MyLife: A Digital Health Coaching Program

NCT03529903 | Completed

• 1 other identifier: 18-000325
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lifestyle-related Condition; Obesity; Sedentary Lifestyle; PreDiabetes; Hypertension

Keywords

behavior change; health coaching; wearable activity tracker; text messaging; lifestyle-related chronic diseases

Outcome Measures

Primary Outcomes (2)

• Change in Weight

  Weight measured using a scale

  16 weeks (measured biweekly)

• Change in Physical Activity

  Activity minutes measured using a wearable activity tracker

  16 weeks (measured biweekly)

Study Arms (2)

Control Group

NO INTERVENTION

\*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 Group

EXPERIMENTAL

\*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

Interventions

Health Coaching BEHAVIORAL

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Medicine - Pediatrics Comprehensive Care Center

Santa Monica, California, 90404, United States

Location

Related Publications (7)

• Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.

  PMID: 21513547 BACKGROUND

• Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.

  PMID: 23512568 BACKGROUND

• Dusseldorp E, van Genugten L, van Buuren S, Verheijden MW, van Empelen P. Combinations of techniques that effectively change health behavior: evidence from Meta-CART analysis. Health Psychol. 2014 Dec;33(12):1530-40. doi: 10.1037/hea0000018. Epub 2013 Nov 25.

  PMID: 24274802 BACKGROUND

• Patel MS, Asch DA, Volpp KG. Wearable devices as facilitators, not drivers, of health behavior change. JAMA. 2015 Feb 3;313(5):459-60. doi: 10.1001/jama.2014.14781. No abstract available.

  PMID: 25569175 BACKGROUND

• Godino JG, Merchant G, Norman GJ, Donohue MC, Marshall SJ, Fowler JH, Calfas KJ, Huang JS, Rock CL, Griswold WG, Gupta A, Raab F, Fogg BJ, Robinson TN, Patrick K. Using social and mobile tools for weight loss in overweight and obese young adults (Project SMART): a 2 year, parallel-group, randomised, controlled trial. Lancet Diabetes Endocrinol. 2016 Sep;4(9):747-755. doi: 10.1016/S2213-8587(16)30105-X. Epub 2016 Jul 14.

  PMID: 27426247 BACKGROUND

• Mishuris RG, Yoder J, Wilson D, Mann D. Integrating data from an online diabetes prevention program into an electronic health record and clinical workflow, a design phase usability study. BMC Med Inform Decis Mak. 2016 Jul 11;16:88. doi: 10.1186/s12911-016-0328-x.

  PMID: 27401606 BACKGROUND

• Goldman ML, Ghorob A, Eyre SL, Bodenheimer T. How do peer coaches improve diabetes care for low-income patients?: a qualitative analysis. Diabetes Educ. 2013 Nov-Dec;39(6):800-10. doi: 10.1177/0145721713505779. Epub 2013 Oct 29.

  PMID: 24168838 BACKGROUND

MeSH Terms

Conditions

Mental Disorders; Obesity; Sedentary Behavior; Prediabetic State; Hypertension

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 18, 2018
• Study Start: August 10, 2018
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

US (1)