Evaluation of a Primary Type 2 Diabetes Prevention Programme

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: PREDIAS
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Change | Mean weight change (in kg) after 12 months | 12 month | 
| Waist Circumference | Mean change in waist circumference (in cm) after 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Glucose | Mean changes in fasting glucose (in mg/dl) after 12 month | 12 months | 
| Glucose Tolerance | Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months | 12 months | 
| Physical Exercise | Mean changes in physical exercise (in min/week) after 12 months | 12 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes-prevention, lifestyle modification, behavior therapy, self-management