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| Name | Class |
|---|---|
| JR Albert Foundation | UNKNOWN |
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The goal of the study is to determine if a Fitbit, a kind of accelerometer, provides feedback to subjects combined with an activity counseling program will result in an increase in physical activity of at least 20%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accelerometer feedback and lifestyle counseling | Experimental | The accelerometer, Fitbit, will be worn continuously. Fitbit can provide feedback to subjects about their physical activity. Subjects will wear the Fitbit for two weeks (without feedback) to obtain baseline activity data. The experimental group will then be instructed on use of the fitbit. Subjects will meet with the exercise counselor who will use accelerometer data to provide feedback and counseling to help the user increase their activity by at least 20% each day. In subjects who achieve an increase of 20%, the counseling will focus either on maintaining activity levels or increasing activity further depending on the desire of the subject. Counseling will be provided once weekly by phone and in person at least once a month. Following the 26th week the experimental subjects will continue to wear the Fitbit and receive feedback about their activity levels for an additional 24 weeks, but they will no longer receive counseling. |
|
| Accelerometer without Feedback | Experimental | The accelerometer, Fitbit, will be worn continuously. Subjects will wear the Fitbit for two weeks (without feedback) to obtain baseline activity data. The control group will continue to wear the fitbit for the next 24 weeks without any feedback or activity counseling. Following the 26th week of the study, the subjects in the control group will complete the same program given to the experimental group in weeks 2 through 26. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerometer feedback and lifestyle counseling | Other | Subjects will meet with the exercise counselor who will use accelerometer data to provide feedback and counseling to help the user increase their activity by at least 20% each day. In subjects who achieve an increase of 20%, the counseling will focus either on maintaining activity levels or increasing activity further depending on the desire of the subject. Counseling will be provided once weekly by phone and in person at least once a month. Following the 26th week the experimental subjects will continue to wear the Fitbit and receive feedback about their activity levels for an additional 24 weeks, but they will no longer receive counseling. The control group will receive no counseling for the first 26 weeks of the study and will then crossover to get accelerometry feedback and counseling for the last 24 weeks of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Activity units as determined by Accelerometry | 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight in kilograms | 6 and 12 months | |
| Body fat by bone density scan (DEXA) | 6 and 12 months | |
| Waist to hip ratio |
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Inclusion criteria
Volunteers from the public including subjects in the independent living section of Assisted Living Facilities between the ages of 65 and 85.
Those over 85 may participate with their personal physician's consent.
BMI 25-40 kg/m2 OR a waist circumference 88 cm or greater in women or 102 cm or greater in men
Sedentary (no more than 30 minutes of vigorous or 90 minutes of moderate activity per week)
Complete a Timed Get Up and Go test in <= 20 seconds
If walking is done with an assistive device, the subject must have no history of falling with the use of said device)
Subjects will complete the Physical Activity Readiness Questionnaire - Revised (PARQ-R) which is as follows:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Warren Thompson, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24485546 | Derived | Thompson WG, Kuhle CL, Koepp GA, McCrady-Spitzer SK, Levine JA. "Go4Life" exercise counseling, accelerometer feedback, and activity levels in older people. Arch Gerontol Geriatr. 2014 May-Jun;58(3):314-9. doi: 10.1016/j.archger.2014.01.004. Epub 2014 Jan 15. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| Accelerometer without Feedback | Other | The accelerometer, Fitbit, will be worn continuously. Fitbit can provide feedback to subjects about their physical activity. Subjects will wear the Fitbit for two weeks (without feedback) to obtain baseline activity data. The experimental group will then be instructed on use of the fitbit. This group will receive feedback from the accelerometer for the remainder of the study. The control group will wear the Fitbit but receive no feedback for the first 26 weeks of the study. For the last 24 weeks they will crossover and receive feedback from the Fitbit accelerometer. |
|
| 6 and 12 months |
| Fasting glucose | 6 and 12 months |
| Hemoglobin A1c | 6 and 12 months |
| Fasting insulin | 6 and 12 months |
| Fasting lipid profile | 6 and 12 months |
| high sensitivity c-reactive protein | 6 and 12 months |
| Body Mass Index | 6 and 12 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |