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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754467
• Other study ID #: CCDTR01
• Status: Completed
• Phase: N/A
• First received: December 13, 2012
• Last updated: April 26, 2017
• Start date: February 2013
• Est. completion date: October 2013

Study information

• Verified date: April 2017
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of NEAT!	How many participants would continue to use or use NEAT! in the future	1 month
Secondary	Adherence to NEAT!	NEAT usage (days/month)	1 Month
Secondary	Breaks in Sedentary Behavior	Changes in the number of breaks in sedentary behavior will be assessed via accelerometry between baseline and 1 month	Baseline and 1 month
Secondary	Changes in Total Sedentary Time	Changes in total sedentary behavior will be assessed via accelerometry between baseline and 1 month	Baseline and 1 month