Increasing Vitamin Intake and Physical Activity (BIV-BIA)
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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 |
- health behavior (physical activity & fruits and vegetables) [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
- 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 |
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| Germany | |
| Freie Universitaet Berlin | |
| Berlin, Germany, 14195 | |
| 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Cardiovascular Diseases Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013