HypertensionPhase 3NCT00486941
Lifestyle Intervention in Primary Health Care - the Björknäs Study
A Phase 3 study testing Exercise and diet - based on DPS and DPP in people with Hypertension and Type 2 Diabetes, run by Umeå University at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether a short group intervention programe aiming at lifestyle changes at a local health centre can improve risk factors for cardiovascular disease Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Type 2 Diabetes, Obesity
- What is being tested?
- Exercise and diet - based on DPS and DPP
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 151 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2003to Mar 2006
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from one single health care centre with a diagnosis of:
- Typ 2 diabetes,
- Hypertension,
- Obesity or
- Dyslipidemia
Who cannot join
- Coronary heart
- Disease,
- Stroke,
- TIA,
- BP >180/105,
- Dementia; or
- Severe psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Lifestyle Intervention in Primary Health Care for the Modification of Cardiovascular Risk Factors - the Björknäs Study
The purpose of this study is to determine whether a short group intervention programe aiming at lifestyle changes at a local health centre can improve risk factors for cardiovascular disease
Read the detailed description
Successfully transferring the findings of expensive and tightly controlled lifestyle intervention programmes to the primary care setting is necessary if such knowledge is to be used for disease prevention at the population level. Therefore, our objective was to evaluate the efficacy of a lifestyle intervention programe in the primary health care setting, targeted at patients with moderate- to high-risk of cardiovascular disease according to cardiovascular risk factor levels, physical activity and quality of life ratings.
Randomised controlled trial with follow-up at 3, 12, 24 and 36 months, carried out in a primary health care centre in Northern Sweden. A total of 151 middle-aged men and women, with hypertension, dyslipidemia, type 2 diabetes or obesity were enrolled. The subjects were randomised to an intervention (n = 75) or control group (n = 76). 120 subjects completed the three-year follow-up. The intervention was based on the protocols used in the Finnish Diabetes Prevention study (DPS) and the U.S Diabetes Prevention Program
- Conditions
- Hypertension, Type 2 Diabetes, Obesity, Dyslipidemia
- Being tested
- Exercise and diet - based on DPS and DPP
- Keywords
- Primary Prevention, Health Promotion, Diet, Exercise, Risk Factors, Randomized Controlled Trial
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Obesity, Dyslipidemias, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and diet - based on DPS and DPPBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in anthropometry (BMI, waist and hip cf)
Measured: 3 years
Maximal oxygen uptake (VO2max)
Measured: 3 years
Health-related quality of life (EQ 5D, SF-36)
Measured: 3 years
Self-reported physical activity
Measured: 3 years
Secondary outcomes (3)
Blood pressure
Measured: 3 years
Total cholesterol, HDL and triglycerides
Measured: 3 years
Glucose tolerance (OGTT)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2007 (estimated)
- Study startFeb 2003
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- County Council of Norrbotten, Sweden
- Investigators
- Mats CE Eliasson, MD, PhD, Principal investigator, Umeå University, Umeå, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486941
- Sponsor's protocol ID
- EPN-Umea 02-512
- Status last verified
- Jul 2007
- First submitted
- 14 Jun 2007
- Last updated
- 20 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Eriksson KM, Westborg CJ, Eliasson MC. A randomized trial of lifestyle intervention in primary healthcare for the modification of cardiovascular risk factors. Scand J Public Health. 2006;34(5):453-61. doi: 10.1080/14034940500489826.
PubMed 16990155Eriksson MK, Hagberg L, Lindholm L, Malmgren-Olsson EB, Osterlind J, Eliasson M. Quality of life and cost-effectiveness of a 3-year trial of lifestyle intervention in primary health care. Arch Intern Med. 2010 Sep 13;170(16):1470-9. doi: 10.1001/archinternmed.2010.301.
PubMed 20837834Eriksson MK, Franks PW, Eliasson M. A 3-year randomized trial of lifestyle intervention for cardiovascular risk reduction in the primary care setting: the Swedish Bjorknas study. PLoS One. 2009;4(4):e5195. doi: 10.1371/journal.pone.0005195. Epub 2009 Apr 14.
PubMed 19365563
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Lifestyle Intervention in Primary Health Care for the Modification of Cardiovascular Risk Factors - the Björknäs Study
- ClinicalTrials.gov ID
- NCT00486941
- Acronym / sponsor ID
- EPN-Umea 02-512
- Conditions
- Hypertension, Type 2 Diabetes, Obesity, Dyslipidemia
- Keywords
- Primary Prevention, Health Promotion, Diet, Exercise, Risk Factors, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- County Council of Norrbotten, Sweden
- Study start
- Feb 2003
- Study completion
- Mar 2006 (actual)
- First posted
- 15 Jun 2007 (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 purpose of this study is to determine whether a short group intervention programe aiming at lifestyle changes at a local health centre can improve risk factors for cardiovascular disease
Detailed description
Successfully transferring the findings of expensive and tightly controlled lifestyle intervention programmes to the primary care setting is necessary if such knowledge is to be used for disease prevention at the population level. Therefore, our objective was to evaluate the efficacy of a lifestyle intervention programe in the primary health care setting, targeted at patients with moderate- to high-risk of cardiovascular disease according to cardiovascular risk factor levels, physical activity and quality of life ratings.
Randomised controlled trial with follow-up at 3, 12, 24 and 36 months, carried out in a primary health care centre in Northern Sweden. A total of 151 middle-aged men and women, with hypertension, dyslipidemia, type 2 diabetes or obesity were enrolled. The subjects were randomised to an intervention (n = 75) or control group (n = 76). 120 subjects completed the three-year follow-up. The intervention was based on the protocols used in the Finnish Diabetes Prevention study (DPS) and the U.S Diabetes Prevention Program
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients from one single health care centre with a diagnosis of:
Key exclusion criteria (7 listed)
- Coronary heart
- Disease,
- Stroke,
- TIA,
- BP >180/105,
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 |
|---|---|---|
| Exercise and diet - based on DPS and DPP | Behavioural | – |
Primary outcome
Changes in anthropometry (BMI, waist and hip cf)
Time frame: 3 years
Maximal oxygen uptake (VO2max)
Time frame: 3 years
Health-related quality of life (EQ 5D, SF-36)
Time frame: 3 years
Self-reported physical activity
Time frame: 3 years
3 secondary outcomes
Blood pressure
Time frame: 3 years
Total cholesterol, HDL and triglycerides
Time frame: 3 years
Glucose tolerance (OGTT)
Time frame: 3 years
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 Jul 2007.
- Results publication: PubMed 16990155Eriksson KM, Westborg CJ, Eliasson MC. A randomized trial of lifestyle intervention in primary healthcare for the modification of cardiovascular risk factors. Scand J Public Health. 2006;34(5):453-61. doi: 10.1080/14034940500489826.
- Derived from this study: PubMed 20837834Eriksson MK, Hagberg L, Lindholm L, Malmgren-Olsson EB, Osterlind J, Eliasson M. Quality of life and cost-effectiveness of a 3-year trial of lifestyle intervention in primary health care. Arch Intern Med. 2010 Sep 13;170(16):1470-9. doi: 10.1001/archinternmed.2010.301.
- Derived from this study: PubMed 19365563Eriksson MK, Franks PW, Eliasson M. A 3-year randomized trial of lifestyle intervention for cardiovascular risk reduction in the primary care setting: the Swedish Bjorknas study. PLoS One. 2009;4(4):e5195. doi: 10.1371/journal.pone.0005195. Epub 2009 Apr 14.
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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.
Mats CE Eliasson, MD, PhD principal investigator
Umeå University, Umeå, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise and diet - based on DPS and DPP in people with Hypertension and Type 2 Diabetes, run by Umeå University at 1 site in Sweden.
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 5 inclusion and 7 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 Jul 2007. 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 Sweden. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in anthropometry (BMI, waist and hip cf) (time frame: 3 years). The study lists 4 primary outcomes in all. 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 NCT00486941, which also lists 3 linked publications.
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 Jul 2007.