Evaluation of a Primary Type 2 Diabetes Prevention Programme

NCT00707447 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2014-08-25

Study results available
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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

Conditions

Interventions

BEHAVIORAL

PREDIAS

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

BEHAVIORAL

Control

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

Sponsors & Collaborators

  • Technische Universität Dresden

    collaborator OTHER
  • Forschungsinstitut der Diabetes Akademie Mergentheim

    lead OTHER

Principal Investigators

  • Norbert Hermanns, PhD · Forschungsinstitut der Diabetes Akademie Mergentheim

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2005-12-31
Completion
2008-05-31

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00707447 on ClinicalTrials.gov