NEAT! Technology to Increase Breaks in Sedentary Behavior in Adults With Diabetes

Tracking Information
First Submitted Date ICMJE	December 13, 2012
First Posted Date ICMJE	December 21, 2012
Results First Submitted Date	January 25, 2017
Results First Posted Date	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; (submitted: April 26, 2017)	Acceptability of NEAT! [ Time Frame: 1 month ]; How many participants would continue to use or use NEAT! in the future
Original Primary Outcome Measures ICMJE; (submitted: December 18, 2012)	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.
Change History	Complete list of historical versions of study NCT01754467 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 26, 2017)	Adherence to NEAT! [ Time Frame: 1 Month ]NEAT usage (days/month); Breaks in Sedentary Behavior [ Time Frame: Baseline and 1 month ]Changes in the number of breaks in sedentary behavior will be assessed via accelerometry between baseline and 1 month; Changes in Total Sedentary Time [ Time Frame: Baseline and 1 month ]Changes in total sedentary behavior will be assessed via accelerometry between baseline and 1 month
Original Secondary Outcome Measures ICMJE; (submitted: December 18, 2012)	Adherence to NEAT! [ Time Frame: 1 Month ]Following NEAT! usuage data will be examined to assess adherence to NEAT!: 1)Technology usage (days/month, hours/day), 2) adherence to prompts (number of prompts adhered to/total number of prompts), and 3) ignore buttons usage (daily times used).; Breaks in Sedentary Behavior [ Time Frame: Baseline and 1 month ]Changes in the number of breaks in sedentary behavior will be assessed via acceleterometry; Total sedentary time [ Time Frame: Baseline and 1 month ]Changes in total sedentary behavior will be assessed via acceleterometry
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
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.
Study Arms	Experimental: NEAT!; Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.; Intervention: Behavioral: NEAT!
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 14, 2014)	9
Original Estimated Enrollment ICMJE; (submitted: December 18, 2012)	15
Actual Study Completion Date	October 2013
Actual Primary Completion Date	October 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 21-70 years of age; have physician diagnosed type 2 diabetes that is currently being treated by dietary modification, oral agents, or insulin; currently and plan on having an Android smartphone for the next 2 months; be willing to wear an accelerometer and use the NEAT! application; spend the majority of the day sitting. Exclusion Criteria: unable to ambulate without assistance
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years to 70 Years (Adult, Older Adult)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	Christine Pellegrini, Northwestern University
Study Sponsor ICMJE	Northwestern University
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Christine Pellegrini, Ph.D. Northwestern University
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