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Increasing Vitamin Intake and Physical Activity (BIV-BIA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00985179
First Posted: September 28, 2009
Last Update Posted: November 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Boehringer Ingelheim
Information provided by:
Freie Universität Berlin
September 24, 2009
September 28, 2009
November 14, 2012
October 2009
January 2012   (Final data collection date for primary outcome measure)
health behavior (physical activity & fruits and vegetables) [ Time Frame: 13 weeks ]
Same as current
Complete list of historical versions of study NCT00985179 on ClinicalTrials.gov Archive Site
  • subjective health [ Time Frame: 13 weeks ]
  • work satisfaction [ Time Frame: 13 weeks ]
  • motivation/volition [ Time Frame: 13 weeks ]
  • social-cognitive predictors of behavior (self-efficacy, action control etc.) [ Time Frame: 13 weeks ]
  • objective health measures (body mass index, cholesterol, blood glucose ect.) [ Time Frame: 13 weeks ]
  • perceived occupational efficiency [ Time Frame: 13 weeks ]
Same as current
Not Provided
Not Provided
 
Increasing Vitamin Intake and Physical Activity
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
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).

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Heart Diseases
  • Diabetes Mellitus, Type 2
  • Behavior
  • Motivation
Behavioral: Intervention Group (IG)
Employees in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of them
Other Name: HAPA-based stage-matched intervention
  • Experimental: 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: Behavioral: Intervention Group (IG)
  • No Intervention: Waiting control group (WCG)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
March 2012
January 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00985179
FU-19-4711-008
BI Vit
BI Activ
Yes
Not Provided
Not Provided
Sonia Lippke, Dr.; Assistant Professor (C1), Freie Universität Berlin
Freie Universität Berlin
Boehringer Ingelheim
Principal Investigator: Anna Ernsting Freie Universitaet Berlin
Freie Universität Berlin
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP