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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG053162 | U.S. NIH Grant/Contract | View source |
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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.
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.
Each intervention lasts 3 months, with outcomes measured at baseline, 3 months, and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Get FIT | Active Comparator | The Get FIT intervention |
|
| Get FIT+ | Experimental | The Get FIT+ intervention, which includes push-only personalized text messages from a health coach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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; and one 45 minute behavioral counseling session to set personal goals and provide education by a health coach. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in HgA1c | HgA1c as obtained by venous puncture and blood analysis | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorraine Evangelista, PhD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine Federally Qualified Health Clinic | Anaheim | California | 92801 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22571733 | Background | Demiris G, Thompson H, Boquet J, Le T, Chaudhuri S, Chung J. Older adults' acceptance of a community-based telehealth wellness system. Inform Health Soc Care. 2013 Jan;38(1):27-36. doi: 10.3109/17538157.2011.647938. Epub 2012 May 9. | |
| 19737412 | Background | Schneider KM, O'Donnell BE, Dean D. Prevalence of multiple chronic conditions in the United States' Medicare population. Health Qual Life Outcomes. 2009 Sep 8;7:82. doi: 10.1186/1477-7525-7-82. |
| Label | URL |
|---|---|
| National Center for Chronic Disease Prevention and Health Promotion | View source |
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Participants will be randomized to one of two groups for the study duration (3 months):
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|
| 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. |
|
| baseline, 3 months, 6 months |
| Change from baseline in patient activation | Patient activation as measured by the Patient Activation Measure | baseline, 3 months, 6 months |
| Change from Baseline height in centimeters | height in centimeters as measured by stadiometer | baseline, 3 months, 6 months |
| Change from baseline weight in kilograms | weight in kilograms as measured by professional beam scale | baseline, 3 months, 6 months |
| Change from baseline body composition-area | body composition-area (cm2) as measured by dual-energy x-ray absorptiometry (DEXA) | 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) | 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) | baseline, 6 months |
| Change from baseline body composition-Fat mass | body composition - fat mass (g) as measured by dual-energy x-ray absorptiometry (DEXA) | baseline, 6 months |
| Change from baseline body composition-Lean mass | body composition - lean mass (g) as measured by dual-energy x-ray absorptiometry (DEXA) | baseline, 6 months |
| Change from baseline body composition-Total Mass | body composition - total mass (g) as measured by dual-energy x-ray absorptiometry (DEXA) | baseline, 6 months |
| Change from baseline body composition-% fat | body composition - % fat as measured by dual-energy x-ray absorptiometry (DEXA) | baseline, 6 months |
| Change from baseline in blood pressure | blood pressure as measured by calibrated aneroid sphygmomanometer | baseline, 3 months, 6 months |
| Change from baseline in High-Density Lipoproteins (HDL) | HDL as obtained by venous puncture and blood analysis | baseline, 3 months, 6 months |
| Change from baseline in Low-Density Lipoproteins (LDL) | LDL as obtained by venous puncture and blood analysis | baseline, 3 months, 6 months |
| Change from baseline in Triglycerides | Triglycerides as obtained by venous puncture and blood analysis | 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) | 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 | baseline, 3 months, 6 months |
| change from baseline in patterns of use of clinic attendance | patient patterns of use as measured by clinic attendance | baseline, 3 months, 6 months |
| change from baseline in patterns of use of mHealth | patient patterns of use as measured by use of mHealth | 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) | 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 | 6 months |
| The Regents of the University of California, Irvine - Institute for Clinical & Translational Science (ICTS) |
| Irvine |
| California |
| 92697-3959 |
| United States |
| University of California, Irvine Medical Clinic (Gottschalk) | Irvine | California | 92697 | United States |
| The University of California, Irvine Medical Center | Orange | California | 92697-3298 | United States |
| University of California, Irvine Federally Qualified Health Clinic | Santa Ana | California | 92701 | United States |
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| My Fitness Pal | View source |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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