Text Size

A Lifestyle Change Program to Prevent Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robin Whittemore, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00886340
First received: January 22, 2009
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
Results First Received: January 22, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Prediabetes
Interventions: Behavioral: Enhanced standard care
Behavioral: Lifestyle counseling

  Participant Flow
  Hide Participant Flow

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
No text entered.

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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 ]
  Show Outcome Measure 1

2.  Secondary:   Diet and Exercise Behavior   [ Time Frame: 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Lipids   [ Time Frame: 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Quality of Life   [ Time Frame: 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame 9 months
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

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)

Other Adverse Events
    Enhanced Standard Care     Lifestyle Counseling  
Total, other (not including serious) adverse events      
# participants affected / at risk     0/27     0/31  



  More Information
  Hide More Information

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.


Limitations and Caveats
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.  


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)
Study First Received: January 22, 2009
Results First Received: January 22, 2009
Last Updated: April 4, 2012
Health Authority: United States: Federal Government