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Translating the DPP Into the Community

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00302042
First Posted: March 13, 2006
Last Update Posted: July 18, 2017
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.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ronald Ackermann, Northwestern University
Results First Submitted: May 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Prediabetic State
Overweight
Obesity
Interventions: Behavioral: Brief counseling plus group diabetes prevention in community
Behavioral: Brief Counseling for pre-diabetes alone

  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
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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
Experimental: 1: Brief Counseling Plus Group Lifestyle Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
Active Comparator: 2: Brief Counseling Alone Brief Counseling for pre-diabetes alone without access to group lifestyle

Participant Flow:   Overall Study
    Experimental: 1: Brief Counseling Plus Group Lifestyle   Active Comparator: 2: Brief Counseling Alone
STARTED   46   46 
COMPLETED   39   38 
NOT COMPLETED   7   8 



  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
Experimental: 1: Brief Counseling Plus Group Lifestyle Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
Active Comparator: 2: Brief Counseling Alone Brief Counseling for pre-diabetes alone without access to group lifestyle
Total Total of all reporting groups

Baseline Measures
   Experimental: 1: Brief Counseling Plus Group Lifestyle   Active Comparator: 2: Brief Counseling Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 46   46   92 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      45  97.8%      43  93.5%      88  95.7% 
>=65 years      1   2.2%      3   6.5%      4   4.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.5  (9.7)   60.1  (10.5)   58.3  (10.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      23  50.0%      28  60.9%      51  55.4% 
Male      23  50.0%      18  39.1%      41  44.6% 
Region of Enrollment 
[Units: Participants]
     
United States   46   46   92 


  Outcome Measures

1.  Primary:   Change in Weight   [ Time Frame: Baseline, 6 months ]

2.  Secondary:   Physical Activity Level   [ Time Frame: Baseline, 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Rate of Community Program Participation   [ Time Frame: Baseline, 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Change in Dietary Composition   [ Time Frame: Baseline, 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: Dr. Ronald T. Ackermann
Organization: Northwestern University
phone: 3126036400
e-mail: r.ackermann@northwestern.edu



Responsible Party: Ronald Ackermann, Northwestern University
ClinicalTrials.gov Identifier: NCT00302042     History of Changes
Other Study ID Numbers: DK70702 (completed)
R34DK070702 ( U.S. NIH Grant/Contract )
First Submitted: March 10, 2006
First Posted: March 13, 2006
Results First Submitted: May 23, 2013
Results First Posted: July 12, 2013
Last Update Posted: July 18, 2017