Clinical Trials Directory

Trials / Completed

CompletedNCT00707447

Evaluation of a Primary Type 2 Diabetes Prevention Programme

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
182 (actual)
Sponsor
Forschungsinstitut der Diabetes Akademie Mergentheim · Academic / Other
Sex
All
Age
20 Years – 70 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

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

Timeline

Start date
2004-04-01
Primary completion
2005-12-01
Completion
2008-05-01
First posted
2008-06-30
Last updated
2014-08-25
Results posted
2014-08-25

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT00707447. Inclusion in this directory is not an endorsement.