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Increasing Vitamin Intake and Physical Activity (BIV-BIA)

F

Freie Universität Berlin

Status

Completed

Conditions

Motivation
Behavior
Diabetes Mellitus, Type 2
Heart Diseases

Treatments

Behavioral: Intervention Group (IG)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00985179
FU-19-4711-008
BI Vit
BI Activ

Details and patient eligibility

About

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).

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,000 participants in 2 patient groups

Intervention Group (IG)
Experimental group
Description:
Employees in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of them
Treatment:
Behavioral: Intervention Group (IG)
Waiting control group (WCG)
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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