Evaluation of a Primary Type 2 Diabetes Prevention Programme

Diabetes Mellitus Clinical Trial

— PREDIAS  

Official title:

Evaluation of a Teaching and Treatment Programme for Primary Prevention of Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707447
• Other study ID #: FIDAM 006-04
• Status: Completed
• Phase: Phase 4
• First received: June 26, 2008
• Last updated: August 8, 2014
• Start date: April 2004
• Est. completion date: May 2008

Study information

• Verified date: August 2014
• Source: Forschungsinstitut der Diabetes Akademie Mergentheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: May 2008
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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
• Control
Written Information about diabetes risks. Brochure about the value of a healthy lifestyle, calorie table, suggestions for healthy food and daily exercise

Locations

Country	Name	City	State
Germany	Research Institute of the Diabetes Academy Mergentheim (FIDAM)	Bad Mergentheim

Sponsors (2)

Lead Sponsor	Collaborator
Forschungsinstitut der Diabetes Akademie Mergentheim	Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. doi: 10.2337/dc08-2141. Epub 2009 Jun 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Change	Mean weight change (in kg) after 12 months	12 month	No
Primary	Waist Circumference	Mean change in waist circumference (in cm) after 12 months	12 months	No
Secondary	Fasting Glucose	Mean changes in fasting glucose (in mg/dl) after 12 month	12 months	No
Secondary	Glucose Tolerance	Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months	12 months	Yes
Secondary	Physical Exercise	Mean changes in physical exercise (in min/week) after 12 months	12 months	No
Secondary	Eating Behavior (TFEQ) - Cognitive Restraint	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	12 months	No
Secondary	Eating Behavior (TFEQ) - Disinhibition	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	12 months	No
Secondary	Eating Behavior (TFEQ) - Hunger	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	12 months	No
Secondary	Psychological Well-being (WHO-5)	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	12 months	No
Secondary	Emotional Well-being/ Depression (CES-D)	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	12 months	No