LifestyleNCT02744157
Long Term Effects of a Structured Lifestyle Program
A study testing Longterm effects after a structured lifestyle program in people with Lifestyle and Quality of Life, run by Karolinska University Hospital.
Trial summary
The aim of the present study was to describe a structured intervention to reduce cardiovascular risk in a clinical setting and to study the effects of the program on lifestyle habits and quality of life in individuals at risk after six months and one year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lifestyle, Quality of Life
- What is being tested?
- Longterm effects after a structured lifestyle program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (three risk factors )
- cardiovascular disease
- physical inactivity
- smoking
- risk consumption of alcohol
- unhealthy food habits
Show all 11Show fewer
- stress
- overweight or abdominal obesity
- high lipids (cholesterol, LDL)
- high blood pressure
- diabetes/insulin resistance.
Who cannot join
- Not understand Swedish language
About this study
Official title: Long Term Effects on Lifestyle Habits and Quality of Life in Individuals With Increased Cardiometabolic Risk Participating in a Structured Lifestyle Intervention Program
The aim of the present study was to describe a structured intervention to reduce cardiovascular risk in a clinical setting and to study the effects of the program on lifestyle habits and quality of life in individuals at risk after six months and one year.
- Conditions
- Lifestyle, Quality of Life
- Being tested
- Longterm effects after a structured lifestyle program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longterm effects after a structured lifestyle programBehavioural
present study was to describe a structured intervention to reduce cardiovascular risk in a clinical setting and to study the effects of the program on lifestyle habits and quality of life in individuals at risk after six months and one year.
| Study group | Role | What they receive |
|---|---|---|
| structured lifestyle program | Other | The program consisted of an individual visit to a nurse for a health check-up and lifestyle counseling at baseline, six month and one year. The program also consisted of five group educations which included lectures on nicotine, alcohol, physical inactivity, eating habits, stress, sleeping habits and behavior changes Receives: Behavioral: Longterm effects after a structured lifestyle program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular risk
change from baseline in waist circumference after one year
Measured: change from baseline in waist circumference after one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startJan 2008
- Primary completionJan 2008
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LifestyleStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Mai-Lis Hellenius, Karolinska University Hospital
- Investigators
- Mai-Lis Hellenius, Professor, Principal investigator, Karolinska Institutet, Department of medicine and Karolinska University Hospital,Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744157
- Sponsor's protocol ID
- 2015/494-31/2
- Status last verified
- Apr 2016
- First submitted
- 3 Mar 2016
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Lidin M, Hellenius ML, Rydell-Karlsson M, Ekblom-Bak E. Long-term effects on cardiovascular risk of a structured multidisciplinary lifestyle program in clinical practice. BMC Cardiovasc Disord. 2018 Apr 2;18(1):59. doi: 10.1186/s12872-018-0792-6.
PubMed 29609555
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effects on Lifestyle Habits and Quality of Life in Individuals With Increased Cardiometabolic Risk Participating in a Structured Lifestyle Intervention Program
- ClinicalTrials.gov ID
- NCT02744157
- Acronym / sponsor ID
- 2015/494-31/2
- Conditions
- Lifestyle, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Jan 2008
- Primary completion
- Jan 2008 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Apr 2016 (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.
The aim of the present study was to describe a structured intervention to reduce cardiovascular risk in a clinical setting and to study the effects of the program on lifestyle habits and quality of life in individuals at risk after six months and one year.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| structured lifestyle program | Other | Behavioral: Longterm effects after a structured lifestyle programThe program consisted of an individual visit to a nurse for a health check-up and lifestyle counseling at baseline, six month and one year. The program also consisted of five group educations which included lectures on nicotine, alcohol, physical inactivity, eating habits, stress, sleeping habits and behavior changes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- (three risk factors )
- cardiovascular disease
- physical inactivity
- smoking
- risk consumption of alcohol
Key exclusion criteria (1 listed)
- Not understand Swedish language
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 |
|---|---|---|
| Longterm effects after a structured lifestyle programpresent study was to describe a structured intervention to reduce cardiovascular risk in a clinical setting and to study the effects of the program on lifestyle habits and quality of life in individuals at risk after six months and one year. | Behavioural | structured lifestyle program |
Primary outcome
Cardiovascular risk
Time frame: change from baseline in waist circumference after one year
change from baseline in waist circumference after one year
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 20 Apr 2016.
- Derived from this study: PubMed 29609555Lidin M, Hellenius ML, Rydell-Karlsson M, Ekblom-Bak E. Long-term effects on cardiovascular risk of a structured multidisciplinary lifestyle program in clinical practice. BMC Cardiovasc Disord. 2018 Apr 2;18(1):59. doi: 10.1186/s12872-018-0792-6.
- Individual participant dataSharing planned: Undecided
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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.
Mai-Lis Hellenius, Professor principal investigator
Karolinska Institutet, Department of medicine and Karolinska University Hospital,Department of Cardiology
Questions about this trial
What is this clinical trial studying?
A study testing Longterm effects after a structured lifestyle program in people with Lifestyle and Quality of Life, run by Karolinska University Hospital.
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 11 inclusion and 1 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 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Cardiovascular risk (time frame: change from baseline in waist circumference after one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02744157, which also lists 1 linked publication.
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 20 Apr 2016.