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Increasing Vitamin Intake and Physical Activity

NCT ID: NCT00985179

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-03-31

Brief Summary

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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).

Detailed Description

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In a change setting (employees having a regular medical appointment), two interventions (one for nutrition change and one for activity change) will follow and assessments over a time period of 12 to 20 weeks will be conducted afterwards. Study participants in the intervention groups receive an interactive, computerized expert system (Intervention Group, IG). Individuals in the waiting control group (WCG) get nothing. Employees (N = 1000) will be recruited at their regular medical appointment. Study participants will be followed up over three measurement points: One to nine weeks after T1, T2 will take place. Five to 13 weeks after T1 the T3 measurement will be conducted.

The hypotheses are: In comparison to the WCG the employees in the IG are expected to have a higher motivation, to adopt a healthy lifestyle, to perform more health behavior and to be less likely to relapse into previous unhealthy routines. Also, IG employees will be healthier as well as they will report more quality of life, more work satisfaction and more occupational efficiency . In comparison to WCG, the IG is also hypothesized to be more effective than the WCG regarding social-cognitive predictors of behavior.

Moreover, the interventions are supposed to be more effective for individuals with more risk factors (obese ect.). After successful evaluation and some adoptions the intervention will be implemented as a self-help program in all eligible employees in the Intranet.

Conditions

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Heart Diseases Diabetes Mellitus, Type 2 Behavior Motivation

Keywords

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Randomized Controlled Trial evidence- and theory-based behavioral intervention expert system stages of change motivational interviewing tailoring Self Care Expert Systems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention Group (IG)

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

Group Type EXPERIMENTAL

Intervention Group (IG)

Intervention Type BEHAVIORAL

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

Waiting control group (WCG)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention Group (IG)

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

Intervention Type BEHAVIORAL

Other Intervention Names

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HAPA-based stage-matched intervention

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* no internet access
* no computer with keyboard
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Freie Universität Berlin

OTHER

Sponsor Role lead

Responsible Party

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Freie Universität Berlin

Principal Investigators

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Anna Ernsting

Role: PRINCIPAL_INVESTIGATOR

Freie Universitaet Berlin

Locations

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Freie Universitaet Berlin

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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BI Vit

Identifier Type: -

Identifier Source: secondary_id

BI Activ

Identifier Type: -

Identifier Source: secondary_id

FU-19-4711-008

Identifier Type: -

Identifier Source: org_study_id