NCT00707447

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_4 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2008

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

August 25, 2014

Completed
Last Updated

August 25, 2014

Status Verified

August 1, 2014

Enrollment Period

1.7 years

First QC Date

June 26, 2008

Results QC Date

September 3, 2012

Last Update Submit

August 8, 2014

Conditions

Diabetes Mellitus

Keywords

diabetes-preventionlifestyle modificationbehavior therapyself-management

Outcome Measures

Primary Outcomes (2)

  • Weight Change

    Mean weight change (in kg) after 12 months

    12 month

  • Waist Circumference

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

    12 months

Secondary Outcomes (8)

  • Fasting Glucose

    12 months

  • Glucose Tolerance

    12 months

  • Physical Exercise

    12 months

  • Eating Behavior (TFEQ) - Cognitive Restraint

    12 months

  • Eating Behavior (TFEQ) - Disinhibition

    12 months

  • +3 more secondary outcomes

Study Arms (2)

1/Control

PLACEBO COMPARATOR

Control group received written information about diabetes risks with instructions about healthy eating and increasing physical exercise

Behavioral: Control

2/PREDIAS

EXPERIMENTAL

Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle

Behavioral: PREDIAS

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

2/PREDIAS
ControlBEHAVIORAL

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

1/Control

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute of the Diabetes Academy Mergentheim (FIDAM)

Bad Mergentheim, D-97980, Germany

Location

Related Publications (1)

  • 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.

    PMID: 19509014RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Norbert Hermanns
Organization
FIDAM
hermanns@diabetes-zentrum.de
0049 7931 594

Study Officials

  • Norbert Hermanns, PhD

    Forschungsinstitut der Diabetes Akademie Mergentheim

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 26, 2008

First Posted

June 30, 2008

Study Start

April 1, 2004

Primary Completion

December 1, 2005

Study Completion

May 1, 2008

Last Updated

August 25, 2014

Results First Posted

August 25, 2014

Record last verified: 2014-08

Locations

DE(1)