Hypertension in Primary Health Care: Lifestyle Change and Blood Pressure Goals

Blood Pressure Clinical Trial

Official title:

Hypertension in Primary Health Care: Can More Intensive Work With Lifestyle Change Help Patients Achieve Blood Pressure Goals?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085890
• Other study ID #: KI 2006/1285-31
• Secondary ID: 511025-2672
• Status: Completed
• Phase: N/A
• First received: March 11, 2010
• Last updated: March 11, 2010
• Start date: March 2007
• Est. completion date: November 2008

Study information

• Verified date: March 2010
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Pressure
• Life Style

Intervention

Behavioral:
• Motivational interviewing
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.

Locations

Country	Name	City	State
Sweden	Jordbro Primary Health Care Center	Haninge

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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. — View 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. Epub 2003 Jul 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure		6 months after conclusion of study	No
Secondary	Lifestyle factors	Lifestyle factors included physical activity, stress, tobacco use, alohol habits, and diet.	6 months after conclusion of study	No
Secondary	Body mass index (BMI)	Body mass index = weight in kilograms/height in square meters	6 months after conclusion of study	No
Secondary	Abdominal circumference	Measurement in centimeters of the abdomen.	6 months after conclusion of study	No