NCT00986375

Brief Summary

The purpose of this study is to help Internet users to adopt and maintain a healthy lifestyle, it is imperative to increase self-management competencies to improve healthy eating and regular physical activity. Aim of this research project is to evaluate an evidence- and theory-based computerized expert system in comparison to a standard program. In addition, two different tailoring criteria are compared to each other with regard to the misclassification of study participants. Internet users will be treated psychologically and followed up over 12 weeks. The computerized expert system is expected to help users better than the standard program. Both interventions are hypothesized to improve self-management competencies over time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2009

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

First Submitted

Initial submission to the registry

September 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 14, 2012

Status Verified

February 1, 2011

Enrollment Period

11 months

First QC Date

September 29, 2009

Last Update Submit

November 12, 2012

Conditions

Diabetes Mellitus, Type 2

Keywords

Randomized Controlled Trialevidence- and theory-based behavioral interventionexpert systemstages of changemotivational interviewingtailoringSelf CareRehabilitationExpert SystemsBehaviorMotivation

Outcome Measures

Primary Outcomes (1)

  • physical activity fruit & vegetable consumption

    12 weeks

Secondary Outcomes (4)

  • subjective health & well-being

    12 weeks

  • motivation/volition

    12 weeks

  • social-cognitive predictors of behavior (self-efficacy, action control etc.)

    12 weeks

  • intervention engagement

    12 weeks

Study Arms (2)

Intervention Group (IG)

EXPERIMENTAL

Patients in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients

Behavioral: Intervention Group (IG)

Active Control Group (ACG)

ACTIVE COMPARATOR

Patients in the ACG will get an interactive computerized standard program

Behavioral: Active Control Group (ACG)

Interventions

Intervention Group (IG)BEHAVIORAL

patients will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients

Intervention Group (IG)
Active Control Group (ACG)BEHAVIORAL

Patients in the ACG will get an interactive computerized standard program

Active Control Group (ACG)

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • to be capable of exercising on their own at a minimum level and/or to consume fruits and vegetables
  • able to fill out a questionnaire (no illiteracy)
  • adequate German language ability

You may not qualify if:

  • no internet access
  • no computer with keyboard

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Freie Universitaet Berlin

Berlin, State of Berlin, 14195, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Behavior

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ralf Schwarzer, PhD

    Freie Universitaet Berlin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2009

First Posted

September 30, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2010

Study Completion

June 1, 2011

Last Updated

November 14, 2012

Record last verified: 2011-02

Locations

DE(1)