Trials Sponsors Conditions Drugs Pricing

Conditions

Blood Pressure, High Cardiovascular Risk Factor

Keywords

systolic blood pressurephysical activitysedentary timesmoking

Outcome Measures

Primary Outcomes (1)

Systolic blood pressure
Reduction of 4 mmHg mean systolic blood pressure in intervention group; Measures: standardized measurements of mean systolic blood pressure (in mmHg)
Change from baseline mean systolic blood pressure at 12 months

Secondary Outcomes (6)

Waist and hip circumference
Change from baseline waist and hip circumference at 12 months
Physical activity by self-report
Change from baseline physical activity at 12 months
Physical activity by accelerometry (if data are available)
Change from baseline physical activity at 12 months
Sedentary time by self-report
Change from baseline sedentary time at 12 months
Sedentary behavior by accelerometry (if data are available)
Change from baseline physical inactivity at 12 months
+1 more secondary outcomes

Study Arms (2)

Counseling letter (intervention group)

EXPERIMENTAL

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.

Behavioral: Counseling letter

No counseling letter (control group)

NO INTERVENTION

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.

Interventions

Counseling letterBehavioral

The brief counseling letter intervention aiming to reduce physical inactivity, sedentary time in leisure time as well as smoking is based on behavior change theories (Transtheoretical model of health behavior change and Health Action Process Approach). The computerized intervention system includes up to six interactions with participants. 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.

Counseling letter (intervention group)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Othercollaborator
University Medicine Greifswald
Otherlead

Study Sites (1)

Institute of Social Medicine and Prevention, University Medicine Greifswald

Greifswald, 17475, Germany

MeSH Terms

Conditions

HypertensionMotor ActivitySedentary BehaviorSmoking

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Study Officials

Sabina Ulbricht, Dr.
Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany
STUDY CHAIR

Enrollment

106 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 10, 2017

Study Start

January 16, 2017

Actual (reported)

Efficacy of a Brief Intervention on Reduction of Systolic Blood Pressure

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Counseling letter (intervention group)

No counseling letter (control group)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Counseling letter (intervention group)

No counseling letter (control group)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations