NCT01085890

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2010

Completed
Last Updated

March 12, 2010

Status Verified

March 1, 2010

Enrollment Period

1.7 years

First QC Date

March 11, 2010

Last Update Submit

March 11, 2010

Conditions

Blood PressureLife Style

Keywords

Blood PressureLife StyleBody Mass IndexObesity, AbdominalBlood Chemical Analysis

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    6 months after conclusion of study

Secondary Outcomes (3)

  • Lifestyle factors

    6 months after conclusion of study

  • Body mass index (BMI)

    6 months after conclusion of study

  • Abdominal circumference

    6 months after conclusion of study

Study Arms (2)

Motivational interviewing group

EXPERIMENTAL

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

Treatment as usual

NO INTERVENTION

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.

Interventions

Motivational interviewingBEHAVIORAL

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.

Motivational interviewing group

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • =\> 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

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordbro Primary Health Care Center

Haninge, 213651, Sweden

Location

Related 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. doi: 10.1038/sj.jhh.1001902.

    PMID: 15988540BACKGROUND

  • 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.

    PMID: 12845507BACKGROUND

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lena Holm, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2010

First Posted

March 12, 2010

Study Start

March 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

March 12, 2010

Record last verified: 2010-03

Locations

SE(1)