COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Increasing Vitamin Intake and Physical Activity (BIV-BIA)

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. Identifier: NCT00985179
Recruitment Status : Completed
First Posted : September 28, 2009
Last Update Posted : November 14, 2012
Boehringer Ingelheim
Information provided by:
Freie Universität Berlin

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).

Condition or disease Intervention/treatment Phase
Heart Diseases Diabetes Mellitus, Type 2 Behavior Motivation Behavioral: Intervention Group (IG) Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Study Start Date : October 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : March 2012

Arm Intervention/treatment
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
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

No Intervention: Waiting control group (WCG)

Primary Outcome Measures :
  1. health behavior (physical activity & fruits and vegetables) [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00985179

Layout table for location information
Freie Universitaet Berlin
Berlin, Germany, 14195
Sponsors and Collaborators
Freie Universität Berlin
Boehringer Ingelheim
Layout table for investigator information
Principal Investigator: Anna Ernsting Freie Universitaet Berlin
Layout table for additonal information
Responsible Party: Sonia Lippke, Dr.; Assistant Professor (C1), Freie Universität Berlin Identifier: NCT00985179    
Other Study ID Numbers: FU-19-4711-008
BI Vit
BI Activ
First Posted: September 28, 2009    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: June 2011
Keywords provided by Freie Universität Berlin:
Randomized Controlled Trial
evidence- and theory-based behavioral intervention
expert system
stages of change
motivational interviewing
Self Care
Expert Systems
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases