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

April 26, 2017 updated by: Christine Pellegrini, Northwestern University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of NEAT!
Time Frame: 1 month
How many participants would continue to use or use NEAT! in the future
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to NEAT!
Time Frame: 1 Month
NEAT usage (days/month)
1 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
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
Baseline and 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Christine Pellegrini, Ph.D., Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

December 13, 2012

First Submitted That Met QC Criteria

December 18, 2012

First Posted (Estimate)

December 21, 2012

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCDTR01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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