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

March 11, 2010
March 11, 2010
March 2007
November 2008   (final data collection date for primary outcome measure)
Blood pressure [ Time Frame: 6 months after conclusion of study ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
Hypertension in Primary Health Care: Lifestyle Change and Blood Pressure Goals
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Blood Pressure
  • Life Style
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.
  • 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.
    Intervention: Behavioral: Motivational interviewing
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01085890
KI 2006/1285-31, 511025-2672
No
Lena Holm, Karolinska Institutet
Karolinska Institutet
Stockholm County Council, Sweden
Principal Investigator: Lena Holm, MD, PhD Karolinska Institutet
Karolinska Institutet
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP