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Increasing Vitamin Intake and Physical Activity (BIV-BIA)

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Freie Universität Berlin
ClinicalTrials.gov Identifier:
NCT00985179
First received: September 24, 2009
Last updated: November 12, 2012
Last verified: June 2011
  Purpose

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 Intervention
Heart Diseases
Diabetes Mellitus, Type 2
Behavior
Motivation
Behavioral: Intervention Group (IG)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Freie Universität Berlin:

Primary Outcome Measures:
  • health behavior (physical activity & fruits and vegetables) [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • subjective health [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • work satisfaction [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • motivation/volition [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • social-cognitive predictors of behavior (self-efficacy, action control etc.) [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • objective health measures (body mass index, cholesterol, blood glucose ect.) [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • perceived occupational efficiency [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: October 2009
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985179

Locations
Germany
Freie Universitaet Berlin
Berlin, Germany, 14195
Sponsors and Collaborators
Freie Universität Berlin
Boehringer Ingelheim
Investigators
Principal Investigator: Anna Ernsting Freie Universitaet Berlin
  More Information

No publications provided

Responsible Party: Sonia Lippke, Dr.; Assistant Professor (C1), Freie Universität Berlin
ClinicalTrials.gov Identifier: NCT00985179     History of Changes
Other Study ID Numbers: FU-19-4711-008, BI Vit, BI Activ
Study First Received: September 24, 2009
Last Updated: November 12, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Freie Universität Berlin:
Randomized Controlled Trial
evidence- and theory-based behavioral intervention
expert system
stages of change
motivational interviewing
tailoring
Self Care
Expert Systems

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vitamins
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014