Clinical trial NCT01085890: Hypertension in Primary Health Care: Lifestyle Change and Blood Pressure Goals
Official title: Hypertension in Primary Health Care: Can More Intensive Work With Lifestyle Change Help Patients Achieve Blood Pressure Goals?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Life Style
Keywords: Blood Pressure
Life Style
Body Mass Index
Obesity, Abdominal
Blood Chemical Analysis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2010-03-12
Enrollment: 141
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* =\> 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

Exclusion Criteria:

* \< 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

Primary outcomes:
measure: Blood pressure
timeFrame: 6 months after conclusion of study
Secondary outcomes:
measure: Lifestyle factors
timeFrame: 6 months after conclusion of study
measure: Body mass index (BMI)
timeFrame: 6 months after conclusion of study
measure: Abdominal circumference
timeFrame: 6 months after conclusion of study
Other outcomes:
Locations:
city: Haninge
country: Sweden
facility: Jordbro Primary Health Care Center
Study officials:
affiliation: Karolinska Institutet
name: Lena Holm, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Al-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.