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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
182
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
Written Information about diabetes risks. Brochure about the value of a healthy lifestyle, calorie table, suggestions for healthy food and daily exercise
Research Institute of the Diabetes Academy Mergentheim (FIDAM)
Bad Mergentheim, Germany
Weight Change
Mean weight change (in kg) after 12 months
Time frame: 12 month
Waist Circumference
Mean change in waist circumference (in cm) after 12 months
Time frame: 12 months
Fasting Glucose
Mean changes in fasting glucose (in mg/dl) after 12 month
Time frame: 12 months
Glucose Tolerance
Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months
Time frame: 12 months
Physical Exercise
Mean changes in physical exercise (in min/week) after 12 months
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months