Clinical trial NCT03077373: Efficacy of a Brief Intervention on Reduction of Systolic Blood Pressure
Official title: The Efficacy of a Computerized Brief Intervention Targeting Physical Activity, Sedentary Behavior, and Smoking Cessation on the Reduction of Systolic Blood Pressure in Individuals Aged 40 to 65 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure, High
Cardiovascular Risk Factor
Keywords: systolic blood pressure
physical activity
sedentary time
smoking
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2017-03-10
Enrollment: 106
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study examines the efficacy of individualized counseling letters to reduce systolic blood pressure level of ≥ 130 mmHg in individuals aged between 40 and 65 years. The computer-generated counseling letter intervention aimed to increase moderate-to-vigorous physical activity, to reduce sedentary time, and to achieve smoking abstinence.

Detailed description: This study examines the efficacy of individualized counseling letters to reduce systolic blood pressure level of ≥ 130 mmHg in individuals aged between 40 and 65 years. The computer-generated counseling letter intervention aimed to increase moderate-to-vigorous physical activity, to reduce sedentary time, and to achieve smoking abstinence. Participants are recruited by nurses in routine care of primary medical practices.

Informed consent consists of: (i) participation in standardized measurement of blood pressure as well as waist and hip circumference at baseline and 12-month follow up, (ii) completion of standardized questionnaires at 4 time points (baseline, 4-month, 7-month, and 12-month follow-up). Participation in accelerometry was defined as an option. Individuals who agree to wear the accelerometer do this for 10 days at baseline and 12-month follow-up, each.

After baseline assessment, individuals are randomly allocated to a control and to an intervention group (ratio 1:1).

Intervention: The computerized intervention system includes three interactions with participants aiming to increase moderate-to-vigorous physical activity and to reduce sedentary time. For individuals who were daily smokers at baseline, the computerized intervention system includes three more interactions with participants aiming to foster the motivation to quit smoking. Recurrent assessments are initiated by the system and provide data for scheduling the proceeding intervention steps and selection of relevant content. Physical activity, sedentary time, smoking, and motivational measures to change or maintain behaviors according to the recommendations will be monitored over time and used to provide feedback in the form of letters.

Intervention group: Individuals in this group complete a tablet PC-supported assessment at baseline and 12-month follow-up, both at the general practice. At months 4 and 7, follow-up data are collected by study team members via phone call. According to the assessments (baseline, month 4, and month 7), participants receive three counseling letters aiming to increase moderate-to-vigorous physical activity and to reduce sedentary time. Additionally, individuals who were daily smokers at baseline, receive three counseling letters aiming to foster the motivation to quit smoking. The first letter is accompanied by a self-help manual covering specific information relevant for the particular stage of motivation to change smoking behavior according to the principles of the Transtheoretical Model of behavior change.

Control group: Individuals in this group complete a tablet PC-supported assessment at baseline and 12-month follow-up, both in the general practice. At months 4 and 7, follow-up data are collected by study team members via phone call.

Eligibility criteria: Inclusion Criteria:

* men and women aged between 40 and 65 years
* mean systolic blood pressure ≥ 130 mmHg at baseline

Exclusion Criteria:

* cardiovascular event (myocardial infarction, stroke)
* vascular intervention
* cognitive impairment
* inadequate language skills
* severe disease with reduced life expectancy (\< 2 years)

Primary outcomes:
measure: Systolic blood pressure
timeFrame: Change from baseline mean systolic blood pressure at 12 months
Secondary outcomes:
measure: Waist and hip circumference
timeFrame: Change from baseline waist and hip circumference at 12 months
measure: Physical activity by self-report
timeFrame: Change from baseline physical activity at 12 months
measure: Physical activity by accelerometry (if data are available)
timeFrame: Change from baseline physical activity at 12 months
measure: Sedentary time by self-report
timeFrame: Change from baseline sedentary time at 12 months
measure: Sedentary behavior by accelerometry (if data are available)
timeFrame: Change from baseline physical inactivity at 12 months
measure: Smoking by self-report
timeFrame: Change from baseline smoking at 12 months
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Institute of Social Medicine and Prevention, University Medicine Greifswald
Study officials:
affiliation: Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany
name: Sabina Ulbricht, Dr.
role: STUDY_CHAIR
References: