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Increasing Vitamin Intake and Physical Activity

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00985179
Acronym
BIV-BIA
Enrollment
1000
Registered
2009-09-28
Start date
2009-10-31
Completion date
2012-03-31
Last updated
2012-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Randomized Controlled Trial, evidence- and theory-based behavioral intervention, expert system, stages of change, motivational interviewing, tailoring, Self Care, Expert Systems

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.

Interventions

Employees in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of them

Sponsors

Boehringer Ingelheim
CollaboratorINDUSTRY
Freie Universität Berlin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
health behavior (physical activity & fruits and vegetables)13 weeks

Secondary

MeasureTime frame
work satisfaction13 weeks
motivation/volition13 weeks
subjective health13 weeks
objective health measures (body mass index, cholesterol, blood glucose ect.)13 weeks
perceived occupational efficiency13 weeks
social-cognitive predictors of behavior (self-efficacy, action control etc.)13 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026