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The investigators will recruit DoD beneficiaries, aged 18 years or older and diagnosed as being Type II diabetic. Patients will be randomized into one of two groups. Group 1 will use a fitness tracker but will not be able to see other participants data and group 2 will use a fitness tracker and will be able to see other members daily and weekly results. Outcome measures will be assessed at baseline, 3 months and 6 months to include hemoglobin A1c, weight, body mass index, blood pressure, and number of hours and days fitness tracker is used. The goal is to see if the group randomized into an online community will have improved activity and outcome measurements compared with those who use the pedometer alone.
Male and female DoD beneficiaries ages 18 years or older who have been diagnosed with Type II diabetes, will be recruited at the Mike O'Callaghan Federal Medical Center (MOFMC).
Screening Visit:
Obtain signed Informed Consent Document and HIPAA Authorization (research-driven).
Record: Date of birth, phone number, age, gender, race, ethnicity, social security number, current email address, height (in inches), weight (in pounds), blood pressure, medications list including any over-the-counter and prescription weight loss medication (name, strength, dose) or supplements.
Subjects will have the following standard of care blood test drawn which include:
Visit 1 (Day 1 within 1 week of Screening Visit):
Record: Weight (in pounds), blood pressure, and any changes to their medications list.
Subjects will complete the RAND 36 Item Health Survey.
Subjects will complete the Intake Questionnaire.
Subjects will be assigned their Fitness Tracker username and their username and password will be recorded by the Research Coordinator.
Subjects will be given User Instructions based off of their randomization group.
Subjects will be instructed to follow all research procedures and that failure to do so may result in the removal from the study and the return of the Fitness Tracker.
Subjects will be randomized by the research coordinator using a random-number generator into one of two groups (research-driven):
Group 1: will use a fitness tracker but will not be able to see other participant's data.
Group 2: will use a fitness tracker and will be able to see other member's daily and weekly results.
Subjects will be provided a fitness tracker and instructed on how to use it.
Visit 2 (Month 3/90 days post Visit 1):
Record: Weight (in pounds), blood pressure and any changes to their medications list.
Subjects will complete the RAND 36 Item Health Survey.
Subjects will complete the Follow up Questionnaire.
Obtain information from their fitness tracker.
Subjects will have the following standard of care blood test drawn which include:
Final Visit 3 (Month 6/90 days post Visit 2):
Record: Weight (in pounds), blood pressure and any changes to their medications list.
Subjects will complete the RAND 36 Item Health Survey and be asked some additional questions.
Subjects will complete the Follow up Questionnaire.
Obtain information from their fitness tracker.
Subjects will have the following standard of care blood test drawn which include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fitness Tracker | Experimental | will use a fitness tracker but will not be able to see other participant's data |
|
| Fitness Tracker with Group Participation | Experimental | will use a fitness tracker and will be able to see other member's daily and weekly results |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral: Fitness Tracker | Behavioral | will use a fitness tracker but will not be able to see other participant's data |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in hemoglobin a1c | 6 months |
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YOU MUST BE ABLE TO GET CARE AT NELLIS AFB (A MILITARY INSTALLATION) IN ORDER TO PARTICIPATE IN THIS STUDY.
Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| David Carlsen, MD | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mike O'Callaghan Federal Medical Center | Nellis Air Force Base | Nevada | 89191 | United States |
we do not plan on sharing data
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000072936 | Fitness Trackers |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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| Fitness Tracker | Behavioral | will use a fitness tracker and will be able to see other member's daily and weekly results |
|
| D004700 | Endocrine System Diseases |