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OpenTrials
Completed

NCT Number: NCT03720327

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

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.

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Key information

Conditions

Cardiovascular Diseases Cardiovascular Risk Factor

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine Federally Qualified Health Clinic, Anaheim, California, United States

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About this study

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.

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Get FIT

Behavioral

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.

Get FIT+

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Fitness Intensive Therapy (Get FIT) to Promote Healthy Living in Older Adults

Acronym: GET FIT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2018
Registry last updated
Nov 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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