Clinical trial NCT01754467: NEAT! Technology to Increase Breaks in Sedentary Behavior in Adults With Diabetes
Official title: NEAT! Technology to Increase Breaks in Sedentary Behavior in Adults With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-12-21
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Acceptability of NEAT!
timeFrame: 1 month
Secondary outcomes:
measure: Adherence to NEAT!
timeFrame: 1 Month
measure: Breaks in Sedentary Behavior
timeFrame: Baseline and 1 month
measure: Changes in Total Sedentary Time
timeFrame: Baseline and 1 month
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Christine Pellegrini, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: