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

N/ACompletedNCT03720327

University of California, Irvine54 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Interventions

Get FITBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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).

Locations (5)

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, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline, 3 months, 6 months

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©)

Time frame: baseline, 3 months, 6 months

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©)

Time frame: baseline, 3 months, 6 months

Secondary Outcomes

change from baseline in HgA1c

HgA1c as obtained by venous puncture and blood analysis

Time frame: baseline, 3 months, 6 months

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).

Time frame: baseline, 3 months, 6 months

Change from baseline in patient activation

Patient activation as measured by the Patient Activation Measure

Time frame: baseline, 3 months, 6 months

Change from Baseline height in centimeters

height in centimeters as measured by stadiometer

Time frame: baseline, 3 months, 6 months

Change from baseline weight in kilograms

weight in kilograms as measured by professional beam scale

Time frame: baseline, 3 months, 6 months

Change from baseline body composition-area

body composition-area (cm2) as measured by dual-energy x-ray absorptiometry (DEXA)

Time frame: baseline, 6 months

Change from baseline body composition-Bone Mineral Content (BMC)

body composition - BMC (g) as measured by dual-energy x-ray absorptiometry (DEXA)

Time frame: baseline, 6 months

Change from baseline body composition-Bone Mineral Density (BMD)

body composition - BMD (g/cm2) as measured by dual-energy x-ray absorptiometry (DEXA)

Time frame: baseline, 6 months

Change from baseline body composition-Fat mass

body composition - fat mass (g) as measured by dual-energy x-ray absorptiometry (DEXA)

Time frame: baseline, 6 months

Change from baseline body composition-Lean mass

body composition - lean mass (g) as measured by dual-energy x-ray absorptiometry (DEXA)

Time frame: baseline, 6 months

Change from baseline body composition-Total Mass

body composition - total mass (g) as measured by dual-energy x-ray absorptiometry (DEXA)

Time frame: baseline, 6 months

Change from baseline body composition-% fat

body composition - % fat as measured by dual-energy x-ray absorptiometry (DEXA)

Time frame: baseline, 6 months

Change from baseline in blood pressure

blood pressure as measured by calibrated aneroid sphygmomanometer

Time frame: baseline, 3 months, 6 months

Change from baseline in High-Density Lipoproteins (HDL)

HDL as obtained by venous puncture and blood analysis

Time frame: baseline, 3 months, 6 months

Change from baseline in Low-Density Lipoproteins (LDL)

LDL as obtained by venous puncture and blood analysis

Time frame: baseline, 3 months, 6 months

Change from baseline in Triglycerides

Triglycerides as obtained by venous puncture and blood analysis

Time frame: baseline, 3 months, 6 months

Change from baseline in total cholesterol score

total cholesterol score as obtained by venous puncture and blood analysis (HDL+LDL+0.2\*triglycerides=total)

Time frame: baseline, 3 months, 6 months

change from baseline in quality of life

quality of life as measured by the Quality of Life Short Form version 20

Time frame: baseline, 3 months, 6 months

change from baseline in patterns of use of clinic attendance

patient patterns of use as measured by clinic attendance

Time frame: baseline, 3 months, 6 months

change from baseline in patterns of use of mHealth

patient patterns of use as measured by use of mHealth

Time frame: baseline, 3 months, 6 months

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)

Time frame: baseline, 3 months, 6 months

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

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.