The Effects of a Mobile Health Intervention and Health Coach Text Messaging on Cardiovascular Risk of Older Adults
NCT ID: NCT03720327
Last Updated: 2022-11-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
54 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-01-10
Study Completion Date
2022-03-12
Brief Summary
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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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Detailed Description
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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.
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.
Conditions
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Cardiovascular Diseases
Cardiovascular Risk Factor
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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+).
1. control group (Get FIT);
2. intervention group (Get FIT+).
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Study Groups
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Get FIT
The Get FIT intervention
Group Type
ACTIVE_COMPARATOR
Get FIT
Intervention Type
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+
The Get FIT+ intervention, which includes push-only personalized text messages from a health coach.
Group Type
EXPERIMENTAL
Get FIT+
Intervention Type
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.
Interventions
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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.
Intervention Type
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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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)
* 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).
* 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).
Minimum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of California, Irvine
OTHER
Sponsor Role
lead
Responsible Party
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Lorraine Evangelista
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Lorraine Evangelista, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine
Locations
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University of California, Irvine Federally Qualified Health Clinic
Anaheim, California, United States
Site Status
The Regents of the University of California, Irvine - Institute for Clinical & Translational Science (ICTS)
Irvine, California, United States
Site Status
University of California, Irvine Medical Clinic (Gottschalk)
Irvine, California, United States
Site Status
The University of California, Irvine Medical Center
Orange, California, United States
Site Status
University of California, Irvine Federally Qualified Health Clinic
Santa Ana, California, United States
Site Status
Countries
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United States
References
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DERIVED
Candelaria D, Cacciata M, Serafica R, Reyes AT, Lee JA, Hildebrand JA, Sta Maria A, Stromberg A, Evangelista LS. Patient activation improves with a multi-component personalized mHealth intervention in older patients at risk of cardiovascular disease: a pilot randomized controlled trial. Eur J Cardiovasc Nurs. 2025 Mar 3;24(2):316-322. doi: 10.1093/eurjcn/zvae159.
Reference Type
DERIVED
Related Links
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https://www.myfitnesspal.com/
My Fitness Pal
Other Identifiers
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R21AG053162; HS#2016-2713
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
NA
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PHASE1/PHASE2
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COMPLETED
NA
Dissemination of the Look Ahead Weight Management Treatment in the Military
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COMPLETED
NA
"F!reF!ghterF!t": Lifestyle Coaching Interventions for Obese Firefighters (FireFit)
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RECRUITING
NA