Increasing Vitamin Intake and Physical Activity

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985179
• Other study ID #: FU-19-4711-008
• Secondary ID: BI VitBI Activ
• Status: Completed
• Phase: N/A
• First received: September 24, 2009
• Last updated: November 12, 2012
• Start date: October 2009
• Est. completion date: March 2012

Study information

• Verified date: June 2011
• Source: Freie Universität Berlin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Behavior
• Diabetes Mellitus, Type 2
• Heart Diseases
• Motivation

Intervention

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

Locations

Country	Name	City	State
Germany	Freie Universitaet Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Freie Universität Berlin	Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	health behavior (physical activity & fruits and vegetables)		13 weeks	Yes
Secondary	subjective health		13 weeks	Yes
Secondary	work satisfaction		13 weeks	Yes
Secondary	motivation/volition		13 weeks	Yes
Secondary	social-cognitive predictors of behavior (self-efficacy, action control etc.)		13 weeks	Yes
Secondary	objective health measures (body mass index, cholesterol, blood glucose ect.)		13 weeks	Yes
Secondary	perceived occupational efficiency		13 weeks	Yes