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

This study has been completed.
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01085890
First received: March 11, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Blood Pressure
Life Style
Behavioral: Motivational interviewing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hypertension in Primary Health Care: Can More Intensive Work With Lifestyle Change Help Patients Achieve Blood Pressure Goals?

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 6 months after conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lifestyle factors [ Time Frame: 6 months after conclusion of study ] [ Designated as safety issue: No ]
    Lifestyle factors included physical activity, stress, tobacco use, alohol habits, and diet.

  • Body mass index (BMI) [ Time Frame: 6 months after conclusion of study ] [ Designated as safety issue: No ]
    Body mass index = weight in kilograms/height in square meters

  • Abdominal circumference [ Time Frame: 6 months after conclusion of study ] [ Designated as safety issue: No ]
    Measurement in centimeters of the abdomen.


Enrollment: 141
Study Start Date: March 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085890

Locations
Sweden
Jordbro Primary Health Care Center
Haninge, Sweden, 213651
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Investigators
Principal Investigator: Lena Holm, MD, PhD Karolinska Institutet
  More Information

Publications:
Responsible Party: Lena Holm, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01085890     History of Changes
Other Study ID Numbers: KI 2006/1285-31, 511025-2672
Study First Received: March 11, 2010
Last Updated: March 11, 2010
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Blood Pressure
Life Style
Body Mass Index
Obesity, Abdominal
Blood Chemical Analysis

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014