Clinical trial NCT03720327: The Effects of a Mobile Health Intervention and Health Coach Text Messaging on Cardiovascular Risk of Older Adults
Official title: Fitness Intensive Therapy (Get FIT) to Promote Healthy Living in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Cardiovascular Risk Factor
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 54
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two groups for the study duration (3 months):

1. control group (Get FIT);
2. intervention group (Get FIT+).
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study, "Fitness Intensive Therapy (Get FIT) to Promote Healthy Living in Older Adults", will test a mobile-health based intervention which includes use of a Fitbit activity tracker for 3 months, a smartphone application that tracks daily food intake, and one 45 minute counseling session to create personal goals and provide patient education by a health coach; versus Get FIT+ (the same items) plus personalized text messages focusing on participant's activity and nutrition progress as monitored in the app, from the health coach for 3 months. The investigators will measure the impact on participant's diet, physical activity, clinical outcomes, psychosocial well-being, and engagement.

Detailed description: This study, "Fitness Intensive Therapy (Get FIT) to Promote Healthy Living in Older Adults", will test 2 behavioral interventions in community-dwelling older adults (age ≥ 60 years) at intermediate and high risk of cardiovascular disease.

1. Get FIT: use of a Fitbit activity tracker, smartphone application to track daily food intake, one 45 minute counseling session to create personal goals and provide patient education by a health coach; vs.
2. Get FIT+: use of a Fitbit activity tracker, smartphone application to track daily food intake, one 45 minute counseling session to create personal goals and provide patient education by a health coach, and personalized push-only text messages from the health coach based on participant's progress as monitored electronically in the application.

Each intervention lasts 3 months, with outcomes measured at baseline, 3 months, and 6 months.

Eligibility criteria: Inclusion Criteria:

* aged 60 or greater
* at intermediate (10-20%) or high risk (\>20%) of developing cardiovascular disease (as measured by Framingham Risk Assessment Tool)
* poor eating behaviors (as measured by Block Fruit/Vegetable/Fiber Screener)
* reduced physical activity (as measured by Block Adult Physical Activity Screener)

Exclusion Criteria:

* cognitive impairment (as measured by Mini-Cog) that impairs ability to understand consent process, surveys, or use of mobile health devices
* chronic drug use
* end stage renal, liver, or pulmonary disease
* current active cancer (i.e., undergoing active treatment for cancer)
* gastrointestinal disease which requires a special diet (e.g. Crohn's, celiac, etc).

Primary outcomes:
measure: Change from Baseline adherence to recommended self-care behaviors at 3 months and 6 months
timeFrame: baseline, 3 months, 6 months
measure: Change from Baseline diet patterns at 3 months and 6 months
timeFrame: baseline, 3 months, 6 months
measure: Change from baseline physical activity levels at 3 months and 6 months
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: change from baseline in HgA1c
timeFrame: baseline, 3 months, 6 months
measure: Change from baseline in Anxiety and Depression symptoms
timeFrame: baseline, 3 months, 6 months
measure: Change from baseline in patient activation
timeFrame: baseline, 3 months, 6 months
measure: Change from Baseline height in centimeters
timeFrame: baseline, 3 months, 6 months
measure: Change from baseline weight in kilograms
timeFrame: baseline, 3 months, 6 months
measure: Change from baseline body composition-area
timeFrame: baseline, 6 months
measure: Change from baseline body composition-Bone Mineral Content (BMC)
timeFrame: baseline, 6 months
measure: Change from baseline body composition-Bone Mineral Density (BMD)
timeFrame: baseline, 6 months
measure: Change from baseline body composition-Fat mass
timeFrame: baseline, 6 months
measure: Change from baseline body composition-Lean mass
timeFrame: baseline, 6 months
measure: Change from baseline body composition-Total Mass
timeFrame: baseline, 6 months
measure: Change from baseline body composition-% fat
timeFrame: baseline, 6 months
measure: Change from baseline in blood pressure
timeFrame: baseline, 3 months, 6 months
measure: Change from baseline in High-Density Lipoproteins (HDL)
timeFrame: baseline, 3 months, 6 months
measure: Change from baseline in Low-Density Lipoproteins (LDL)
timeFrame: baseline, 3 months, 6 months
measure: Change from baseline in Triglycerides
timeFrame: baseline, 3 months, 6 months
measure: Change from baseline in total cholesterol score
timeFrame: baseline, 3 months, 6 months
measure: change from baseline in quality of life
timeFrame: baseline, 3 months, 6 months
measure: change from baseline in patterns of use of clinic attendance
timeFrame: baseline, 3 months, 6 months
measure: change from baseline in patterns of use of mHealth
timeFrame: baseline, 3 months, 6 months
measure: change from baseline in patterns of use of Retention
timeFrame: baseline, 3 months, 6 months
measure: cost effectiveness
timeFrame: 6 months
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: University of California, Irvine Federally Qualified Health Clinic
state: California
city: Irvine
country: United States
facility: The Regents of the University of California, Irvine - Institute for Clinical & Translational Science (ICTS)
state: California
city: Irvine
country: United States
facility: University of California, Irvine Medical Clinic (Gottschalk)
state: California
city: Orange
country: United States
facility: The University of California, Irvine Medical Center
state: California
city: Santa Ana
country: United States
facility: University of California, Irvine Federally Qualified Health Clinic
state: California
Study officials:
affiliation: University of California, Irvine
name: Lorraine Evangelista, PhD
role: PRINCIPAL_INVESTIGATOR
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