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Completed

NCT Number: NCT03077373

Efficacy of a Brief Intervention on Reduction of Systolic Blood Pressure

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Social Medicine and Prevention, University Medicine Greifswald

Greifswald, 17475, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Systolic blood pressure

    Time frame: Change from baseline mean systolic blood pressure at 12 months

    Reduction of 4 mmHg mean systolic blood pressure in intervention group; Measures: standardized measurements of mean systolic blood pressure (in mmHg)

Secondary outcomes

  1. Waist and hip circumference

    Time frame: Change from baseline waist and hip circumference at 12 months

    Reduction of waist and hip circumference in intervention group; Measures: standardized measurements of waist and hip circumference (in cm)

  2. Physical activity by self-report

    Time frame: Change from baseline physical activity at 12 months

    Measures: assessement via tablet PC or phone calls (International Physical Activity Questionnaire, IPAQ)

  3. Physical activity by accelerometry (if data are available)

    Time frame: Change from baseline physical activity at 12 months

    Measures: objective measurement of physical activity by accelerometry

  4. Sedentary time by self-report

    Time frame: Change from baseline sedentary time at 12 months

    Measures: assessement via tablet PC or phone calls (last 7-d sedentary behavior questionnaire, SIT-Q-7d)

  5. Sedentary behavior by accelerometry (if data are available)

    Time frame: Change from baseline physical inactivity at 12 months

    Measures: objective measurement of sedentary behavior by accelerometry

  6. Smoking by self-report

    Time frame: Change from baseline smoking at 12 months

    Measures: questions regarding smoking (assessment via tablet PC or phone calls)

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2017
Registry last updated
Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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