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A Lifestyle Change Program to Prevent Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00886340
First Posted: April 22, 2009
Last Update Posted: May 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robin Whittemore, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Results First Submitted: January 22, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Prediabetes
Interventions: Behavioral: Enhanced standard care
Behavioral: Lifestyle counseling

  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
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Reporting Groups
  Description
Enhanced Standard Care Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
Lifestyle Counseling Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)

Participant Flow:   Overall Study
    Enhanced Standard Care   Lifestyle Counseling
STARTED   27   31 
COMPLETED   27   24 
NOT COMPLETED   0   7 
Withdrawal by Subject                0                7 



  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.
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Reporting Groups
  Description
Enhanced Standard Care Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
Lifestyle Counseling Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
Total Total of all reporting groups

Baseline Measures
   Enhanced Standard Care   Lifestyle Counseling   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   31   58 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   26   27   53 
>=65 years   1   4   5 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.2  (13.2)   48.2  (12.4)   45.7  (12.7) 
Gender 
[Units: Participants]
     
Female   24   28   52 
Male   3   3   6 


  Outcome Measures

1.  Primary:   Number of Participants Who Met Weight Loss Goal of 5% Weight Loss   [ Time Frame: 6 months ]

2.  Secondary:   Diet and Exercise Behavior   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Lipids   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Quality of Life   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT 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.


Results Point of Contact:  
Name/Title: Robin Whittemore, PhD
Organization: Yale School of Nursing
phone: 203-737-2351
e-mail: robin.whittemore@yale.edu


Publications of Results:

Responsible Party: Robin Whittemore, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00886340     History of Changes
Other Study ID Numbers: DK70594 (completed)
First Submitted: January 22, 2009
First Posted: April 22, 2009
Results First Submitted: January 22, 2009
Results First Posted: April 22, 2009
Last Update Posted: May 7, 2012