FitLink: Improving Weight Loss Maintenance by Using Digital Data to Provide Support and Accountability
Condition: Obesity; Overweight; Overweight and Obesity; Weight Loss
MeSH terms: Obesity; Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Gold Standard Behavior Therapy for Weight Loss; Standard Remote Behavior Therapy for Weight Loss; Digital Data Sharing Behavior Therapy for Weight Loss
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weight Loss; Obesity; Overweight; Behavioral Weight Loss