Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of a Primary Type 2 Diabetes Prevention Programme (PREDIAS)

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.
 
ClinicalTrials.gov Identifier: NCT00707447
Recruitment Status : Completed
First Posted : June 30, 2008
Results First Posted : August 25, 2014
Last Update Posted : August 25, 2014
Sponsor:
Collaborator:
Technische Universität Dresden
Information provided by (Responsible Party):
Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
A type 2 diabetes prevention programme, named PREDIAS was developed. It consists of 12 lessons delivered as group sessions. Die efficacy of PREDIAS 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 or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: PREDIAS Behavioral: Control Phase 4

Detailed Description:
The PREDIAS 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 PREDIAS was to develop a prevention programme delivered as a group programme to improve cost-benefit ration of diabetes prevention programmes.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of a Teaching and Treatment Programme for Primary Prevention of Type 2 Diabetes
Study Start Date : April 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: 1/Control
Control group received written information about diabetes risks with instructions about healthy eating and increasing physical exercise
 Behavioral: Control
Written Information about diabetes risks. Brochure about the value of a healthy lifestyle, calorie table, suggestions for healthy food and daily exercise
Experimental: 2/PREDIAS
Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle
 Behavioral: PREDIAS
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Weight Change [ Time Frame: 12 month ]
    Mean weight change (in kg) after 12 months

  2. Waist Circumference [ Time Frame: 12 months ]
    Mean change in waist circumference (in cm) after 12 months


Secondary Outcome Measures :
  1. Fasting Glucose [ Time Frame: 12 months ]
    Mean changes in fasting glucose (in mg/dl) after 12 month

  2. Glucose Tolerance [ Time Frame: 12 months ]
    Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months

  3. Physical Exercise [ Time Frame: 12 months ]
    Mean changes in physical exercise (in min/week) after 12 months

  4. Eating Behavior (TFEQ) - Cognitive Restraint [ Time Frame: 12 months ]

    The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale "cognitive restraint" consists of 21 Item with a minimum score of "0" and a maximum score of "21". Low scores indicate an uninhibited eating behavior.

    Mean change in the TFEQ - cognitive restraint scale after 12 months


  5. Eating Behavior (TFEQ) - Disinhibition [ Time Frame: 12 months ]

    The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale "disinhibition" consists of 16 Item with a minimum score of "0" and a maximum score of "16". High scores indicate an uninhibited eating behavior strongly depending on external cues.

    Mean change in the TFEQ - disinhibition scale after 12 months


  6. Eating Behavior (TFEQ) - Hunger [ Time Frame: 12 months ]

    The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale "hunger" consists of 14 Item with a minimum score of "0" and a maximum score of "14". Low scores indicate an eating behavior strongly depending on feelings of hunger.

    Mean change in the TFEQ - hunger scale after 12 months


  7. Psychological Well-being (WHO-5) [ Time Frame: 12 months ]

    The WHO (Five) Well-being index consists of 5 items on the overall well-being over the last two weeks. Each of the five items is rated from 0 (= not present) to 5 (= constantly present). Scores are summated, with raw score ranging from 0 to 25. Then the scores are transformed to 0-100 by multiplying by 4, with higher scores meaning better well-being.

    Mean change in psychological well-being score (WHO-5) after 12 months


  8. Emotional Well-being/ Depression (CES-D) [ Time Frame: 12 months ]

    The Center for Epidemiologic Studies Depression Scale (CES-D) consists of 20 items scored from "0" to "3". Scores are summated, with raw score ranging from 0 to 25. Higher Scores idicate a higher depressive state.

    Mean change in depression score (CES-D) after 12 months



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • impaired fasting glucose and/or
  • impaired glucose tolerance
  • overweight (BMI > 26 kg/m²)

Exclusion Criteria:

  • type 2 diabetes
  • severe illness (cancer diagnosis, stroke or myocardial infarction in the last 12 months)
  • diagnosis of a current mental disease
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707447


Locations
Layout table for location information
Germany
Research Institute of the Diabetes Academy Mergentheim (FIDAM)
Bad Mergentheim, Germany, D-97980
Sponsors and Collaborators
Forschungsinstitut der Diabetes Akademie Mergentheim
Technische Universität Dresden
Investigators
Layout table for investigator information
Principal Investigator: Norbert Hermanns, PhD Forschungsinstitut der Diabetes Akademie Mergentheim
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Norbert Hermanns, PhD, Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier: NCT00707447    
Other Study ID Numbers: FIDAM 006-04
First Posted: June 30, 2008    Key Record Dates
Results First Posted: August 25, 2014
Last Update Posted: August 25, 2014
Last Verified: August 2014
Keywords provided by Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim:
diabetes-prevention
lifestyle modification
behavior therapy
self-management
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases