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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
Sponsor:
Information provided by (Responsible Party):
Christine Pellegrini, Northwestern University

Tracking Information
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
 (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
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 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
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  ICMJE 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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
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
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