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

Cardiovascular Diseases Clinical Trial

— GET FIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03720327
• Other study ID #: R21AG053162; HS#2016-2713
• Secondary ID: R21AG053162
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: March 12, 2022

Study information

• Verified date: November 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 12, 2022
• Est. primary completion date: March 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, Irvine Federally Qualified Health Clinic	Anaheim	California
United States	The Regents of the University of California, Irvine - Institute for Clinical & Translational Science (ICTS)	Irvine	California
United States	University of California, Irvine Medical Clinic (Gottschalk)	Irvine	California
United States	The University of California, Irvine Medical Center	Orange	California
United States	University of California, Irvine Federally Qualified Health Clinic	Santa Ana	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

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* Note: There are 54 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline adherence to recommended self-care behaviors at 3 months and 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
Primary	Change from Baseline diet patterns at 3 months and 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
Primary	Change from baseline physical activity levels at 3 months and 6 months	data from Fitbit activity tracker as recorded in smartphone application (My Fitness Pal©)	baseline, 3 months, 6 months
Secondary	change from baseline in HgA1c	HgA1c as obtained by venous puncture and blood analysis	baseline, 3 months, 6 months
Secondary	Change from baseline in Anxiety and Depression symptoms	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
Secondary	Change from baseline in patient activation	Patient activation as measured by the Patient Activation Measure	baseline, 3 months, 6 months
Secondary	Change from Baseline height in centimeters	height in centimeters as measured by stadiometer	baseline, 3 months, 6 months
Secondary	Change from baseline weight in kilograms	weight in kilograms as measured by professional beam scale	baseline, 3 months, 6 months
Secondary	Change from baseline body composition-area	body composition-area (cm2) as measured by dual-energy x-ray absorptiometry (DEXA)	baseline, 6 months
Secondary	Change from baseline body composition-Bone Mineral Content (BMC)	body composition - BMC (g) as measured by dual-energy x-ray absorptiometry (DEXA)	baseline, 6 months
Secondary	Change from baseline body composition-Bone Mineral Density (BMD)	body composition - BMD (g/cm2) as measured by dual-energy x-ray absorptiometry (DEXA)	baseline, 6 months
Secondary	Change from baseline body composition-Fat mass	body composition - fat mass (g) as measured by dual-energy x-ray absorptiometry (DEXA)	baseline, 6 months
Secondary	Change from baseline body composition-Lean mass	body composition - lean mass (g) as measured by dual-energy x-ray absorptiometry (DEXA)	baseline, 6 months
Secondary	Change from baseline body composition-Total Mass	body composition - total mass (g) as measured by dual-energy x-ray absorptiometry (DEXA)	baseline, 6 months
Secondary	Change from baseline body composition-% fat	body composition - % fat as measured by dual-energy x-ray absorptiometry (DEXA)	baseline, 6 months
Secondary	Change from baseline in blood pressure	blood pressure as measured by calibrated aneroid sphygmomanometer	baseline, 3 months, 6 months
Secondary	Change from baseline in High-Density Lipoproteins (HDL)	HDL as obtained by venous puncture and blood analysis	baseline, 3 months, 6 months
Secondary	Change from baseline in Low-Density Lipoproteins (LDL)	LDL as obtained by venous puncture and blood analysis	baseline, 3 months, 6 months
Secondary	Change from baseline in Triglycerides	Triglycerides as obtained by venous puncture and blood analysis	baseline, 3 months, 6 months
Secondary	Change from baseline in total cholesterol score	total cholesterol score as obtained by venous puncture and blood analysis (HDL+LDL+0.2*triglycerides=total)	baseline, 3 months, 6 months
Secondary	change from baseline in quality of life	quality of life as measured by the Quality of Life Short Form version 20	baseline, 3 months, 6 months
Secondary	change from baseline in patterns of use of clinic attendance	patient patterns of use as measured by clinic attendance	baseline, 3 months, 6 months
Secondary	change from baseline in patterns of use of mHealth	patient patterns of use as measured by use of mHealth	baseline, 3 months, 6 months
Secondary	change from baseline in patterns of use of Retention	patient patterns of use and engagement as measured by Retention (drop out rate and time of drop out)	baseline, 3 months, 6 months
Secondary	cost effectiveness	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

External Links

•   Chronic Care Making the Case for On-Going care publication avail through Robert Wood Johnson Foundation
•   My Fitness Pal
•   National Center for Chronic Disease Prevention and Health Promotion