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Diabetes MellitusPhase 4PREDIASNCT00707447

Evaluation of a Primary Type 2 Diabetes Prevention Programme

A Phase 4 study testing PREDIAS in people with Diabetes Mellitus, run by Forschungsinstitut der Diabetes Akademie Mergentheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus
What is being tested?
PREDIAS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
182 participants
Where
1 siteGermany
Study dates
Apr 2004to May 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • impaired fasting glucose and/or
  • impaired glucose tolerance
  • overweight (BMI > 26 kg/m²)

Who cannot join

  • type 2 diabetes
  • severe illness (cancer diagnosis, stroke or myocardial infarction in the last 12 months)
  • diagnosis of a current mental disease

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Research Institute of the Diabetes Academy Mergentheim (FIDAM)

    Bad Mergentheim, D-97980

Other trials in Germany

About this study

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

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

Read the 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.

Being tested
PREDIAS, Control
Keywords
diabetes-prevention, lifestyle modification, behavior therapy, self-management
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PREDIASBehavioural

    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

  • ControlBehavioural

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

Study groups in NCT00707447
Study groupRoleWhat they receive
1/ControlPlacebo comparatorControl group received written information about diabetes risks with instructions about healthy eating and increasing physical exercise
Receives: Behavioral: Control
2/PREDIASExperimentalIntervention consists of a group programme (PREDIAS) aiming at modification of lifestyle
Receives: Behavioral: PREDIAS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight Change

    Mean weight change (in kg) after 12 months

    Measured: 12 month

  2. Waist Circumference

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

    Measured: 12 months

Secondary outcomes (8)

  1. Fasting Glucose

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

    Measured: 12 months

  2. Glucose Tolerance

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

    Measured: 12 months

  3. Physical Exercise

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

    Measured: 12 months

  4. 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

    Measured: 12 months

  5. 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

    Measured: 12 months

  6. 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

    Measured: 12 months

  7. 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

    Measured: 12 months

  8. 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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2008 (estimated)
  2. Study startApr 2004
  3. Primary completionDec 2005
  4. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00707447
Sponsor's protocol ID
FIDAM 006-04
Acronym
PREDIAS
Status last verified
Aug 2014
First submitted
26 Jun 2008
Last updated
25 Aug 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 19509014

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PREDIAS in people with Diabetes Mellitus, run by Forschungsinstitut der Diabetes Akademie Mergentheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Change (time frame: 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00707447, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2014.

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