Increasing Vitamin Intake and Physical Activity (BIV-BIA)

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).

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Diabetes Mellitus, Type 2; Motivation; Behavior
• Intervention / Treatment: Behavioral: Intervention Group (IG)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14195
    • Freie Universitaet Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: HAPA-based stage-matched intervention
No Intervention: Waiting control group (WCG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
health behavior (physical activity & fruits and vegetables)	13 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
subjective health	13 weeks
work satisfaction	13 weeks
motivation/volition	13 weeks
social-cognitive predictors of behavior (self-efficacy, action control etc.)	13 weeks
objective health measures (body mass index, cholesterol, blood glucose ect.)	13 weeks
perceived occupational efficiency	13 weeks

Collaborators and Investigators

• Sponsor: Freie Universität Berlin
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Anna Ernsting, Freie Universitaet Berlin

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: September 24, 2009
• First Submitted That Met QC Criteria: September 25, 2009
• First Posted (Estimate): September 28, 2009

Study Record Updates

• Last Update Posted (Estimate): November 14, 2012
• Last Update Submitted That Met QC Criteria: November 12, 2012
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; motivational interviewing; evidence- and theory-based behavioral intervention; expert system; stages of change; tailoring; Self Care; Expert Systems
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Heart Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: FU-19-4711-008; BI Vit; BI Activ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No