Efficacy of a Brief Intervention on Reduction of Systolic Blood Pressure

NCT03077373 | Completed

• 1 other identifier: BB005/17
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure, High; Cardiovascular Risk Factor

Keywords

systolic blood pressure; physical activity; sedentary time; smoking

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

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 letter BEHAVIORAL

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)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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:

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

Sponsors & Collaborators

• University Medicine Greifswald: lead
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK): collaborator

Study Sites (1)

Institute of Social Medicine and Prevention, University Medicine Greifswald

Greifswald, 17475, Germany

Location

MeSH Terms

Conditions

Hypertension; Motor Activity; Sedentary Behavior; Smoking

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Sabina Ulbricht, Dr.

  Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany

  STUDY CHAIR

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
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

DE (1)