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

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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:
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
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!
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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
Arm/Group Title NEAT!
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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
Hide 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)
1.Primary Outcome
Title Acceptability of NEAT!
Hide Description How many participants would continue to use or use NEAT! in the future
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NEAT!
Hide 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!
Hide Description NEAT usage (days/month)
Time Frame 1 Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NEAT!
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NEAT!
Hide 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
Hide Description Changes in total sedentary behavior will be assessed via accelerometry between baseline and 1 month
Time Frame Baseline and 1 month
Hide Outcome Measure Data
Hide 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!
Hide 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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NEAT!
Hide 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   --/-- 
Hide Serious Adverse Events
NEAT!
Affected / at Risk (%)
Total   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
NEAT!
Affected / at Risk (%)
Total   0/9 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christine Pellegrini, PhD
Organization: Northwestern University
Phone: 312-503-1395
EMail: c-pellegrini@northwestern.edu
Layout table for additonal information
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