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

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status

Completed

Conditions

Cardiovascular Diseases
Cardiovascular Risk Factor

Treatments

Behavioral: Get FIT+
Behavioral: Get FIT

Study type

Interventional

Funder types

Other

Identifiers

NCT03720327
R21AG053162 HS#2016-2713;
R21AG053162 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

54 participants in 2 patient groups

Get FIT
Active Comparator group
Description:
The Get FIT intervention
Treatment:
Behavioral: Get FIT
Get FIT+
Experimental group
Description:
The Get FIT+ intervention, which includes push-only personalized text messages from a health coach.
Treatment:
Behavioral: Get FIT+

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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