Evaluation of a Primary Type II Diabetes Prevention Programme (PRAEDIAS)

This study has been completed.

Sponsor:

Collaborator:

Dresden University of Technology

Information provided by:

Forschungsinstitut der Diabetes Akademie Mergentheim

ClinicalTrials.gov Identifier:

NCT00707447

First received: June 26, 2008

Last updated: June 27, 2008

Last verified: June 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	June 26, 2008
Last Updated Date	June 27, 2008
Start Date ^ICMJE	April 2004
Primary Completion Date	December 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 27, 2008)	Weight reduction [ Time Frame: baseline, after 2months, after 6 months, after 12 month ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00707447 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 27, 2008)	Fasting glucose [ Time Frame: baseline, after 2 months, after 6 months, after 12 months ] [ Designated as safety issue: No ] lipids [ Time Frame: baseline, after 2 months, after 6 months, after 12 months ] [ Designated as safety issue: No ] eating and exercise behavior [ Time Frame: baseline, after 2 months, after 6 months, after 12 months ] [ Designated as safety issue: No ] Glucose tolerance [ Time Frame: baseline, after 12 months ] [ Designated as safety issue: Yes ] Blood pressure [ Time Frame: baseline, after 2 months, after 6 months, after 12 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Evaluation of a Primary Type II Diabetes Prevention Programme
Official Title ^ICMJE	Evaluation of a Teaching and Treatment Programme for Primary Prevention of Type 2 Diabetes
Brief Summary	A type II diabetes prevention programme, named PRAEDIAS was developed. It consists of 12 lessons delivered as group sessions. Die efficacy of PRAEDIAS was studied in a randomized controlled study with 12 month follow up. Control group received written information about diabetes risk. Primary outcome variable was weight reduction at 12 months follow up. Secondary variables were impact of the intervention on glycemic parameters, lipids, eating and exercise behavior and other metabolic risk factors
Detailed Description	The PRAEDIAS programme was developed based on the interventions used in the Diabetes prevention study (DPS, Finland) and the Diabetes Prevention programme (DPP; USA). The main purpose of PRAEDIAS was to develop a prevention programme delivered as a group programme to improve cost-benefit ration of diabetes prevention programmes.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Diabetes Mellitus
Intervention ^ICMJE	Behavioral: PRAEDIAS (group programme aiming at modification of lifestyle) Lifestyle changes, 12 lesson a 90 minutes, delivered in a group setting, consists of analysis of barriers against lifestyle changes, behavior analysis of eating and exercise behavior, modification of unhealthy lifestyle and relapse prevention Behavioral: Written Information about diabetes risks Brochure about the value of a healthy lifestyle, calorie table, suggestions for healthy food and daily exercise
Study Arm (s)	Placebo Comparator: 1 Control group received written instruction about healthy eating and increasing physical exercise Intervention: Behavioral: Written Information about diabetes risks Experimental: 2 Intervention consists of a group programme (PRAEDIAS) aiming at modification of lifestyle Intervention: Behavioral: PRAEDIAS (group programme aiming at modification of lifestyle)
Publications *	Kulzer B, Hermanns N, Gorges D, Schwarz P, Haak T. Prevention of diabetes self-management program (PREDIAS): effects on weight, metabolic risk factors, and behavioral outcomes. Diabetes Care. 2009 Jul;32(7):1143-6. Epub 2009 Jun 9.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	164
Completion Date	May 2008
Primary Completion Date	December 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: impaired fasting glucose and/or impaired glucose tolerance overweight (BMI > 26 kg/m²) Exclusion Criteria: type II diabetes severe illness (cancer diagnosis, stroke or MI in the last 12 months) diagnosis of a current mental disease
Gender	Both
Ages	20 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT00707447
Other Study ID Numbers ^ICMJE	FIDAM 006-04
Has Data Monitoring Committee	No
Responsible Party	Prof. Dr. Norbert Hermanns, FIDAM
Study Sponsor ^ICMJE	Forschungsinstitut der Diabetes Akademie Mergentheim
Collaborators ^ICMJE	Dresden University of Technology
Investigators ^ICMJE
Information Provided By	Forschungsinstitut der Diabetes Akademie Mergentheim
Verification Date	June 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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