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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christine Pellegrini, Northwestern University
ClinicalTrials.gov Identifier:
NCT01754467
First received: December 13, 2012
Last updated: April 26, 2017
Last verified: April 2017
Results First Received: January 25, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Diabetes Mellitus
Intervention: Behavioral: NEAT!

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were only excluded if they did not meet the eligibility criteria or were no longer interested in participating.

Reporting Groups
  Description
NEAT!

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.


Participant Flow:   Overall Study
    NEAT!
STARTED   9 
COMPLETED   8 
NOT COMPLETED   1 
Lost to Follow-up                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
NEAT!

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.


Baseline Measures
   NEAT! 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      7  77.8% 
>=65 years      2  22.2% 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.1  (10.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7  77.8% 
Male      2  22.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      9 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
 
United States   9 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 37.4  (9.9) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Acceptability of NEAT!   [ Time Frame: 1 month ]

2.  Secondary:   Adherence to NEAT!   [ Time Frame: 1 Month ]

3.  Secondary:   Breaks in Sedentary Behavior   [ Time Frame: Baseline and 1 month ]

4.  Secondary:   Changes in Total Sedentary Time   [ Time Frame: Baseline and 1 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: c-pellegrini@northwestern.edu



Responsible Party: Christine Pellegrini, Northwestern University
ClinicalTrials.gov Identifier: NCT01754467     History of Changes
Other Study ID Numbers: CCDTR01
Study First Received: December 13, 2012
Results First Received: January 25, 2017
Last Updated: April 26, 2017