Blood PressureNCT01085890
Hypertension in Primary Health Care: Lifestyle Change and Blood Pressure Goals
A study testing Motivational interviewing in people with Blood Pressure and Life Style, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether a program that includes 1) group seminars and 2) follow-up visits with blood pressure measurement and motivational interviewing (MI) that is focused on lifestyle change affect blood pressure. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Blood Pressure, Life Style
- What is being tested?
- Motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2007to Nov 2008
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- => 30 years
- ability to speak Swedish well enough to fill the baseline and follow-up questionnaires, participate in the seminars, and participate in the motivational interviewing
Who cannot join
- < 30 years
- inability to speak Swedish well enough to fill the baseline and follow-up questionnaires, participate in the seminars, and participate in the motivational interviewing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypertension in Primary Health Care: Can More Intensive Work With Lifestyle Change Help Patients Achieve Blood Pressure Goals?
The purpose of this study is to determine whether a program that includes 1) group seminars and 2) follow-up visits with blood pressure measurement and motivational interviewing (MI) that is focused on lifestyle change affect blood pressure.
Read the detailed description
High blood pressure is common in the population. In an earlier study conducted in our local geographical area, "How is health in Jordbro?" 46% of participants had a systolic blood pressure of >140 millimeters of mercury (mm Hg) and 22% had a diastolic blood pressure >90 mm Hg. 84% of those with known hypertension had a systolic blood pressure of >140. We thus found that many people in our area have heightened blood pressure, and hypothesized that many of these people, particularly those with mild hypertension, probably could be helped with lifestyle-related intervention.
All persons who came to Jordbro Primary Health Care Center during a 6-month period were invited to participate in the current study, and local press announcements were used to recruit additional participants. A total of 301 persons volunteered to participate. A total of 141 of the volunteers had a systolic blood pressure =>140 and/or a diastolic blood pressure of =>90, and these people became the study population. The 141 persons in the study population filled in a questionnaire with general background and lifestyle questions.
Of the 141 persons in the study population, 75 had previously known hypertension and 66 had hypertension that was previously unknown. Participants were then randomized such that an equal number of persons with previously known and previously unknown hypertension were included in a) a treatment group and b) a control group. Background information such as height, weight, pulse, smoking habits, other diseases, and prescription drugs was gathered. Blood sugar and lipid tests were conducted. Participants' family physician were contacted as necessary (e.g., if blood pressure was dangerously high).
The intervention consisted of 2 group seminars with information on hypertension and related lifestyle factors and 2 follow-up visits with each participant in which blood pressure was measured and motivational interviewing took place. The motivational interviewing focused on lifestyle factors, including physical activity, stress, tobacco use, alcohol habits, and diet. After 6 months, a follow-up was done that included blood pressure measurement and completion of the same questionnaire that was filled in at baseline.
- Conditions
- Blood Pressure, Life Style
- Being tested
- Motivational interviewing
- Keywords
- Blood Pressure, Life Style, Body Mass Index, Obesity, Abdominal, Blood Chemical Analysis
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
The intervention consisted of 2 group seminars with information on hypertension and related lifestyle factors and 2 follow-up visits in which blood pressure was measured and motivational interviewing took place. The motivational interviewing focused on lifestyle factors, including physical activity, stress, tobacco use, alcohol habits, and diet.
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviewing group | Experimental | The participants in this arm had 2 group seminars with information on hypertension and related lifestyle factors. They participated in 2 follow-up visits in which blood pressure was measured and motivational interviewing took place. The motivational interviewing focused on lifestyle factors, including physical activity, stress, tobacco use, alcohol habits, and diet. Receives: Behavioral: Motivational interviewing |
| Treatment as usual | No intervention | Participants in this group received treatment as usual for their high blood pressure, but no informational seminars and no extra visits with motivational interviewing and blood pressure measurement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: 6 months after conclusion of study
Secondary outcomes (3)
Lifestyle factors
Lifestyle factors included physical activity, stress, tobacco use, alohol habits, and diet.
Measured: 6 months after conclusion of study
Body mass index (BMI)
Body mass index = weight in kilograms/height in square meters
Measured: 6 months after conclusion of study
Abdominal circumference
Measurement in centimeters of the abdomen.
Measured: 6 months after conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startMar 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Investigators
- Lena Holm, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085890
- Sponsor's protocol ID
- KI 2006/1285-31
- Other IDs
- 511025-2672
- Status last verified
- Mar 2010
- First submitted
- 11 Mar 2010
- Last updated
- 12 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Al-Windi A. Detection and treatment of hypertension in general health-care practice: a patient-based study. J Hum Hypertens. 2005 Oct;19(10):775-86. doi: 10.1038/sj.jhh.1001902.
PubMed 15988540Al-Windi A. The validity of a questionnaire on medicines used in health care practice: comparison of a questionnaire and computerized medical record survey. Eur J Clin Pharmacol. 2003 Aug;59(4):321-9. doi: 10.1007/s00228-003-0615-1. Epub 2003 Jul 4.
PubMed 12845507
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension in Primary Health Care: Can More Intensive Work With Lifestyle Change Help Patients Achieve Blood Pressure Goals?
- ClinicalTrials.gov ID
- NCT01085890
- Acronym / sponsor ID
- KI 2006/1285-31
- Conditions
- Blood Pressure, Life Style
- Keywords
- Blood Pressure, Life Style, Body Mass Index, Obesity, Abdominal, Blood Chemical Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Mar 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 12 Mar 2010 (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 program that includes 1) group seminars and 2) follow-up visits with blood pressure measurement and motivational interviewing (MI) that is focused on lifestyle change affect blood pressure.
Detailed description
High blood pressure is common in the population. In an earlier study conducted in our local geographical area, "How is health in Jordbro?" 46% of participants had a systolic blood pressure of >140 millimeters of mercury (mm Hg) and 22% had a diastolic blood pressure >90 mm Hg. 84% of those with known hypertension had a systolic blood pressure of >140. We thus found that many people in our area have heightened blood pressure, and hypothesized that many of these people, particularly those with mild hypertension, probably could be helped with lifestyle-related intervention.
All persons who came to Jordbro Primary Health Care Center during a 6-month period were invited to participate in the current study, and local press announcements were used to recruit additional participants. A total of 301 persons volunteered to participate. A total of 141 of the volunteers had a systolic blood pressure =>140 and/or a diastolic blood pressure of =>90, and these people became the study population. The 141 persons in the study population filled in a questionnaire with general background and lifestyle questions.
Of the 141 persons in the study population, 75 had previously known hypertension and 66 had hypertension that was previously unknown. Participants were then randomized such that an equal number of persons with previously known and previously unknown hypertension were included in a) a treatment group and b) a control group. Background information such as height, weight, pulse, smoking habits, other diseases, and prescription drugs was gathered. Blood sugar and lipid tests were conducted. Participants' family physician were contacted as necessary (e.g., if blood pressure was dangerously high).
The intervention consisted of 2 group seminars with information on hypertension and related lifestyle factors and 2 follow-up visits with each participant in which blood pressure was measured and motivational interviewing took place. The motivational interviewing focused on lifestyle factors, including physical activity, stress, tobacco use, alcohol habits, and diet. After 6 months, a follow-up was done that included blood pressure measurement and completion of the same questionnaire that was filled in at baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing group | Experimental | Behavioral: Motivational interviewingThe participants in this arm had 2 group seminars with information on hypertension and related lifestyle factors. They participated in 2 follow-up visits in which blood pressure was measured and motivational interviewing took place. The motivational interviewing focused on lifestyle factors, including physical activity, stress, tobacco use, alcohol habits, and diet. |
| Treatment as usual | No intervention | –Participants in this group received treatment as usual for their high blood pressure, but no informational seminars and no extra visits with motivational interviewing and blood pressure measurement. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- => 30 years
- ability to speak Swedish well enough to fill the baseline and follow-up questionnaires, participate in the seminars, and participate in the motivational interviewing
Key exclusion criteria (2 listed)
- < 30 years
- inability to speak Swedish well enough to fill the baseline and follow-up questionnaires, participate in the seminars, and participate in the motivational interviewing
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 |
|---|---|---|
| Motivational interviewingThe intervention consisted of 2 group seminars with information on hypertension and related lifestyle factors and 2 follow-up visits in which blood pressure was measured and motivational interviewing took place. The motivational interviewing focused on lifestyle factors, including physical activity, stress, tobacco use, alcohol habits, and diet. | Behavioural | Motivational interviewing group |
Primary outcome
Blood pressure
Time frame: 6 months after conclusion of study
3 secondary outcomes
Lifestyle factors
Time frame: 6 months after conclusion of study
Body mass index (BMI)
Time frame: 6 months after conclusion of study
Abdominal circumference
Time frame: 6 months after conclusion of study
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 12 Mar 2010.
- Background: PubMed 15988540Al-Windi A. Detection and treatment of hypertension in general health-care practice: a patient-based study. J Hum Hypertens. 2005 Oct;19(10):775-86. doi: 10.1038/sj.jhh.1001902.
- Background: PubMed 12845507Al-Windi A. The validity of a questionnaire on medicines used in health care practice: comparison of a questionnaire and computerized medical record survey. Eur J Clin Pharmacol. 2003 Aug;59(4):321-9. doi: 10.1007/s00228-003-0615-1. Epub 2003 Jul 4.
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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.
Lena Holm, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing in people with Blood Pressure and Life Style, run by Karolinska Institutet 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 2 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 12 Mar 2010. 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.
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?
Blood pressure (time frame: 6 months after conclusion of study). 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 NCT01085890, which also lists 2 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 12 Mar 2010.