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

This study has been completed.
Sponsor:
Collaborator:
Technische Universität Dresden
Information provided by (Responsible Party):
Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier:
NCT00707447
First received: June 26, 2008
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Diabetes Mellitus
Behavioral: PREDIAS
Behavioral: Control
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:


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

Primary Outcome Measures:
  • Weight Change [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Mean weight change (in kg) after 12 months

  • Waist Circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mean change in waist circumference (in cm) after 12 months


Secondary Outcome Measures:
  • Fasting Glucose [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mean changes in fasting glucose (in mg/dl) after 12 month

  • Glucose Tolerance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months

  • Physical Exercise [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mean changes in physical exercise (in min/week) after 12 months

  • Eating Behavior (TFEQ) - Cognitive Restraint [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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


  • Eating Behavior (TFEQ) - Disinhibition [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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


  • Eating Behavior (TFEQ) - Hunger [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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


  • Psychological Well-being (WHO-5) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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


  • Emotional Well-being/ Depression (CES-D) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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



Enrollment: 182
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
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

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.

  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 2 diabetes
  • severe illness (cancer diagnosis, stroke or myocardial infarction in the last 12 months)
  • diagnosis of a current mental disease
  Contacts and Locations
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, see Learn About Clinical Studies.

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

Locations
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
Principal Investigator: Norbert Hermanns, PhD Forschungsinstitut der Diabetes Akademie Mergentheim
  More Information

Publications:
Responsible Party: Norbert Hermanns, PhD, Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier: NCT00707447     History of Changes
Other Study ID Numbers: FIDAM 006-04
Study First Received: June 26, 2008
Results First Received: September 3, 2012
Last Updated: August 8, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Forschungsinstitut der Diabetes Akademie Mergentheim:
diabetes-prevention
lifestyle modification
behavior therapy
self-management

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014