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NCT Number: NCT00707447

Evaluation of a Primary Type 2 Diabetes Prevention Programme

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Institute of the Diabetes Academy Mergentheim (FIDAM)

Bad Mergentheim, D-97980, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Control

Behavioral

Written Information about diabetes risks. Brochure about the value of a healthy lifestyle, calorie table, suggestions for healthy food and daily exercise

Primary outcomes

  1. Weight Change

    Time frame: 12 month

    Mean weight change (in kg) after 12 months

  2. Waist Circumference

    Time frame: 12 months

    Mean change in waist circumference (in cm) after 12 months

Secondary outcomes

  1. Fasting Glucose

    Time frame: 12 months

    Mean changes in fasting glucose (in mg/dl) after 12 month

  2. Glucose Tolerance

    Time frame: 12 months

    Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months

  3. Physical Exercise

    Time frame: 12 months

    Mean changes in physical exercise (in min/week) after 12 months

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Forschungsinstitut der Diabetes Akademie Mergentheim

Other

Collaborators

  • Technische Universität Dresden

Registry information

Official study title

Evaluation of a Teaching and Treatment Programme for Primary Prevention of Type 2 Diabetes

Acronym: PREDIAS

Important dates

Study start
2004
Primary completion
2005
Study completion
2008
First posted
Jun 30, 2008
Registry last updated
Aug 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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