FitLink: Improving Weight Loss Maintenance by Using Digital Data to Provide Support and Accountability

Study Overview
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Brief Summary
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Most adults in the U.S. are overweight or obese and find maintenance of weight loss difficult. This study is designed to aid in the development of a lifestyle modification program that can facilitate weight loss maintenance, without requiring long-term visits to a clinic for maintenance treatment.

Detailed Description
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In a lifestyle modification program, contact with an interventionist (e.g., weight loss coach) creates a sense of supportive accountability that can facilitate behavior change and weight loss. Sustaining a strong sense of supportive accountability after face-to-face intervention contact ends has the potential to improve outcomes during the notoriously difficult weight loss maintenance period. One innovative way of facilitating supportive accountability is providing participants with digital tools that objectively measure weight and physical activity and track food intake in real-time, making the data from those tools automatically and continuously available to coaches, and designing the timing and content of intervention contacts such that they are responsive to the shared data. Although tools that allow for data sharing from sensors and Internet-based applications are readily available, the ways in which they are integrated into intervention contacts in a lifestyle modification program are not yet optimized, and research has not systematically evaluated the effect of data sharing on behavior. Overweight and obese participants (n = 90) will be recruited from the community for a small randomized controlled trial in order to test the feasibility, acceptability, efficacy, and mechanisms of action of a lifestyle modification intervention enhanced with data sharing. In weeks 1-12 of the program (i.e., Phase I), all participants will attend 12 weekly, face-to-face, group-based behavioral treatment sessions to induce weight loss. Participants will be provided with a wireless body weight scale, physical activity sensor, and digital food record app and instructed to use them daily use for self-monitoring purposes. In Phase II (weeks 13-52), participants will be randomly assigned to the standard (LM) or enhanced version of remote lifestyle modification (LM+SHARE). Neither condition will have face-to-face intervention contact during Phase II; remote intervention contact will consist of brief phone calls and text messages provided by the participant's coach. Participants in both conditions will be prescribed continued daily use of the three self-monitoring devices. In the standard LM condition, no digital data from these devices will be directly shared with coaches; intervention encounters will be informed only by the infrequent, delayed self-report of participants (which is the current standard of long-term obesity care), and timing of text messages will be fixed. In LM+SHARE, the digital tools will automatically and continuously transmit body weight, physical activity, and food record data to the coach. In LM+SHARE, supportive accountability will be enhanced in three ways: 1) participants will receive automated alerts after coaches view their data, 2) timing of personalized text messages from coaches will be responsive to clinically notable change in weight, physical activity, calorie intake, or use of scale, physical activity sensor, or food record tool, and 3) content of the text messages and phone calls will be informed by the digital data the coach has viewed, as well as the expectation that the coach will continue viewing data in order to provide ongoing support. Assessments will be completed at 0, 12, 26, and 52 weeks.

Official Title
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Improving Weight Loss Maintenance by Using Digital Data Sharing to Provide Responsive Support and Accountability

Conditions
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Weight Loss, Obesity, Overweight, Overweight and Obesity

Intervention / Treatment
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* Behavioral: Gold Standard Behavior Therapy for Weight Loss
* Behavioral: Standard Remote Behavior Therapy for Weight Loss
* Behavioral: Digital Data Sharing Behavior Therapy for Weight Loss


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 18-70 years with a BMI of 25-45 kg/m2 and weight <160 kg Access to a smartphone Satisfactory completion of all enrollment procedures Ability to engage in physical activity (i.e. can walk at least 2 blocks without stopping for rest) Exclusion Criteria: Medical condition (i.e. acute coronary syndrome, type 1 diabetes, renal failure) or psychiatric condition (i.e. active substance abuse, eating disorder) that may: Pose a risk to the participant during the intervention Cause a change in weight Limit ability to comply with the behavioral recommendations of the program Pregnant or planning pregnancy in the next 1 year Planned move out of the Philadelphia area during the data collection period Use of a pacemaker (incompatible with wireless scale technology) Recently began or changed the dosage of a medication that can cause significant change in weight History of bariatric surgery Weight loss of > 10% in the previous 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lifestyle Modification<br>Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report. | Behavioral: Gold Standard Behavior Therapy for Weight Loss<br>* Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.<br>Behavioral: Standard Remote Behavior Therapy for Weight Loss<br>* Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.<br>|
| Experimental: Lifestyle Modification + Share<br>Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians. | Behavioral: Gold Standard Behavior Therapy for Weight Loss<br>* Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.<br>Behavioral: Digital Data Sharing Behavior Therapy for Weight Loss<br>* Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight | Objectively measured in the research clinic at each time point on a scale. Reported as weight change in kg, where negative numbers reflect weight loss and positive numbers reflect weight gain. | 0, 13, 26, 52 weeks | 
| Change in Physical Activity | Objectively measured using wGT3X-BT accelerometers from Actigraph. Minutes/week of moderate-to-vigorous physical activity (MVPA). | 13, 52 weeks | 
| Number of Participants Retained | Feasibility and acceptability metric of retention. | 26, 52 weeks | 
| Number of Completed Treatment Contacts | Feasibility and acceptability metric of completed treatment contacts (phone calls and text messages). | 52 weeks | 
| Treatment Acceptability Questionnaire (TAQ) | Feasibility and acceptability metric of scores on the TAQ. Items on the TAQ consisted of 11 questions on a 7 point Likert scale asking about helpfulness and acceptability of treatment components. Items are summed to yield a total score that can range from 11-77 with higher numbers indicated higher acceptability. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-monitoring Engagement | Use of digital devices; percent of days during which weight, food, and steps were counted in Phase II. Percent calculated for each group (LM vs. LM+Share) and not for individual participants. We determined percent to be the metric that would be most easily interpreted and it accounted for any possible variability in total number of days of observations. | 13-52 weeks | 
| Perceived Accountability | Change in Perceptions of Accountability subscale of the Supportive Accountability Scale. The measure used was a 10-item scale on which participants rated the extent to which they agreed with statements on a 7-point likert scale. A total score was generated by summing scores from individual items. Total scores ranged from 10-70 with higher scorings indicating higher perceived accountability. The outcome measure reported here is the change in total score on this measure (decrease) across Phase II where a negative score reflects a decrease in perceived accountability. | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss, Obesity, Overweight, Behavioral Weight Loss