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

November 15, 2022 updated by: Lorraine Evangelista, University of California, Irvine

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • University of California, Irvine Federally Qualified Health Clinic
      • Irvine, California, United States, 92697-3959
        • The Regents of the University of California, Irvine - Institute for Clinical & Translational Science (ICTS)
      • Irvine, California, United States, 92697
        • University of California, Irvine Medical Clinic (Gottschalk)
      • Orange, California, United States, 92697-3298
        • The University of California, Irvine Medical Center
      • Santa Ana, California, United States, 92701
        • University of California, Irvine Federally Qualified Health Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 3 months, 6 months
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©)
baseline, 3 months, 6 months
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©)
baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in HgA1c
Time Frame: baseline, 3 months, 6 months
HgA1c as obtained by venous puncture and blood analysis
baseline, 3 months, 6 months
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).
baseline, 3 months, 6 months
Change from baseline in patient activation
Time Frame: baseline, 3 months, 6 months
Patient activation as measured by the Patient Activation Measure
baseline, 3 months, 6 months
Change from Baseline height in centimeters
Time Frame: baseline, 3 months, 6 months
height in centimeters as measured by stadiometer
baseline, 3 months, 6 months
Change from baseline weight in kilograms
Time Frame: baseline, 3 months, 6 months
weight in kilograms as measured by professional beam scale
baseline, 3 months, 6 months
Change from baseline body composition-area
Time Frame: baseline, 6 months
body composition-area (cm2) as measured by dual-energy x-ray absorptiometry (DEXA)
baseline, 6 months
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)
baseline, 6 months
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)
baseline, 6 months
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)
baseline, 6 months
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)
baseline, 6 months
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)
baseline, 6 months
Change from baseline body composition-% fat
Time Frame: baseline, 6 months
body composition - % fat as measured by dual-energy x-ray absorptiometry (DEXA)
baseline, 6 months
Change from baseline in blood pressure
Time Frame: baseline, 3 months, 6 months
blood pressure as measured by calibrated aneroid sphygmomanometer
baseline, 3 months, 6 months
Change from baseline in High-Density Lipoproteins (HDL)
Time Frame: baseline, 3 months, 6 months
HDL as obtained by venous puncture and blood analysis
baseline, 3 months, 6 months
Change from baseline in Low-Density Lipoproteins (LDL)
Time Frame: baseline, 3 months, 6 months
LDL as obtained by venous puncture and blood analysis
baseline, 3 months, 6 months
Change from baseline in Triglycerides
Time Frame: baseline, 3 months, 6 months
Triglycerides as obtained by venous puncture and blood analysis
baseline, 3 months, 6 months
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)
baseline, 3 months, 6 months
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
baseline, 3 months, 6 months
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
baseline, 3 months, 6 months
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
baseline, 3 months, 6 months
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)
baseline, 3 months, 6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2019

Primary Completion (Actual)

March 12, 2022

Study Completion (Actual)

March 12, 2022

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

October 23, 2018

First Posted (Actual)

October 25, 2018

Study Record Updates

Last Update Posted (Actual)

November 18, 2022

Last Update Submitted That Met QC Criteria

November 15, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AG053162; HS#2016-2713
  • R21AG053162 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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