Increasing Vitamin Intake and Physical Activity

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Behavioral: Intervention Group (IG)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group (IG)<br>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)<br>* Employees in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of them<br>* Other names: HAPA-based stage-matched intervention;|
| No Intervention: Waiting control group (WCG)<br> | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trial, evidence- and theory-based behavioral intervention, expert system, stages of change, motivational interviewing, tailoring, Self Care, Expert Systems