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

March 11, 2010 updated by: Karolinska Institutet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

141

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Haninge, Sweden, 213651
        • Jordbro Primary Health Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Motivational interviewing group
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.
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.
NO_INTERVENTION: Treatment as usual
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: 6 months after conclusion of study
6 months after conclusion of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lifestyle factors
Time Frame: 6 months after conclusion of study
Lifestyle factors included physical activity, stress, tobacco use, alohol habits, and diet.
6 months after conclusion of study
Body mass index (BMI)
Time Frame: 6 months after conclusion of study
Body mass index = weight in kilograms/height in square meters
6 months after conclusion of study
Abdominal circumference
Time Frame: 6 months after conclusion of study
Measurement in centimeters of the abdomen.
6 months after conclusion of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

Investigators

  • Principal Investigator: Lena Holm, MD, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

March 11, 2010

First Posted (ESTIMATE)

March 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 12, 2010

Last Update Submitted That Met QC Criteria

March 11, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KI 2006/1285-31
  • 511025-2672 (OTHER_GRANT: Stockholm County Council)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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