NEAT! Technology to Increase Breaks in Sedentary Behavior in Adults With Diabetes
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ClinicalTrials.gov Identifier: NCT01754467 |
Recruitment Status :
Completed
First Posted : December 21, 2012
Results First Posted : April 28, 2017
Last Update Posted : April 28, 2017
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Sponsor:
Northwestern University
Information provided by (Responsible Party):
Christine Pellegrini, Northwestern University
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Tracking Information | ||||
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First Submitted Date ICMJE | December 13, 2012 | |||
First Posted Date ICMJE | December 21, 2012 | |||
Results First Submitted Date ICMJE | January 25, 2017 | |||
Results First Posted Date ICMJE | April 28, 2017 | |||
Last Update Posted Date | April 28, 2017 | |||
Study Start Date ICMJE | February 2013 | |||
Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Acceptability of NEAT! [ Time Frame: 1 month ] How many participants would continue to use or use NEAT! in the future
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Original Primary Outcome Measures ICMJE |
Evaluation of NEAT! [ Time Frame: 1 month ] A qualitative interview and questionnaire completed at 1 month will examine the acceptability of using NEAT!. The interview and questionnaires will address current perception, liking, barriers, and future use of the application.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | NEAT! Technology to Increase Breaks in Sedentary Behavior in Adults With Diabetes | |||
Official Title ICMJE | NEAT! Technology to Increase Breaks in Sedentary Behavior in Adults With Diabetes | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Diabetes Mellitus | |||
Intervention ICMJE | Behavioral: 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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Study Arms ICMJE | Experimental: NEAT!
Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.
Intervention: Behavioral: NEAT!
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
9 | |||
Original Estimated Enrollment ICMJE |
15 | |||
Actual Study Completion Date ICMJE | October 2013 | |||
Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01754467 | |||
Other Study ID Numbers ICMJE | CCDTR01 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Christine Pellegrini, Northwestern University | |||
Study Sponsor ICMJE | Northwestern University | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Northwestern University | |||
Verification Date | April 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |