Diabetes Mellitus, Type 2 Clinical Trial
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
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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