Increasing Vitamin Intake and Physical Activity (BIV-BIA)
Primary Purpose
Heart Diseases, Diabetes Mellitus, Type 2, Behavior
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intervention Group (IG)
Sponsored by

About this trial
This is an interventional prevention trial for Heart Diseases focused on measuring Randomized Controlled Trial, evidence- and theory-based behavioral intervention, expert system, stages of change, motivational interviewing, tailoring, Self Care, Expert Systems
Eligibility Criteria
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
Sites / Locations
- Freie Universitaet Berlin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group (IG)
Waiting control group (WCG)
Arm Description
Employees in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of them
Outcomes
Primary Outcome Measures
health behavior (physical activity & fruits and vegetables)
Secondary Outcome Measures
subjective health
work satisfaction
motivation/volition
social-cognitive predictors of behavior (self-efficacy, action control etc.)
objective health measures (body mass index, cholesterol, blood glucose ect.)
perceived occupational efficiency
Full Information
NCT ID
NCT00985179
First Posted
September 24, 2009
Last Updated
November 12, 2012
Sponsor
Freie Universität Berlin
Collaborators
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT00985179
Brief Title
Increasing Vitamin Intake and Physical Activity
Acronym
BIV-BIA
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 Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Freie Universität Berlin
Collaborators
Boehringer Ingelheim
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Diabetes Mellitus, Type 2, Behavior, Motivation
Keywords
Randomized Controlled Trial, evidence- and theory-based behavioral intervention, expert system, stages of change, motivational interviewing, tailoring, Self Care, Expert Systems
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group (IG)
Arm Type
Experimental
Arm Description
Employees in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of them
Arm Title
Waiting control group (WCG)
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group (IG)
Other Intervention Name(s)
HAPA-based stage-matched intervention
Intervention Description
Employees in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of them
Primary Outcome Measure Information:
Title
health behavior (physical activity & fruits and vegetables)
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
subjective health
Time Frame
13 weeks
Title
work satisfaction
Time Frame
13 weeks
Title
motivation/volition
Time Frame
13 weeks
Title
social-cognitive predictors of behavior (self-efficacy, action control etc.)
Time Frame
13 weeks
Title
objective health measures (body mass index, cholesterol, blood glucose ect.)
Time Frame
13 weeks
Title
perceived occupational efficiency
Time Frame
13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Ernsting
Organizational Affiliation
Freie Universitaet Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Freie Universitaet Berlin
City
Berlin
ZIP/Postal Code
14195
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Increasing Vitamin Intake and Physical Activity
We'll reach out to this number within 24 hrs