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MyLife: A Digital Health Coaching Program

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ClinicalTrials.gov Identifier: NCT03529903
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel M. Croymans, MD, MBA, MS, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Lifestyle-related Condition Obesity Sedentary Lifestyle PreDiabetes Hypertension Behavioral: Health Coaching Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: MyLife: A Digital Health Coaching Program Encouraging Healthy Behaviors in Patients at Risk for Lifestyle-related Chronic Diseases
Actual Study Start Date : August 10, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Group
*Complete an online survey and intake appointment with a trained Health Coach (HC), 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 a Fitbit device daily to track 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 HC at the halfway point to monitor their progress toward reaching their goals. *Complete a final online survey and outtake appointment with their HC to re-check their measurements and discuss their progress.
Experimental: Experimental Group
*Complete survey/ intake appointment with a HC, who will measure their height, weight, and blood pressure, assess their health habits and set achievable health goals. *Wear a Fitbit to track their daily physical activity and weight *Set a weekly active minutes goal and record their weight weekly. *Receive motivational text messages 4x per week, one will ask for their weekly active minutes goal and weight and another will ask for goal progression.*Complete photo food diaries biweekly (send pictures of everything they eat/drink to their HC). *Complete surveys/telephone check-ins with their HC every 2 weeks to monitor their progress toward reaching their goals. *Complete final survey/outtake appointment with their HC to for final measurements and to discuss goal progression (about 2 hours).
Behavioral: Health Coaching
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.




Primary Outcome Measures :
  1. Change in Weight [ Time Frame: 16 weeks (measured biweekly) ]
    Weight measured using a scale

  2. Change in Physical Activity [ Time Frame: 16 weeks (measured biweekly) ]
    Activity minutes measured using a wearable activity tracker



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529903


Contacts
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Contact: Daniel M Croymans, MD, MBA, MS 310-825-7375 dcroymans@mednet.ucla.edu

Locations
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United States, California
UCLA Medicine - Pediatrics Comprehensive Care Center Recruiting
Santa Monica, California, United States, 90404
Contact: Daniel M Croymans, MD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Alice Kuo, MD, PhD, MBA Chief of Medicine-Pediatrics, UCLA Health
Principal Investigator: Daniel M Croymans, MD, MBA, MS Department of Medicine, UCLA Health
Principal Investigator: Paul J Bixenstine, MD Department of Medicine and Department of Pediatrics, UCLA Health

Publications:

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Responsible Party: Daniel M. Croymans, MD, MBA, MS, Co-Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03529903     History of Changes
Other Study ID Numbers: 18-000325
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniel M. Croymans, MD, MBA, MS, University of California, Los Angeles:
behavior change
health coaching
wearable activity tracker
text messaging
lifestyle-related chronic diseases

Additional relevant MeSH terms:
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Chronic Disease
Prediabetic State
Mental Disorders
Disease Attributes
Pathologic Processes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases