Heart DiseasesBIV-BIANCT00985179
Increasing Vitamin Intake and Physical Activity
A study testing Intervention Group (IG) in people with Heart Diseases and Diabetes Mellitus, Type 2, run by Freie Universität Berlin at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases, Diabetes Mellitus, Type 2, Behavior
- What is being tested?
- Intervention Group (IG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- no internet access
- no computer with keyboard
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Heart Diseases, Diabetes Mellitus, Type 2, Behavior, Motivation
- Being tested
- Intervention Group (IG)
- Keywords
- Randomized Controlled Trial, evidence- and theory-based behavioral intervention, expert system, stages of change, motivational interviewing, tailoring, Self Care, Expert Systems
- Medical subject headings
- Heart Diseases, Diabetes Mellitus, Type 2, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group (IG)Behavioural
Also called HAPA-based stage-matched intervention
Employees in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of them
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Intervention Group (IG) |
| Waiting control group (WCG) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
health behavior (physical activity & fruits and vegetables)
Measured: 13 weeks
Secondary outcomes (6)
subjective health
Measured: 13 weeks
work satisfaction
Measured: 13 weeks
motivation/volition
Measured: 13 weeks
social-cognitive predictors of behavior (self-efficacy, action control etc.)
Measured: 13 weeks
objective health measures (body mass index, cholesterol, blood glucose ect.)
Measured: 13 weeks
perceived occupational efficiency
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Freie Universität Berlin
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Investigators
- Anna Ernsting, Principal investigator, Freie Universitaet Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985179
- Sponsor's protocol ID
- FU-19-4711-008
- Other IDs
- BI Vit, BI Activ
- Acronym
- BIV-BIA
- Status last verified
- Jun 2011
- First submitted
- 24 Sep 2009
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00985179
- Acronym / sponsor ID
- BIV-BIA / FU-19-4711-008
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Freie Universität BerlinUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Oct 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 28 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IG) | Experimental | 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 |
| Waiting control group (WCG) | No intervention | – |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- no internet access
- no computer with keyboard
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Group (IG)Also: HAPA-based stage-matched interventionEmployees in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of them | Behavioural | Intervention Group (IG) |
Primary outcome
health behavior (physical activity & fruits and vegetables)
Time frame: 13 weeks
6 secondary outcomes
subjective health
Time frame: 13 weeks
work satisfaction
Time frame: 13 weeks
motivation/volition
Time frame: 13 weeks
social-cognitive predictors of behavior (self-efficacy, action control etc.)
Time frame: 13 weeks
objective health measures (body mass index, cholesterol, blood glucose ect.)
Time frame: 13 weeks
perceived occupational efficiency
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Ernsting principal investigator
Freie Universitaet Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group (IG) in people with Heart Diseases and Diabetes Mellitus, Type 2, run by Freie Universität Berlin at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health behavior (physical activity & fruits and vegetables) (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2012.