Evaluation of a Primary Type 2 Diabetes Prevention Programme

Phase 4

Completed

Conditions: Diabetes Mellitus

Interventions: Behavioral: Control
Behavioral: PREDIAS

Registration Number: NCT00707447

Lead Sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 182

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1/Control	Control	Control group received written information about diabetes risks with instructions about healthy eating and increasing physical exercise
2/PREDIAS	PREDIAS	Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle

Primary Outcome Measures

Name	Time	Method
Weight Change	12 month	Mean weight change (in kg) after 12 months
Waist Circumference	12 months	Mean change in waist circumference (in cm) after 12 months

Secondary Outcome Measures

Name	Time	Method
Physical Exercise	12 months	Mean changes in physical exercise (in min/week) after 12 months
Fasting Glucose	12 months	Mean changes in fasting glucose (in mg/dl) after 12 month
Glucose Tolerance	12 months	Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months
Eating Behavior (TFEQ) - Disinhibition	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
Psychological Well-being (WHO-5)	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
Eating Behavior (TFEQ) - Cognitive Restraint	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
Eating Behavior (TFEQ) - Hunger	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
Emotional Well-being/ Depression (CES-D)	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