Increasing Vitamin Intake and Physical Activity | NCT00985179

Studies
Increasing Vitamin Intake and Physical Activity

NCT00985179

Sponsor

Freie Universität Berlin

Status

Completed

Last Update Posted

Nov 14, 2012Estimated

Enrollment

1,000Estimated

Phase

Not Applicable

Conditions

Heart Diseases
Diabetes Mellitus, Type 2
Behavior
Motivation

Interventions

Intervention Group (IG)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Jan 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Sep 24, 2009

First Submission Date that Met QC Criteria

Sep 25, 2009

First Posted Date

Sep 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2012

Last Update Posted Date

Nov 14, 2012Estimated

Name	Class
Boehringer Ingelheim	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Group (IG)	Experimental	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)
Waiting control group (WCG)	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intervention Group (IG)	Behavioral	Employees in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of them

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
subjective health		13 weeks
work satisfaction		13 weeks
motivation/volition

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anna Ernsting	Freie Universitaet Berlin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Freie Universitaet Berlin		Berlin	State of Berlin	14195	Germany

Condition Browse Module

MeSH Terms

ID	Term
D006331	Heart Diseases
D003924	Diabetes Mellitus, Type 2
D001519	Behavior

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
BI Vit
BI Activ