Diabetes Mellitus
Conditions
Keywords
diabetes-prevention, lifestyle modification, behavior therapy, self-management
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.
Interventions
BEHAVIORALPREDIAS
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
BEHAVIORALControl
Written Information about diabetes risks. Brochure about the value of a healthy lifestyle, calorie table, suggestions for healthy food and daily exercise
Sponsors
Technische Universität Dresden
Forschungsinstitut der Diabetes Akademie Mergentheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Physical Exercise | 12 months | Mean changes in physical exercise (in min/week) 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) - 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 |
| Fasting Glucose | 12 months | Mean changes in fasting glucose (in mg/dl) after 12 month |
| 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 |
| 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 |
| 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 |
| Glucose Tolerance | 12 months | Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1/Control Control group received written instruction about healthy eating and increasing physical exercise | 89 |
| 2/PREDIAS Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle | 93 |
| Total | 182 |
Baseline characteristics
| Characteristic | 2/PREDIAS | 1/Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 17 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants | 72 Participants | 152 Participants |
| Age, Continuous | 56.6 years STANDARD_DEVIATION 9.6 | 55.9 years STANDARD_DEVIATION 10.7 | 56.2 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment Germany | 93 participants | 89 participants | 182 participants |
| Sex: Female, Male Female | 38 Participants | 40 Participants | 78 Participants |
| Sex: Female, Male Male | 55 Participants | 49 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 81 | 0 / 85 |
| serious Total, serious adverse events | 0 / 81 | 0 / 85 |
Outcome results
Primary
Waist Circumference
Mean change in waist circumference (in cm) after 12 months
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention Group (PREDIAS) | Waist Circumference | -4.1 cm | Standard Deviation 6 |
| Control Group | Waist Circumference | -0.4 cm | Standard Deviation 6.2 |
Comparison: independent t-tests for between group comparisons, dependent t-tests for within group comparisonsp-value: <0.05t-test, 2 sided
Primary
Weight Change
Mean weight change (in kg) after 12 months
Time frame: 12 month
Population: Intention to treat analysis (LOCF) and per protocol analysis for primary outcome and per protocol analysis for secondary outcome measures
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention Group (PREDIAS) | Weight Change | -3.8 kg | Standard Deviation 5.2 |
| Control Group | Weight Change | -1.4 kg | Standard Deviation 4 |
Comparison: independent t-tests for between group comparisons, dependent t-tests for within group comparisonsp-value: <0.05t-test, 2 sided
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
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention Group (PREDIAS) | Eating Behavior (TFEQ) - Cognitive Restraint | 3.9 units on a scale | Standard Deviation 3.8 |
| Control Group | Eating Behavior (TFEQ) - Cognitive Restraint | 1.5 units on a scale | Standard Deviation 3 |
p-value: <0.05t-test, 2 sided
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
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention Group (PREDIAS) | Eating Behavior (TFEQ) - Disinhibition | -1.2 units on a scale | Standard Deviation 2.7 |
| Control Group | Eating Behavior (TFEQ) - Disinhibition | -0.4 units on a scale | Standard Deviation 2.6 |
p-value: <0.05t-test, 2 sided
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
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention Group (PREDIAS) | Eating Behavior (TFEQ) - Hunger | -1.1 units on a scale | Standard Deviation 3.1 |
| Control Group | Eating Behavior (TFEQ) - Hunger | -0.2 units on a scale | Standard Deviation 2.7 |
p-value: <0.05t-test, 2 sided
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
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention Group (PREDIAS) | Emotional Well-being/ Depression (CES-D) | -3.5 units on a scale | Standard Deviation 7.1 |
| Control Group | Emotional Well-being/ Depression (CES-D) | -1.0 units on a scale | Standard Deviation 6.1 |
p-value: <0.05t-test, 2 sided
Secondary
Fasting Glucose
Mean changes in fasting glucose (in mg/dl) after 12 month
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention Group (PREDIAS) | Fasting Glucose | -4.3 mg/dl | Standard Deviation 11.3 |
| Control Group | Fasting Glucose | 1.8 mg/dl | Standard Deviation 13.1 |
p-value: <0.05t-test, 2 sided
Secondary
Glucose Tolerance
Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention Group (PREDIAS) | Glucose Tolerance | -7.3 mg/dl | Standard Deviation 30.8 |
| Control Group | Glucose Tolerance | -8.2 mg/dl | Standard Deviation 36.9 |
p-value: <0.05t-test, 2 sided
Secondary
Physical Exercise
Mean changes in physical exercise (in min/week) after 12 months
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention Group (PREDIAS) | Physical Exercise | 46.6 minutes per week | Standard Deviation 95.5 |
| Control Group | Physical Exercise | 17.9 minutes per week | Standard Deviation 63.8 |
p-value: <0.05t-test, 2 sided
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
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention Group (PREDIAS) | Psychological Well-being (WHO-5) | 1.4 units on a scale | Standard Deviation 3.9 |
| Control Group | Psychological Well-being (WHO-5) | 0.0 units on a scale | Standard Deviation 4.2 |
p-value: <0.05t-test, 2 sided