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The Effects of a Mobile Health Intervention and Health Coach Text Messaging on Cardiovascular Risk of Older Adults (GET FIT)

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ClinicalTrials.gov Identifier: NCT03720327
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Cardiovascular Risk Factor Behavioral: Get FIT Behavioral: Get FIT+ Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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+).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Fitness Intensive Therapy (Get FIT) to Promote Healthy Living in Older Adults
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : May 31, 2020

Arm Intervention/treatment
Active Comparator: Get FIT
The Get FIT intervention
Behavioral: Get FIT
The Get FIT arm includes use of a free commercially available smartphone application to track daily food intake for 3 months; use of a Fitbit activity tracker for 3 months; and one 45 minute behavioral counseling session to set personal goals and provide education by a health coach.

Experimental: Get FIT+
The Get FIT+ intervention, which includes push-only personalized text messages from a health coach.
Behavioral: Get FIT+
The Get FIT+ arm includes use of a free commercially available smartphone application to track daily food intake for 3 months; use of a Fitbit activity tracker for 3 months; one 45 minute behavioral counseling session to set personal goals and provide education by a health coach; and personalized text messaging for 3 months by a health coach. The health coach will have access to these participants' daily food and activity data through the smartphone application, and will monitor progress and send push-only text messages to participants in this group based on the participant's goals and progress in the areas of physical activity, nutrition, and weight loss.




Primary Outcome Measures :
  1. Change from Baseline adherence to recommended self-care behaviors at 3 months and 6 months [ Time Frame: baseline, 3 months, 6 months ]
    The Medical Outcomes Study Specific Adherence Scale measures patient adherence to 8 recommended health behaviors (3 items on specific diet/nutrition, 1 item on smoking cessation, 1 item on alcoholic beverages, 1 item on taking prescribed medications, 1 item on regular exercise, 1 item on weight/fluid, 1 item on symptom management). Participants circle the answer that best corresponds to their behavior in the last 4 weeks ("None of the time; 1-A little of the time; 2-Some of the time; 3-A good bit of the time; 4-Most of the time; 5-All of the time"). Scoring is the average of the items for a total specific adherence score.

  2. Change from Baseline diet patterns at 3 months and 6 months [ Time Frame: baseline, 3 months, 6 months ]
    3-Day Food Record (ASA24); data from self-recorded diet as entered in smartphone application (My Fitness Pal©)

  3. Change from baseline physical activity levels at 3 months and 6 months [ Time Frame: baseline, 3 months, 6 months ]
    data from Fitbit activity tracker as recorded in smartphone application (My Fitness Pal©)


Secondary Outcome Measures :
  1. change from baseline in HgA1c [ Time Frame: baseline, 3 months, 6 months ]
    HgA1c as obtained by venous puncture and blood analysis

  2. Change from baseline in Anxiety and Depression symptoms [ Time Frame: baseline, 3 months, 6 months ]
    Anxiety and depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS). Subscale scores of Anxiety (range 0-21; lower scores representing "normal" scores) and Depression (range 0-21; lower scores representing "normal" scores).

  3. Change from baseline in patient activation [ Time Frame: baseline, 3 months, 6 months ]
    Patient activation as measured by the Patient Activation Measure

  4. Change from Baseline height in centimeters [ Time Frame: baseline, 3 months, 6 months ]
    height in centimeters as measured by stadiometer

  5. Change from baseline weight in kilograms [ Time Frame: baseline, 3 months, 6 months ]
    weight in kilograms as measured by professional beam scale

  6. Change from baseline body composition-area [ Time Frame: baseline, 6 months ]
    body composition-area (cm2) as measured by dual-energy x-ray absorptiometry (DEXA)

  7. Change from baseline body composition-Bone Mineral Content (BMC) [ Time Frame: baseline, 6 months ]
    body composition - BMC (g) as measured by dual-energy x-ray absorptiometry (DEXA)

  8. Change from baseline body composition-Bone Mineral Density (BMD) [ Time Frame: baseline, 6 months ]
    body composition - BMD (g/cm2) as measured by dual-energy x-ray absorptiometry (DEXA)

  9. Change from baseline body composition-Fat mass [ Time Frame: baseline, 6 months ]
    body composition - fat mass (g) as measured by dual-energy x-ray absorptiometry (DEXA)

  10. Change from baseline body composition-Lean mass [ Time Frame: baseline, 6 months ]
    body composition - lean mass (g) as measured by dual-energy x-ray absorptiometry (DEXA)

  11. Change from baseline body composition-Total Mass [ Time Frame: baseline, 6 months ]
    body composition - total mass (g) as measured by dual-energy x-ray absorptiometry (DEXA)

  12. Change from baseline body composition-% fat [ Time Frame: baseline, 6 months ]
    body composition - % fat as measured by dual-energy x-ray absorptiometry (DEXA)

  13. Change from baseline in blood pressure [ Time Frame: baseline, 3 months, 6 months ]
    blood pressure as measured by calibrated aneroid sphygmomanometer

  14. Change from baseline in High-Density Lipoproteins (HDL) [ Time Frame: baseline, 3 months, 6 months ]
    HDL as obtained by venous puncture and blood analysis

  15. Change from baseline in Low-Density Lipoproteins (LDL) [ Time Frame: baseline, 3 months, 6 months ]
    LDL as obtained by venous puncture and blood analysis

  16. Change from baseline in Triglycerides [ Time Frame: baseline, 3 months, 6 months ]
    Triglycerides as obtained by venous puncture and blood analysis

  17. Change from baseline in total cholesterol score [ Time Frame: baseline, 3 months, 6 months ]
    total cholesterol score as obtained by venous puncture and blood analysis (HDL+LDL+0.2*triglycerides=total)

  18. change from baseline in quality of life [ Time Frame: baseline, 3 months, 6 months ]
    quality of life as measured by the Quality of Life Short Form version 20

  19. change from baseline in patterns of use of clinic attendance [ Time Frame: baseline, 3 months, 6 months ]
    patient patterns of use as measured by clinic attendance

  20. change from baseline in patterns of use of mHealth [ Time Frame: baseline, 3 months, 6 months ]
    patient patterns of use as measured by use of mHealth

  21. change from baseline in patterns of use of Retention [ Time Frame: baseline, 3 months, 6 months ]
    patient patterns of use and engagement as measured by Retention (drop out rate and time of drop out)

  22. cost effectiveness [ Time Frame: 6 months ]
    Cost effectiveness of the intervention as calculated by the sum of costs of training, staff salary, frequency/duration of counseling sessions, follow up visits, real time feedback



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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): NCT03720327


Contacts
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Contact: Lorraine Evangelista, PhD 661-993-8463 evangell@uci.edu
Contact: Laura Narvaez, BSN 949-824-8707 lmnarvae@uci.edu

Locations
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United States, California
University of California, Irvine Federally Qualified Health Clinic Recruiting
Anaheim, California, United States, 92801
Contact: Director    657-282-6356      
The Regents of the University of California, Irvine - Institute for Clinical & Translational Science (ICTS) Recruiting
Irvine, California, United States, 92697-3959
Contact: Director    949-824-3350    icts@uci.edu   
University of California, Irvine Medical Clinic (Gottschalk) Recruiting
Irvine, California, United States, 92697
Contact: Director    949-824-8600      
The University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92697-3298
Contact: Director    714-456-7890      
University of California, Irvine Federally Qualified Health Clinic Recruiting
Santa Ana, California, United States, 92701
Contact: Director    657-282-6355      
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Lorraine Evangelista, PhD University of California, Irvine

Additional Information:
Publications:
WRITING GROUP MEMBERS, Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. Erratum in: Circulation. 2010 Mar 30;121(12):e260. Stafford, Randall [corrected to Roger, Véronique L]. Circulation. 2011 Oct 18;124(16):e425.
Schakel SF. Maintaining a nutrient database in a changing marketplace: Keeping pace with changing food products-- A research perspective. Journal of Food Composition and Analysis 2001;14:315-322.

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Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT03720327     History of Changes
Other Study ID Numbers: R21AG053162; HS#2016-2713
R21AG053162 ( U.S. NIH Grant/Contract )
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
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
Additional relevant MeSH terms:
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Cardiovascular Diseases