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

• ClinicalTrials.gov Identifier: NCT01754467
• Recruitment Status: Completed
• First Posted: December 21, 2012
• Results First Posted: April 28, 2017
• Last Update Posted: April 28, 2017
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Christine Pellegrini, Northwestern University

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Diabetes Mellitus
• Intervention: Behavioral: NEAT!
• Enrollment: 9

Participant Flow

Recruitment Details
Pre-assignment Details	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
Reason Not Completed
Lost to Follow-up	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 Number of Baseline Participants		9
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	7 77.8%
	>=65 years	2 22.2%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	9 participants
		53.1 (10.7)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants
	Female	7 77.8%
	Male	2 22.2%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants
	Hispanic or Latino	0 0.0%
	Not Hispanic or Latino	9 100.0%
	Unknown or Not Reported	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	7 77.8%
	White	2 22.2%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	9 participants
		9
Body Mass Index; Mean (Standard Deviation); Unit of measure: Kg/m^2
	Number Analyzed	9 participants
		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.
Overall Number of Participants Analyzed	8
Measure Type: Count of Participants; Unit of Measure: Participants
	7 87.5%

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.
Overall Number of Participants Analyzed	8
Mean (Standard Deviation); Unit of Measure: 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.
Overall Number of Participants Analyzed	8
Mean (Standard Deviation); Unit of Measure: 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.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: percentage of day spent sedentary
	-8.1 (4.5)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting 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.
All-Cause Mortality
	NEAT!
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	NEAT!
	Affected / at Risk (%)
Total	0/9 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	NEAT!
	Affected / at Risk (%)
Total	0/9 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

Results Point of Contact

• Name/Title: Christine Pellegrini, PhD
• Organization: Northwestern University
• Phone: 312-503-1395
• EMail: c-pellegrini@northwestern.edu

• Responsible Party: Christine Pellegrini, Northwestern University
• ClinicalTrials.gov Identifier: NCT01754467
• Other Study ID Numbers: CCDTR01
• First Submitted: December 13, 2012
• First Posted: December 21, 2012
• Results First Submitted: January 25, 2017
• Results First Posted: April 28, 2017
• Last Update Posted: April 28, 2017