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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christine Pellegrini, Northwestern University
ClinicalTrials.gov Identifier:
NCT01754467
First received: December 13, 2012
Last updated: January 14, 2014
Last verified: January 2014

December 13, 2012
January 14, 2014
February 2013
October 2013   (final data collection date for primary outcome measure)
Evaluation of NEAT! [ Time Frame: 1 month ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01754467 on ClinicalTrials.gov Archive Site
  • Adherence to NEAT! [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
    Following NEAT! usage 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 ] [ Designated as safety issue: No ]
    Changes in the number of breaks in sedentary behavior will be assessed via accelerometry
  • Total sedentary time [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
    Changes in total sedentary behavior will be assessed via accelerometry
  • Adherence to NEAT! [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Changes in the number of breaks in sedentary behavior will be assessed via acceleterometry
  • Total sedentary time [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
    Changes in total sedentary behavior will be assessed via acceleterometry
Not Provided
Not Provided
 
NEAT! Technology to Increase Breaks in Sedentary Behavior in Adults With Diabetes
NEAT! Technology to Increase Breaks in Sedentary Behavior in Adults With Diabetes

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Diabetes Mellitus
Behavioral: NEAT!
A total of 10 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.
Experimental: NEAT!
Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.
Intervention: Behavioral: NEAT!
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01754467
CCDTR01
No
Christine Pellegrini, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Christine Pellegrini, Ph.D. Northwestern University
Northwestern University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP