Translating the DPP Into the Community

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
RAckermann, Northwestern University
ClinicalTrials.gov Identifier:
NCT00302042
First received: March 10, 2006
Last updated: August 5, 2014
Last verified: August 2014
Results First Received: May 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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
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
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  
Number of Participants  
[units: participants]
  46     46     92  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     45     43     88  
>=65 years     1     3     4  
Age  
[units: years]
Mean ± Standard Deviation
  56.5  ± 9.7     60.1  ± 10.5     58.3  ± 10.1  
Gender  
[units: participants]
     
Female     23     28     51  
Male     23     18     41  
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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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

4.  Secondary:   Change in Dietary Composition   [ Time Frame: Baseline, 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
.


  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


No publications provided


Responsible Party: RAckermann, Northwestern University
ClinicalTrials.gov Identifier: NCT00302042     History of Changes
Other Study ID Numbers: DK70702 (completed), R34DK070702
Study First Received: March 10, 2006
Results First Received: May 23, 2013
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government