Digital Data Sharing for Weight Loss
(FitLink Trial)
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
36789How 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.
610111213Eligibility 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
+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.
+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
Participant Groups
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.
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 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Drexel UniversityPhiladelphia, PA
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Who Is Running the Clinical Trial?
Drexel UniversityLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Behavioral treatment of obesity. [2022]This review has shown that behavioral treatment is effective in inducing a 10% weight loss, which is sufficient to significantly improve health. Weight loss maintenance is challenging for most patients. Long-term outcomes have the potential to be improved through various methods including prolonging contact between patients and providers (either in the clinic or via Internet or telephone), facilitating high amounts of physical activity, or combining lifestyle modification with pharmacotherapy. Innovative programs also are being developed to disseminate behavioral approaches beyond traditional academic settings.
An automated internet behavioral weight-loss program by physician referral: a randomized controlled trial. [2022]To evaluate 3- and 6-month weight-loss outcomes achieved when physicians refer overweight/obese patients to an automated 3-month Internet-based behavioral weight-loss intervention.
Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. [2007]As many as two-thirds of adults in developed nations are overweight (body mass index (BMI)=25.0-29.9 kg/m2) or obese (BMI>or=30 kg/m2), and many of these individuals suffer from weight-related comorbidities such as hypertension, hyperlipidemia, and type II diabetes. On a more positive note, recent studies have demonstrated that losses as small as 5-10% of initial weight can improve these health complications. For example, the Diabetes Prevention Program demonstrated that a 7% reduction in initial weight, coupled with 150 min/week of physical activity, reduced the risk of developing type II diabetes by 58% compared with placebo. Behavioral treatment consistently induces weight losses in this range. This paper describes the behavioral treatment of obesity, including its short- and long-term results as well as approaches for improving the maintenance of lost weight. The terms "behavioral treatment," "lifestyle modification," and "behavioral weight control" are often used interchangeably, as they are in this paper. Lifestyle modification includes three principal components: diet, physical activity, and behavior therapy. The latter term, as applied to weight control, refers to a set of principles and techniques to help patients adopt new diet and exercise habits that can be sustained long term to promote health.
[A telemetrically-guided program for weight reduction in overweight subjects (the SMART study)]. [2017]Compliance with weight reducing programs can be improved by intensive care and control. We tested a telemetrically-guided weight reduction program in overweight and obese persons.
BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences. [2022]State-of-the-art behavioral weight loss treatment (SBT) can lead to clinically meaningful weight loss, but only 30-60% achieve this goal. Developing adaptive interventions that change based on individual progress could increase the number of people who benefit.
Sharing digital self-monitoring data with others to enhance long-term weight loss: A randomized controlled trial. [2023]Participants in behavioral weight loss (BWL) programs increasingly use digital tools to self-monitor weight, physical activity, and dietary intake. Data collected with these tools can be systematically shared with other parties in ways that might support behavior change.
Community-based behavioral weight-loss treatment: long-term maintenance of weight loss, physiological, and psychological outcomes. [2013]Obesity is a significant public health problem, and sustainable long-term treatments are needed. This study examined a community-based model of weight-loss treatment. Ninety participants were recruited from eight community organizations (mean age: 49.65 years, mean body mass index: 35.80 kg/m(2); 64% female). Treatment groups were randomly assigned to two maintenance conditions: 1) self-help continuing care, or 2) assessment-only. Both received the same initial 20-session group behavioral treatment. Those randomized to continuing care were additionally instructed to meet as self-sustaining groups for 18 months post-treatment. Weight, physiological, behavioral, and psychological outcomes were assessed at baseline, post-treatment, and at six-month and 18-month follow-up. Eighty-seven percent of participants completed treatment. Participant treatment satisfaction and therapist adherence to treatment protocol were high. No group differences or time by group interaction effects emerged. Participants achieved significant weight losses at post-treatment, with no significant weight regain at six-month or 18-month follow-up. Treatment produced sustained changes in waist circumference, cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein, insulin, eating patterns, physical activity, quality of life, and body image. A community-based treatment program may be an effective form of behavioral-weight-loss treatment for overweight/obese adults. Weight losses, along with physiological and psychological benefits, were sustained over time.
Do behavioral treatments of obesity last? A five-year follow-up investigation. [2019]Although the long-term maintenance of therapy induced behavior changes and the resulting weight loss represent critical issues in the treatment of obesity, there is a paucity of available data. The present study assessed the durability of treatment induced weight losses 5 years after treatment and the long-term adherence to treatment strategies. Thirty-six of the original 44 subjects who participated in a 10-week behavioral weight control program were interviewed in person (28), by mail (5) or reported their weights by phone (3). Results indicated that most subjects gained back a major portion of the weight they lost during treatment. The average subject had gained 11.94 lb. since treatment termination and was now 1.49 lb. heavier than when he/she entered treatment. Despite the fact that program adherence following the termination of treatment was typically low, both the number of program techniques conscientiously used and the months of conscientious technique use showed significant negative correlations with posttreatment weight gains. Subjects reported that numerous situational, social and emotional factors impacted upon their weight control efforts.
Successful weight loss maintenance: A systematic review of weight control registries. [2022]Weight loss maintenance is a major challenge for obesity treatment. Weight control registries can be useful in identifying psychological and behavioural factors that could contribute to better long-term success. The objective of this study is to describe the existing weight control registries and their participants and identify correlates of weight loss maintenance. A comprehensive search of peer-reviewed articles published until November 2018 was conducted in PubMed, Web of Science, and Scopus. Studies that reported results from weight control registries were considered. Fifty-two articles, corresponding to five registries (the United States, Portugal, Germany, Finland, and Greece), were included. Registries differed in inclusion criteria and procedures. Of 51 identified weight loss and maintenance strategies, grouped in 14 domains of the Oxford Food and Activity Behaviors taxonomy, the following were the most frequently reported: having healthy foods available at home, regular breakfast intake, increasing vegetable consumption, decreasing sugary and fatty foods, limiting certain foods, and reducing fat in meals. Increased physical activity was the most consistent positive correlate of weight loss maintenance. To our knowledge, this is the first systematic review of information about successful weight loss maintenance obtained from weight control registries. Key common influential characteristics of success were identified, which can inform future prospective studies and weight management initiatives.
Internet-based weight control: the relationship between web features and weight loss. [2018]Internet-based weight control programs have been showing promising results; however, as of yet, it is unclear which website components are critical for producing and maintaining weight loss. The aim of this study is to examine the utilization patterns of a weight control website and the relationship of the Web features to weight loss and maintenance. One hundred and twenty three (N = 123) participants took part in a 12-month behavioral weight control program over the Internet and their website utilization patterns were monitored. When examining the clustering of Web feature utilization and weight loss, the "feedback" factor (progress charts, physiological calculators, and past journals) was the best predictor of weight loss during the treatment period (baseline to 6 months), while the "social support" factor (Web chats and biographical information/e-mail addresses of participants) was the best predictor during maintenance. Weight loss in an online weight control program was related to dynamic Web features that provided feedback, support, and motivation to participants.
Recent advances in internet-delivered, evidence-based weight control programs for adults. [2021]With the explosion of Internet accessibility, online delivery offers potential for significantly greater reach of evidence-based obesity treatment programs for adults. Online behavioral weight control has been shown to produce significant weight loss, with more recent programs demonstrating larger losses and general consumer satisfaction. A growing literature indicates several program parameters that may offer greatest engagement in online obesity interventions and better weight loss outcomes, including interactive, dynamic Web site features and synchronous counselor contact, although this research is in the early stages, and a clear picture of the essential components for the most effective online obesity program remains to be determined. Further research is required to enhance weight loss outcomes, determine cost-effectiveness of Internet-delivered programs, and identify the individuals most likely to benefit from treatment in this format.
An Evaluation of a Personalized Multicomponent Commercial Digital Weight Management Program: Single-Arm Behavioral Trial. [2023]Digital behavioral weight loss programs are scalable and effective, and they provide an opportunity to personalize intervention components. However, more research is needed to test the acceptability and efficacy of personalized digital behavioral weight loss interventions.
Enhancing group-based internet obesity treatment: A pilot RCT comparing video and text-based chat. [2023]Internet delivery of behavioural weight control interventions offers potential for broad geographic reach and accessibility, but weight losses online fall short of those produced with the same programme delivered in-person. This pilot study examined feasibility and preliminary efficacy of a video-based platform for delivering weekly chat as part of a 6-month, 24-session online group behavioural weight control programme compared with the established text-based format, which has produced the best online weight losses to date.