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Completed

NCT Number: NCT00985179

Increasing Vitamin Intake and Physical Activity

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).

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Freie Universitaet Berlin

Berlin, State of Berlin, 14195, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Group (IG)

Behavioral

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

Other names: HAPA-based stage-matched intervention

Primary outcomes

  1. health behavior (physical activity & fruits and vegetables)

    Time frame: 13 weeks

Secondary outcomes

  1. subjective health

    Time frame: 13 weeks

  2. work satisfaction

    Time frame: 13 weeks

  3. motivation/volition

    Time frame: 13 weeks

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

    Time frame: 13 weeks

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

    Time frame: 13 weeks

  6. perceived occupational efficiency

    Time frame: 13 weeks

Sponsors and collaborators

Lead sponsor

Freie Universität Berlin

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

Promoting the Adoption and Maintenance of a Physically Active Lifestyle and a Nutrition Rich in Vitamins With the Help of Two Theory-based Computerized Interventions "BI Vit" (Boehringer Ingelheim for a Nutrition Rich in Vitamines) and "BI Active" (Boehringer Ingelheim for Physical Activity) for Employees

Acronym: BIV-BIA

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 28, 2009
Registry last updated
Nov 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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