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| Name | Class |
|---|---|
| Technische Universität Dresden | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1/Control | Placebo Comparator | Control group received written information about diabetes risks with instructions about healthy eating and increasing physical exercise |
|
| 2/PREDIAS | Experimental | Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PREDIAS | Behavioral | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norbert Hermanns, PhD | Forschungsinstitut der Diabetes Akademie Mergentheim | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of the Diabetes Academy Mergentheim (FIDAM) | Bad Mergentheim | D-97980 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19509014 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1/Control | Control group received written instruction about healthy eating and increasing physical exercise |
| FG001 | 2/PREDIAS | Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1/Control | Control group received written instruction about healthy eating and increasing physical exercise |
| BG001 | 2/PREDIAS | Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Change | Mean weight change (in kg) after 12 months | Intention to treat analysis (LOCF) and per protocol analysis for primary outcome and per protocol analysis for secondary outcome measures | Posted | Mean | Standard Deviation | kg | 12 month |
|
12 months
The occurence of (serious) adverse events was assessed at each visit and at study close-out visit after 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1/Control | Control group received written instruction about healthy eating and increasing physical exercise |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Norbert Hermanns | FIDAM | 0049 7931 594 | 553 | hermanns@diabetes-zentrum.de |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| Control | Behavioral | Written Information about diabetes risks. Brochure about the value of a healthy lifestyle, calorie table, suggestions for healthy food and daily exercise |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Waist Circumference | Mean change in waist circumference (in cm) after 12 months | Posted | Mean | Standard Deviation | cm | 12 months |
|
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|
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| Secondary | Fasting Glucose | Mean changes in fasting glucose (in mg/dl) after 12 month | Posted | Mean | Standard Deviation | mg/dl | 12 months |
|
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|
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| Secondary | Glucose Tolerance | Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months | Posted | Mean | Standard Deviation | mg/dl | 12 months |
|
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| Secondary | Physical Exercise | Mean changes in physical exercise (in min/week) after 12 months | Posted | Mean | Standard Deviation | minutes per week | 12 months |
|
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|
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| 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 | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| EG001 | 2/PREDIAS | Intervention consists of a group programme (PRAEDIAS) aiming at modification of lifestyle | 0 | 85 | 0 | 85 |
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