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
  Purpose

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 Intervention Phase
Diabetes Mellitus
Behavioral: NEAT!
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: NEAT! Technology to Increase Breaks in Sedentary Behavior in Adults With Diabetes

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 9
Study Start Date: February 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NEAT!
Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.
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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754467

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Christine Pellegrini, Ph.D. Northwestern University
  More Information

No publications provided

Responsible Party: Christine Pellegrini, Research Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01754467     History of Changes
Other Study ID Numbers: CCDTR01
Study First Received: December 13, 2012
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 23, 2014