MyLife: A Digital Health Coaching Program
Condition: Lifestyle-related Condition; Obesity; Sedentary Lifestyle; PreDiabetes; Hypertension
MeSH terms: Prediabetic State; Chronic Disease
Study type: Interventional

Summary: 
      Lifestyle behaviors such as sleep, diet, and physical activity, are implicated in a number of
      chronic conditions including hypertension, obesity, diabetes, heart failure, and obstructive
      sleep apnea. Research shows that despite awareness of this fact, patients at risk for
      lifestyle-related chronic diseases have difficulty adhering to lifestyle change
      recommendations made by their physicians, and face challenges when attempting to modify
      unhealthy behaviors. New technologies, such as wearable activity trackers and automated text
      messaging, are promising tools for monitoring and promoting healthy lifestyle behaviors among
      patients. This randomized controlled trial will evaluate the effect of a digital health
      program, which uses pre-medical post-baccalaureate or undergraduate health coaches, wearable
      activity trackers (Fitbit Charge 2), and mobile messaging, compared to wearable activity
      trackers (Fitbit Charge 2) alone in promoting lifestyle change among overweight and sedentary
      18-64 year old patients recruited from UCLA Health primary care clinics.
    

Detailed description: 
      100 overweight and sedentary patients at early risk for lifestyle-related chronic diseases
      will be recruited and receive a screening and consent survey link via the Way To Health web
      portal, https://www.waytohealth.org/. Upon reaching the portal, potential participants will
      be asked to create an account and will then be informed of the details of the study,
      including its objectives, duration, requirements, and financial payments. If participants are
      still interested in participating, the Way to Health portal will take them through an
      automated online informed consent. The consent document will be divided into sections and
      potential participants will have to click a button to advance through each section. This is
      to help ensure that participants read the consent form thoroughly by breaking down the form
      into manageable blocks of text. Successive screens will explain the voluntary nature of the
      study, the risks and benefits of participation, alternatives to participation, and that
      participants can withdraw from the study at any time. On the final consent screen, potential
      participants who click a clearly delineated button stating that they agree to participate in
      the study will be considered to have consented to enroll. After consenting, participants will
      complete an online questionnaire to determine their eligibility. Eligible participants will
      then be randomized using a computer-generated simple randomization algorithm to allocate
      patients equally (1:1) to one of the study arms (intervention and control) and will be
      directed to sign up for their intake clinic visit via an online scheduling site. Participants
      will be provided with details regarding how to contact the research team via email or phone
      at any time if they subsequently wish to withdraw from the study. This contact information
      will remain easily accessible via the participants' individual Way to Health web portal
      dashboards throughout the study. Both health coaches and patients will have portals on the
      Way To Health platform, in which surveys will be developed and completed. Health coaches will
      be able to use this portal to track patient progress, including Fitbit physical activity
      data, while patients will be able to upload pictures (and messages if they choose).
      Additionally, both automated and manual branching logic text messages will be sent by health
      coaches via this platform, while patients can respond without using the online application.

      Patients will also be required to enter their credit card or debit card information into a
      secure online service, which will be to apply fees for failure to participate in the study, a
      total maximum of $150. This information includes the full name associated with the card,
      complete card number, expiration date, security code/CVV, and billing ZIP code. All patients
      will be sent multiple participation reminders via email, text message, and phone call.
      However, patients who ultimately fail to participate in the midpoint survey (approximately 8
      weeks in the study) or the outtake survey and associated outtake visit (approximately 16
      weeks in the study) will be charged $75 or $75, respectively. Patients who complete the
      midpoint survey, outtake survey, and outtake clinic visit will be charged $0. All
      participants will be able to keep their device after the 16 week program is finished. This
      financial incentive leverages the concept of loss aversion, that "losses loom larger than
      gains" (Kahneman & Tversky, 1979), to motivate study enrollment and completion rates
      independent of study arm. Patients may be reimbursed any charge should we receive a note from
      their primary care physician justifying a medical reason for failure to participate. In
      addition, if at the end of the study the patient states that they are unable to meet the
      financial requirement, they will be given the option to return a functional Fitbit for a full
      reimbursement.

      At their intake appointment, patients will meet with study personnel, who will measure their
      baseline height, weight, and blood pressure. Participants will then complete an intake survey
      that will assess their lifestyle habits in three areas: sleep, physical activity, and
      diet/nutrition. The surveys will also assess their personal engagement in their health and
      baseline level of stress. Based on the responses to these questions, participants in the
      intervention arm will be assigned a personal health coach and receive health behavior
      counseling as well as an individualized lifestyle plan, including recommendations and
      patient-defined goals in each of the three areas. All patients enrolled into the study will
      receive a free Fitbit™ Charge 2 device during their intake visit appointment (face value of
      $150) and will be informed of the CDC/federal recommendation guidelines for physical activity
      (https://www.cdc.gov/physicalactivity/index.html) and nutrition
      (https://health.gov/dietaryguidelines/2015/guidelines/executive-summary/). Their device will
      remain free as long as they complete the intake and outtake clinic appointments and complete
      their intake, midpoint, and outtake surveys (approximate time commitment of 6 hours).

      In the intervention group patients will be asked to:

      Complete an online survey and intake appointment (about 2 hours) with a trained Health Coach,
      who will measure their height, weight, and blood pressure, assess their current health habits
      (sleep, nutrition, exercise) and work with them to set realistic, achievable health goals
      Wear and use a wearable Fitbit device every day to track their minutes of physical activity
      and weight (members of the MyLife study team can access their data during throughout the
      program and de-identified, anonymous, data will be shared with Fitbit as part of a research
      partnership) Set a weekly active minutes goal and record their weight every week Receive
      motivational text messages four times per week, including one asking for their weekly active
      minutes goal and weight and another asking for their progress toward that goal Complete photo
      food diaries every 2 weeks in which they send pictures of everything they eat or drink to
      their Health Coach Complete online surveys and telephone check-ins with their Health Coach
      (about 1 hour total) every 2 weeks to monitor their progress toward reaching their goals
      Complete a wrap-up online survey and outtake appointment with their Health Coach to re-check
      their measurements and discuss their progress (about 2 hours)

      If they are in the control group patients will be asked to:

      Complete an online survey and intake appointment (about 2 hours) with a trained Health Coach,
      who will measure their height, weight, and blood pressure, assess their current health habits
      (sleep, nutrition, exercise) and work with they to set realistic, achievable health goals
      Wear and use a wearable Fitbit device every day to track their minutes of physical activity
      and weight (members of the MyLife study team can access their data during throughout the
      program and de-identified, anonymous, data will be shared with Fitbit as part of a research
      partnership) Complete another online survey and telephone check-in with their Health Coach
      (about 1 hour total) at the halfway point to monitor their progress toward reaching their
      goals Complete a wrap-up online survey and outtake appointment with their Health Coach to
      re-check their measurements and discuss their progress (about 2 hours)
    

Intervention name(s): Health Coaching
Intervention type(s): Behavioral
Intervention description(s): Our trained health coaches will use the Way To Health platform to track patient health behaviors, and will communicate with patients via both SMS text messaging (up to four messages per week) and biweekly phone calls (up to one hour). During these interactions, health coaches will connect the patient to helpful resources and to help them reflect on previous goals and to set realistic, achievable goals for the upcoming weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: behavior change; health coaching; wearable activity tracker; text messaging; lifestyle-related chronic diseases