NCT00985179

Brief Summary

To help employees to adopt and maintain a healthy lifestyle, it is imperative to increase their self-management competencies. Aim of this research project is to evaluate an evidence- and theory-based computerized expert system in comparison to waiting control group. Employees will be treated psychologically and followed up over 18 months. The computerized expert system is expected to help employees significantly changing their lifestyle. The intervention is hypothesized to improve self-management competencies over and above the regular check-up at their medical appointment (i.e., waiting control group).

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

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

November 14, 2012

Status Verified

June 1, 2011

Enrollment Period

2.3 years

First QC Date

September 24, 2009

Last Update Submit

November 12, 2012

Conditions

Keywords

Randomized Controlled Trialevidence- and theory-based behavioral interventionexpert systemstages of changemotivational interviewingtailoringSelf CareExpert Systems

Outcome Measures

Primary Outcomes (1)

  • health behavior (physical activity & fruits and vegetables)

    13 weeks

Secondary Outcomes (6)

  • subjective health

    13 weeks

  • work satisfaction

    13 weeks

  • motivation/volition

    13 weeks

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

    13 weeks

  • objective health measures (body mass index, cholesterol, blood glucose ect.)

    13 weeks

  • +1 more secondary outcomes

Study Arms (2)

Intervention Group (IG)

EXPERIMENTAL

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

Behavioral: Intervention Group (IG)

Waiting control group (WCG)

NO INTERVENTION

Interventions

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

Also known as: HAPA-based stage-matched intervention
Intervention Group (IG)

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Heart DiseasesDiabetes Mellitus, Type 2Behavior

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Anna Ernsting

    Freie Universitaet Berlin

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 24, 2009

First Posted

September 28, 2009

Study Start

October 1, 2009

Primary Completion

January 1, 2012

Study Completion

March 1, 2012

Last Updated

November 14, 2012

Record last verified: 2011-06

Locations