At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 182 enrolled

Drug / intervention

PREDIAS +1 morebehavioral

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00707447

NCT00707447Phase 4Completed

Compare CT.gov

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

Forschungsinstitut der Diabetes Akademie Mergentheim·interventional·Posted Jun 30, 2008·Updated Aug 25, 2014

In Brief

A Phase 4 clinical trial evaluating PREDIAS and Control for Diabetes Mellitus. Completed, enrolled 182 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDiabetes Mellitus

CountriesGermany

CollaboratorsTechnische Universität Dresden

Timeline

Phase 4CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartApr 2004

Primary CompletionDec 2005

Study CompletionMay 2008

First PostedJun 2008

TodayJul 2026

First PostedJun 30, 2008

Enrollment StartApr 1, 2004

Primary CompletionDec 1, 2005

Study CompletionMay 1, 2008

TodayJul 2, 2026

Enrollment to primary: 1.7 yearsPosted 18.0 years ago

Interventions

PREDIASbehavioral

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

Controlbehavioral

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