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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
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus
 Behavioral: PRAEDIAS (group programme aiming at modification of lifestyle)
Behavioral: Written Information about diabetes risks
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of a Teaching and Treatment Programme for Primary Prevention of Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Forschungsinstitut der Diabetes Akademie Mergentheim:

Primary Outcome Measures:
  • Weight reduction [ Time Frame: baseline, after 2months, after 6 months, after 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 164
Study Start Date: April 2004
Study Completion Date: May 2008
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Control group received written instruction about healthy eating and increasing physical exercise
 Behavioral: Written Information about diabetes risks
Brochure about the value of a healthy lifestyle, calorie table, suggestions for healthy food and daily exercise
Experimental: 2
Intervention consists of a group programme (PRAEDIAS) aiming at modification of lifestyle
 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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707447

Locations
Germany
Research Institute of the Diabetes Academy (FIDAM)
Bad Mergentheim, D, Germany, 97980
Sponsors and Collaborators
Forschungsinstitut der Diabetes Akademie Mergentheim
Dresden University of Technology
  More Information

No publications provided by Forschungsinstitut der Diabetes Akademie Mergentheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Dr. Norbert Hermanns, FIDAM
ClinicalTrials.gov Identifier: NCT00707447     History of Changes
Other Study ID Numbers: FIDAM 006-04
Study First Received: June 26, 2008
Last Updated: June 27, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Forschungsinstitut der Diabetes Akademie Mergentheim:
Diabetes-prevention
lifestyle modification
behavior therapy
selfmanagement

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013