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

Sponsor
University of California, Irvine (Other)
Overall Status
Recruiting
CT.gov ID
NCT03720327
Collaborator
(none)
50
Enrollment
5
Locations
2
Arms
38
Anticipated Duration (Months)
10
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Get FIT
  • Behavioral: Get FIT+
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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): control group (Get FIT); intervention group (Get FIT+).Participants will be randomized to one of two groups for the study duration (3 months):control group (Get FIT); 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 :
Jan 10, 2019
Anticipated Primary Completion Date :
Mar 12, 2022
Anticipated Study Completion Date :
Mar 12, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline adherence to recommended self-care behaviors at 3 months and 6 months [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 [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 [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 [baseline, 3 months, 6 months]

    HgA1c as obtained by venous puncture and blood analysis

  2. Change from baseline in Anxiety and Depression symptoms [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 [baseline, 3 months, 6 months]

    Patient activation as measured by the Patient Activation Measure

  4. Change from Baseline height in centimeters [baseline, 3 months, 6 months]

    height in centimeters as measured by stadiometer

  5. Change from baseline weight in kilograms [baseline, 3 months, 6 months]

    weight in kilograms as measured by professional beam scale

  6. Change from baseline body composition-area [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) [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) [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 [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 [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 [baseline, 6 months]

    body composition - total mass (g) as measured by dual-energy x-ray absorptiometry (DEXA)

  12. Change from baseline body composition-% fat [baseline, 6 months]

    body composition - % fat as measured by dual-energy x-ray absorptiometry (DEXA)

  13. Change from baseline in blood pressure [baseline, 3 months, 6 months]

    blood pressure as measured by calibrated aneroid sphygmomanometer

  14. Change from baseline in High-Density Lipoproteins (HDL) [baseline, 3 months, 6 months]

    HDL as obtained by venous puncture and blood analysis

  15. Change from baseline in Low-Density Lipoproteins (LDL) [baseline, 3 months, 6 months]

    LDL as obtained by venous puncture and blood analysis

  16. Change from baseline in Triglycerides [baseline, 3 months, 6 months]

    Triglycerides as obtained by venous puncture and blood analysis

  17. Change from baseline in total cholesterol score [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 [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 [baseline, 3 months, 6 months]

    patient patterns of use as measured by clinic attendance

  20. change from baseline in patterns of use of mHealth [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 [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 [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

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, Irvine Federally Qualified Health Clinic Anaheim California United States 92801
2 The Regents of the University of California, Irvine - Institute for Clinical & Translational Science (ICTS) Irvine California United States 92697-3959
3 University of California, Irvine Medical Clinic (Gottschalk) Irvine California United States 92697
4 The University of California, Irvine Medical Center Orange California United States 92697-3298
5 University of California, Irvine Federally Qualified Health Clinic Santa Ana California United States 92701

Sponsors and Collaborators

  • University of California, Irvine

Investigators

  • Principal Investigator: Lorraine Evangelista, PhD, University of California, Irvine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT03720327
Other Study ID Numbers:
  • R21AG053162; HS#2016-2713
  • R21AG053162
First Posted:
Oct 25, 2018
Last Update Posted:
Apr 21, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cardiovascular Diseases

Study Results

No Results Posted as of Apr 21, 2021