Clinical trial NCT00985179: Increasing Vitamin Intake and Physical Activity
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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Freie Universität Berlin
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2009-09-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: health behavior (physical activity & fruits and vegetables)
timeFrame: 13 weeks
Secondary outcomes:
measure: subjective health
timeFrame: 13 weeks
measure: work satisfaction
timeFrame: 13 weeks
measure: motivation/volition
timeFrame: 13 weeks
measure: social-cognitive predictors of behavior (self-efficacy, action control etc.)
timeFrame: 13 weeks
measure: objective health measures (body mass index, cholesterol, blood glucose ect.)
timeFrame: 13 weeks
measure: perceived occupational efficiency
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Freie Universitaet Berlin
Study officials:
affiliation: Freie Universitaet Berlin
name: Anna Ernsting
role: PRINCIPAL_INVESTIGATOR
References: