Evaluation of a Primary Type 2 Diabetes Prevention Programme (PREDIAS)
Evaluation of a Teaching and Treatment Programme for Primary Prevention of Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Bad Mergentheim, Germany, D-97980
- Research Institute of the Diabetes Academy Mergentheim (FIDAM)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
PLACEBO_COMPARATOR: 1/Control
Control group received written information about diabetes risks with instructions about healthy eating and increasing physical exercise
|
Written Information about diabetes risks.
Brochure about the value of a healthy lifestyle, calorie table, suggestions for healthy food and daily exercise
|
|
EXPERIMENTAL: 2/PREDIAS
Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight Change
Time Frame: 12 month
|
Mean weight change (in kg) after 12 months
|
12 month
|
|
Waist Circumference
Time Frame: 12 months
|
Mean change in waist circumference (in cm) after 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fasting Glucose
Time Frame: 12 months
|
Mean changes in fasting glucose (in mg/dl) after 12 month
|
12 months
|
|
Glucose Tolerance
Time Frame: 12 months
|
Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months
|
12 months
|
|
Physical Exercise
Time Frame: 12 months
|
Mean changes in physical exercise (in min/week) after 12 months
|
12 months
|
|
Eating Behavior (TFEQ) - Cognitive Restraint
Time Frame: 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 |
12 months
|
|
Eating Behavior (TFEQ) - Disinhibition
Time Frame: 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 |
12 months
|
|
Eating Behavior (TFEQ) - Hunger
Time Frame: 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 |
12 months
|
|
Psychological Well-being (WHO-5)
Time Frame: 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 |
12 months
|
|
Emotional Well-being/ Depression (CES-D)
Time Frame: 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 |
12 months
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIDAM 006-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.