved in European Union as Lifestyle Modification for:

• Weight Loss
• Obesity Management

Approved in Canada as Behavioral Weight Loss Program for:

• Weight Loss
• Obesity Management

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. Jones, LR., Wilson, CI., Wadden, TA.[2007]

A telemetrically-guided weight reduction program significantly helped 200 overweight and obese participants lose an average of 6.7 kg and reduce body fat by 5.1 kg over the first six months, along with improvements in metabolic and cardiovascular risk markers.

Participants who continued with telemonitoring maintained their weight loss and health improvements, while those without telemonitoring support experienced weight regain and worsening health metrics, highlighting the efficacy of ongoing support in weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A telemetrically-guided program for weight reduction in overweight subjects (the SMART study)]. Körtke, H., Frisch, S., Zittermann, A., et al.[2017]

In a study involving 468 adults with obesity, participants who switched to portion-controlled meals (PCM) after being identified as suboptimal responders to standard behavioral weight loss treatment (SBT) lost more weight at 6 months compared to those who switched to acceptance-based treatment (ABT), although the difference was not statistically significant.

Identifying suboptimal responders as early as Session 3 of treatment led to greater weight loss in those switched to PCM compared to those identified later, suggesting that early intervention may enhance the effectiveness of weight loss strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences. Sherwood, NE., Crain, AL., Seburg, EM., et al.[2022]

The study will involve adults aged 18 to 70 with overweight or obesity, using digital tools for self-monitoring in a 24-month behavioral weight loss program aimed at achieving and maintaining a 10% weight loss.

It will explore the effectiveness of different data sharing partnerships (with coaches, group members, and friends/family) on long-term weight loss, potentially revealing how these interactions can enhance weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sharing digital self-monitoring data with others to enhance long-term weight loss: A randomized controlled trial. Miller, NA., Ehmann, MM., Hagerman, CJ., et al.[2023]

A community-based weight-loss treatment program involving 90 participants led to significant weight loss and sustained health improvements, including reductions in waist circumference and cholesterol levels, over an 18-month period.

Participants maintained their weight loss without significant regain at follow-ups, demonstrating the effectiveness of the program in promoting long-term behavioral and psychological benefits for overweight and obese adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based behavioral weight-loss treatment: long-term maintenance of weight loss, physiological, and psychological outcomes. Latner, JD., Ciao, AC., Wendicke, AU., et al.[2013]

In a study of 36 participants who completed a 10-week behavioral weight control program, most individuals regained a significant amount of weight, averaging 11.94 pounds, and were, on average, heavier than their starting weight after 5 years.

Low adherence to the treatment program after it ended was common, but those who consistently used more program techniques and for longer periods experienced less weight regain, highlighting the importance of ongoing commitment to weight management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do behavioral treatments of obesity last? A five-year follow-up investigation. Stalonas, PM., Perri, MG., Kerzner, AB.[2019]

A systematic review of 52 articles from five different weight control registries identified key strategies for successful weight loss maintenance, including having healthy foods at home, regular breakfast intake, and increased vegetable consumption.

Increased physical activity was consistently linked to better weight loss maintenance, highlighting its importance in long-term obesity treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful weight loss maintenance: A systematic review of weight control registries. Paixão, C., Dias, CM., Jorge, R., et al.[2022]

In a 12-month online weight control program with 123 participants, the use of feedback features like progress charts and journals was the strongest predictor of weight loss in the first 6 months.

For maintaining weight loss, social support features such as web chats and participant connections were most effective, highlighting the importance of both feedback and community in successful weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based weight control: the relationship between web features and weight loss. Krukowski, RA., Harvey-Berino, J., Ashikaga, T., et al.[2018]

Online behavioral weight control programs have been effective in producing significant weight loss in adults, with newer programs showing even larger losses and higher consumer satisfaction.

Key features that may enhance engagement and outcomes in online obesity interventions include interactive website elements and real-time counselor support, though more research is needed to identify the most effective components and assess cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in internet-delivered, evidence-based weight control programs for adults. Krukowski, RA., West, DS., Harvey-Berino, J.[2021]

In a 6-month trial involving 153 adults with overweight and obesity, a personalized digital weight loss program (WeightWatchers) led to an average weight loss of 5.05% from baseline, with 51% of participants achieving at least a 5% weight loss, indicating its efficacy.

Participants reported high satisfaction and engagement with the program, with significant improvements in various health-related behaviors, including increased fruit and vegetable intake, physical activity, and better sleep quality, suggesting the program's positive impact on overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of a Personalized Multicomponent Commercial Digital Weight Management Program: Single-Arm Behavioral Trial. Pagoto, S., Xu, R., Bullard, T., et al.[2023]

In a pilot study involving 32 women with obesity, those who participated in weekly video chat sessions for a 6-month online weight control program lost more weight (-5.0%) compared to those in a text-based format (-3.0%), although the difference was not statistically significant.

Participants in the video chat condition showed significantly greater engagement with the program, including better self-monitoring and website utilization, suggesting that video delivery may enhance treatment adherence and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing group-based internet obesity treatment: A pilot RCT comparing video and text-based chat. West, DS., Stansbury, M., Krukowski, RA., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Behavioral treatment of obesity. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

An automated internet behavioral weight-loss program by physician referral: a randomized controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. [2007]

4. Germany pubmed.ncbi.nlm.nih.gov

[A telemetrically-guided program for weight reduction in overweight subjects (the SMART study)]. [2017]

5. England pubmed.ncbi.nlm.nih.gov

BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Sharing digital self-monitoring data with others to enhance long-term weight loss: A randomized controlled trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Community-based behavioral weight-loss treatment: long-term maintenance of weight loss, physiological, and psychological outcomes. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Do behavioral treatments of obesity last? A five-year follow-up investigation. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Successful weight loss maintenance: A systematic review of weight control registries. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Internet-based weight control: the relationship between web features and weight loss. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Recent advances in internet-delivered, evidence-based weight control programs for adults. [2021]

12. Canada pubmed.ncbi.nlm.nih.gov

An Evaluation of a Personalized Multicomponent Commercial Digital Weight Management Program: Single-Arm Behavioral Trial. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Enhancing group-based internet obesity treatment: A pilot RCT comparing video and text-based chat. [2023]