The Effects of a Mobile Health Intervention and Health Coach Text Messaging on Cardiovascular Risk of Older Adults
- Conditions
- Cardiovascular DiseasesCardiovascular Risk Factor
- Registration Number
- NCT03720327
- Lead Sponsor
- University of California, Irvine
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from Baseline diet patterns at 3 months and 6 months baseline, 3 months, 6 months 3-Day Food Record (ASA24); data from self-recorded diet as entered in smartphone application (My Fitness Pal©)
Change from Baseline adherence to recommended self-care behaviors at 3 months and 6 months 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.
Change from baseline physical activity levels at 3 months and 6 months baseline, 3 months, 6 months data from Fitbit activity tracker as recorded in smartphone application (My Fitness Pal©)
- Secondary Outcome Measures
Name Time Method Change from Baseline height in centimeters baseline, 3 months, 6 months height in centimeters as measured by stadiometer
Change from baseline body composition-area baseline, 6 months body composition-area (cm2) as measured by dual-energy x-ray absorptiometry (DEXA)
Change from baseline in blood pressure baseline, 3 months, 6 months blood pressure as measured by calibrated aneroid sphygmomanometer
Change from baseline in patient activation baseline, 3 months, 6 months Patient activation as measured by the Patient Activation Measure
Change from baseline in Anxiety and Depression symptoms 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).
Change from baseline weight in kilograms baseline, 3 months, 6 months weight in kilograms as measured by professional beam scale
Change from baseline body composition-Bone Mineral Density (BMD) baseline, 6 months body composition - BMD (g/cm2) as measured by dual-energy x-ray absorptiometry (DEXA)
Change from baseline body composition-Bone Mineral Content (BMC) baseline, 6 months body composition - BMC (g) as measured by dual-energy x-ray absorptiometry (DEXA)
Change from baseline body composition-Fat mass baseline, 6 months body composition - fat mass (g) as measured by dual-energy x-ray absorptiometry (DEXA)
Change from baseline in High-Density Lipoproteins (HDL) baseline, 3 months, 6 months HDL as obtained by venous puncture and blood analysis
Change from baseline in total cholesterol score baseline, 3 months, 6 months total cholesterol score as obtained by venous puncture and blood analysis (HDL+LDL+0.2\*triglycerides=total)
change from baseline in patterns of use of clinic attendance baseline, 3 months, 6 months patient patterns of use as measured by clinic attendance
change from baseline in patterns of use of mHealth baseline, 3 months, 6 months patient patterns of use as measured by use of mHealth
change from baseline in HgA1c baseline, 3 months, 6 months HgA1c as obtained by venous puncture and blood analysis
Change from baseline body composition-Lean mass baseline, 6 months body composition - lean mass (g) as measured by dual-energy x-ray absorptiometry (DEXA)
Change from baseline in Low-Density Lipoproteins (LDL) baseline, 3 months, 6 months LDL as obtained by venous puncture and blood analysis
Change from baseline in Triglycerides baseline, 3 months, 6 months Triglycerides as obtained by venous puncture and blood analysis
change from baseline in quality of life baseline, 3 months, 6 months quality of life as measured by the Quality of Life Short Form version 20
Change from baseline body composition-% fat baseline, 6 months body composition - % fat as measured by dual-energy x-ray absorptiometry (DEXA)
change from baseline in patterns of use of Retention baseline, 3 months, 6 months patient patterns of use and engagement as measured by Retention (drop out rate and time of drop out)
Change from baseline body composition-Total Mass baseline, 6 months body composition - total mass (g) as measured by dual-energy x-ray absorptiometry (DEXA)
cost effectiveness 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
Trial Locations
- Locations (4)
University of California, Irvine Federally Qualified Health Clinic
🇺🇸Santa Ana, 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