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Sedentary behavior is associated with an increased risk of mortality and many health conditions including type 2 diabetes, obesity, cardiovascular disease, and metabolic syndrome, independent of the time spent in moderate-to-vigorous intensity physical activity (MVPA). Furthermore, independent of total sedentary time and MVPA, Healy et al. observed that individuals who had more breaks in sedentary time had lower 2-h plasma glucose. Recent experimental findings also suggests that breaking up prolonged bouts of sedentary behavior (≥ 20 minutes) with either light or moderate intensity activity for 2 minutes reduces postprandial glucose and insulin responses.10 Replacing sedentary time with light-intensity activity or nonexercise activity thermogenesis (NEAT) may help to reduce the health consequences of sedentary behavior. The purpose of this study is to develop a smartphone application (NEAT!) to encourage sedentary adults with diabetes to increase breaks in prolonged bouts of sedentary behavior objectively measured by an accelerometer. NEAT! will be refined by modifying technology created for the ENGAGED trial (RC1DK087126) and will work in conjunction with a Bluetooth enabled accelerometer that can detect bouts of sedentary behavior. When a sedentary bout (≥ 20 minutes) is detected, the smartphone application will trigger a reminder prompt to the user encouraging him/her to participate in NEAT for at least 2 minutes. Following the development, testing, and refining of the application, a sample of 10 sedentary adults with type 2 diabetes will be recruited to participate in a one month trial to examine the feasibility and acceptability of NEAT!. To our knowledge, this is the first study to design and examine the acceptability of a smartphone application that will target interrupting sedentary behavior with NEAT using objectively measured sedentary time in a diabetic population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEAT! | Experimental | Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEAT! | Behavioral | Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of NEAT! | How many participants would continue to use or use NEAT! in the future | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to NEAT! | NEAT usage (days/month) | 1 Month |
| Breaks in Sedentary Behavior | Changes in the number of breaks in sedentary behavior will be assessed via accelerometry between baseline and 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Pellegrini, Ph.D. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
Participants were only excluded if they did not meet the eligibility criteria or were no longer interested in participating.
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| ID | Title | Description |
|---|---|---|
| FG000 | NEAT! | Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | NEAT! | Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability of NEAT! | How many participants would continue to use or use NEAT! in the future | Posted | Count of Participants | Participants | 1 month |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NEAT! | Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Pellegrini, PhD | Northwestern University | 312-503-1395 | c-pellegrini@northwestern.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Baseline and 1 month |
| Changes in Total Sedentary Time | Changes in total sedentary behavior will be assessed via accelerometry between baseline and 1 month | Baseline and 1 month |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Secondary | Adherence to NEAT! | NEAT usage (days/month) | Posted | Mean | Standard Deviation | days | 1 Month |
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| Secondary | Breaks in Sedentary Behavior | Changes in the number of breaks in sedentary behavior will be assessed via accelerometry between baseline and 1 month | Posted | Mean | Standard Deviation | breaks/day | Baseline and 1 month |
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| Secondary | Changes in Total Sedentary Time | Changes in total sedentary behavior will be assessed via accelerometry between baseline and 1 month | One individual outlier showed opposite changes as compared with the other participants and was 2.1 standard deviations above the mean for change in percent of day spent in sedentary behavior; thus this individual was excluded from this analysis. | Posted | Mean | Standard Deviation | percentage of day spent sedentary | Baseline and 1 month |
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| 9 |
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| 9 |
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