Clinical trial NCT03529903: MyLife: A Digital Health Coaching Program
Official title: MyLife: A Digital Health Coaching Program Encouraging Healthy Behaviors in Patients at Risk for Lifestyle-related Chronic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lifestyle-related Condition
Obesity
Sedentary Lifestyle
PreDiabetes
Hypertension
Keywords: behavior change
health coaching
wearable activity tracker
text messaging
lifestyle-related chronic diseases
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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)

Eligibility criteria: Inclusion Criteria:

* Age 18-64
* English speaking
* Owns a smartphone with texting capabilities.
* BMI \>= 27
* Desire to lose weight and increase physical activity.
* Sedentary behavior (defined as less than 150 minutes per week of moderate to vigorous physical activity (MVPA)).
* Have a UCLA Health Primary Care Physician (PCP) and their PCP's agreement to enroll in the study.

Exclusion Criteria:

* Age \<18 or \> 65
* Does not own a smart-phone
* Currently using a wearable device that tracks physical activity and sleep
* Poorly controlled diabetes mellitus, defined by, but not limited to: o Most recent HbA1c \>9 o Diabetic neuropathy that has led to osteomyelitis and/or amputation
* Chronic kidney disease (CKD) grade III or higher OR dialysis dependent
* Chronic heart failure (CHF) stage II or higher
* Unable to participate in physical activity due to chronic medical condition, including, but not limited to: o Severe/advanced joint arthritis o Unstable angina o History of NSTEMI (non-ST elevation myocardial infarction), STEMI (ST elevation myocardial infarction) or stroke in past 12 months oActive cancer undergoing chemotherapy or radiation oActive substance abuse or alcoholism
* Current participation in organized exercise program on a regular or repeated basis defined as coaching sessions at a frequency greater than 4 times per month (ie- Weight Watchers, personalized coaching for nutrition/personal training, and/or cardiac or stroke rehab)
* Any health condition that would limit life expectancy to less than 1 year
* Any additional health condition including cognitive dysfunction, mental health, or physical condition that would prevent patient from participating fully in activity and/or health coaching as defined by their primary care provider (PCP).
* Currently enrolled in any research studies that may influence your physical activity, food and beverage choices, or bodyweight
* Lost more than 10 lbs in the last 3 months

Primary outcomes:
measure: Change in Weight
timeFrame: 16 weeks (measured biweekly)
measure: Change in Physical Activity
timeFrame: 16 weeks (measured biweekly)
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: UCLA Medicine - Pediatrics Comprehensive Care Center
state: California
Study officials:
affiliation: Chief of Medicine-Pediatrics, UCLA Health
name: Alice Kuo, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medicine, UCLA Health
name: Daniel M Croymans, MD, MBA, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medicine and Department of Pediatrics, UCLA Health
name: Paul J Bixenstine, MD
role: PRINCIPAL_INVESTIGATOR
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