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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: NEAT! Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: NEAT! Technology to Increase Breaks in Sedentary Behavior in Adults With Diabetes
Study Start Date : February 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NEAT!
Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Acceptability of NEAT! [ Time Frame: 1 month ]
    How many participants would continue to use or use NEAT! in the future


Secondary Outcome Measures :
  1. Adherence to NEAT! [ Time Frame: 1 Month ]
    NEAT usage (days/month)

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754467


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Christine Pellegrini, Ph.D. Northwestern University
More Information
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Responsible Party: Christine Pellegrini, Research Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01754467    
Other Study ID Numbers: CCDTR01
First Posted: December 21, 2012    Key Record Dates
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases