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

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01754467
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 8
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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!	N/A

Study Design

• Study Type: Interventional
• 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: Feb 1, 2013
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

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

Primary Outcome Measures

1. Acceptability of NEAT! [1 month]

   How many participants would continue to use or use NEAT! in the future

Secondary Outcome Measures

1. Adherence to NEAT! [1 Month]

   NEAT usage (days/month)

2. Breaks in Sedentary Behavior [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 [Baseline and 1 month]

   Changes in total sedentary behavior will be assessed via accelerometry between baseline and 1 month

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christine Pellegrini, Research Assistant Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT01754467
• Other Study ID Numbers: CCDTR01
• First Posted: Dec 21, 2012
• Last Update Posted: Apr 28, 2017
• Last Verified: Apr 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

Participant Flow

Pre-assignment Detail	Participants were only excluded if they did not meet the eligibility criteria or were no longer interested in participating.

Arm/Group Title	NEAT!
Arm/Group Description	Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. 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.
Period Title: Overall Study
STARTED	9
COMPLETED	8
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	NEAT!
Arm/Group Description	Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. 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.
Overall Participants	9
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	7 77.8%
>=65 years	2 22.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.1 (10.7)
Sex: Female, Male (Count of Participants)
Female	7 77.8%
Male	2 22.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	9 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	7 77.8%
White	2 22.2%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	9 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	37.4 (9.9)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NEAT!
Arm/Group Description	Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. 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.
Measure Participants	8
Count of Participants [Participants]	7 77.8%

2. Secondary Outcome

Title	Adherence to NEAT!
Description	NEAT usage (days/month)
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NEAT!
Arm/Group Description	Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. 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.
Measure Participants	8
Mean (Standard Deviation) [days]	21.9 (8.0)

3. Secondary Outcome

Title	Breaks in Sedentary Behavior
Description	Changes in the number of breaks in sedentary behavior will be assessed via accelerometry between baseline and 1 month
Time Frame	Baseline and 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NEAT!
Arm/Group Description	Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. 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.
Measure Participants	8
Mean (Standard Deviation) [breaks/day]	67.6 (15.1)

4. Secondary Outcome

Title	Changes in Total Sedentary Time
Description	Changes in total sedentary behavior will be assessed via accelerometry between baseline and 1 month
Time Frame	Baseline and 1 month

Outcome Measure Data

Analysis Population Description

One individual outlier showed opposite changes as compared with the other participants and was 2.1 standard deviations above the mean for change in percent of day spent in sedentary behavior; thus this individual was excluded from this analysis.

Arm/Group Title	NEAT!
Arm/Group Description	Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. 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.
Measure Participants	7
Mean (Standard Deviation) [percentage of day spent sedentary]	-8.1 (4.5)

Adverse Events

Arm/Group Title	NEAT!
Arm/Group Description	Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. 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.
All Cause Mortality
	NEAT!
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	NEAT!
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Other (Not Including Serious) Adverse Events
	NEAT!
	Affected / at Risk (%)	# Events
Total	0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.