Evaluation of a Primary Type II Diabetes Prevention Programme - Full Text View

Sponsors and Collaborators:	Forschungsinstitut der Diabetes Akademie Mergentheim Dresden University of Technology
Information provided by:	Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier:	NCT00707447

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 IV

MedlinePlus related topics: Diabetes Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Evaluation of a Teaching and Treatment Programme for Primary Prevention of Type 2 Diabetes

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
1: Placebo Comparator 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
2: Experimental 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, D
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

Responsible Party:	FIDAM ( Prof. Dr. Norbert Hermanns )
Study ID Numbers:	FIDAM 006-04
Study First Received:	June 26, 2008
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00707447
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

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009