Randomized Experiment of Sleep Technology
Condition: Sleep
Study type: Interventional

Summary: 
      Short sleep duration is highly prevalent and linked to negative mental and physical health
      consequences, including increased cardiovascular disease risk [1]. According to data from the
      National Health Interview Survey, 70.1 million U.S. adults (29.2%) sleep <6 hours per 24 hour
      period [2]. These statistics are a stark contrast to recommendations made by a recent
      consensus panel of sleep experts that concluded "at least 7 hours" is the amount of sleep
      needed for health and performance among adults [3]. Therefore, a high number of U.S. adults
      could benefit from extending sleep duration. Several small experiments have demonstrated the
      benefits of short-term sleep extension [4-8]. However, these studies are limited by extending
      sleep as a temporary experimental manipulation rather than a longer-term behavioral
      intervention. To deliver sleep extension interventions, wearable sleep trackers may be
      useful, particularly given the rapid uptake among consumers (+500% in 3 years) [9]. We have
      developed a novel technology-assisted behavioral sleep extension intervention that employs
      four elements -- a wearable sleep tracker, didactic content, an interactive smartphone
      feature and brief telephone counseling. User testing supports feasibility of extending sleep,
      but little is known about the effects of differing types of technology interventions on
      sleep. Therefore, the goal of this study is to examine the differences between technology
      sleep extension interventions and sleep duration.
    

Detailed description: 
      Study Design - Intervention

        -  Web or phone prescreening: Participants will first complete a brief online screening to
           determine initial eligibility criteria (self-report of medical and psychiatric
           conditions, sleep disorders). Individuals who are potentially eligible will be sent an
           Actiwatch via FedEx, along with training instructions. Participants will wear the
           Actiwatch for a 7-day prescreening assessment. Research staff will receive verbal
           consent for this screening procedure and will go over instructions over the phone to
           ensure participants understand how to use this device.

        -  Study Visits: Visit 1- Screening assessment: Participants will attend a one hour
           laboratory visit that will include consent procedures, standardized measurements of
           height, weight, waist and hip circumference, and blood pressure. Participants will
           complete baseline study questionnaires.

        -  Enrollment: During visit 1, staff will review eligibility. Participants will be informed
           at the end of visit one of their eligibility. If the participant is eligible, they will
           receive a verbal and written instructions and informing them of their study group
           assignment. If they are not eligible, a payment will be sent via check.

        -  Randomization: Participants will be randomized to 4 study groups using sealed envelopes
           with assignments determined via a random number generator.

        -  Study Conditions: Participants will be randomly assigned to 1 of 4 study groups.

        -  Study group 1: Participants will receive the telephone coaching and wear the Fitbit
           device week 1 through week 6.

        -  Study group 2: Participants will receive the telephone coaching only.

        -  Study group 3: Participants will wear the Fitbit device week 1 through week 6 study but
           will not receive telephone coaching.

        -  Study group 4: Control group. Participants will not receive telephone coaching nor will
           they wear the Fitbit device. They will be instructed to keep their sleep schedule
           consistent.

      Arms and Interventions -

        -  The intervention will be delivered via smartphone and adherence will be facilitated by
           telephone coaching. Participants will receive weekly "lessons", which are content that
           is emailed each week as part of the program. In study groups 1 and 3, participants will
           wear a Fitbit sleep tracking monitor for the duration of the intervention. Coaches will
           be able to log in and see participants' data to help encourage them to meet their sleep
           goals.

        -  Weekly lesson content will be delivered via email (e.g. mail chimp).

        -  Telephone coaching: Participants in study groups 1 and 2 will be assigned to a sleep
           coach who will monitor their progress during the study and provide weekly telephone
           coaching sessions related to their sleep-related goals. The coaches will establish
           legitimacy by their knowledge of sleep and basic counseling principles. They will
           establish goals with the participants based on the participants' values and beliefs,
           including the particular sleep related goals and also usage goals, (e.g., number of
           log-ins completed per week). Performance monitoring will be completed through an online
           dashboard visible to the coaches (Fitbit web log in). The first coaching session is a 20
           min engagement session, which includes introductions, rational for the program,
           clarifying roles of the coach and the participants' goals for the program. Coaches
           (directed by Dr. Baron) will provide feedback to the participant based on Fitbit and
           sleep diary data. For weeks 2-6, the coach and participant will also have weekly brief
           (5-10 min) follow-up support calls to troubleshoot any problems with the application or
           Fitbit, review progress, problem solve barriers to progress, and set goals for the
           following week. In-between sessions, the coaches will be available, mostly over email,
           to troubleshoot any problems with the content or Fitbit. Frequency of text, phone, and
           email communication will be recorded.

        -  Control group: Participants assigned to the no-treatment wait list control condition
           will be told they were assigned to the wait list group, and therefore eligible to
           receive the intervention components at the end of the study. At the end of the final
           session, they will receive a Fitbit wearable fitness tracker and emails with the 6
           didactic lessons.
    

Intervention name(s): Fibit + Coaching; Coaching; Fitbit
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): This intervention is a combination of the coaching and fitbit interventions; Coaching Participants who are assigned coaching group will receive telephone coaching. Coaches follow a guide developed by Kelly Glazer Baron, Jennifer Duffecy, Kathryn Reid, and Lauren Caccamo. The first session is an approximately 30 minute engagement session, with the purpose of "getting to know" the participant to increase likelihood for participation. The end goal is to have participants express Desire, Ability, Reason, Need, Can (DARN-C) to make changes in sleep). The remainder calls (week 2-6) are follow-up calls lasting about 5 minutes. The goal of these calls is to keep participants motivated and address any issues with the Fitbit hard or software.
Participants will also receive weekly email lessons to their personal email address for 1-6 weeks.; Fitbit Participants in the fitbit group will receive a Fitbit Charge 3 black, and asked to wear it for 1-6 weeks. Participants will monitor their sleep through the sleep section in the Fitbit app on the smartphone. Participants will be provided login information so that researchers can access this data and asked to keep Bluetooth on. After week 6, participants can choose to continue to wear the device for the duration of the study (12 weeks). Though wear at weeks 7-12 is not required, researchers will still use any data that was collected from the fitbit during that time. At the completion of their participation, researchers retain the login information and the device is switched to a personal login of the participants choice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment