An interventional study of Counseling letter in Blood Pressure, High and Cardiovascular Risk Factor, sponsored by University Medicine Greifswald. Completed at 1 site in Germany. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-11.
Sponsored by University Medicine Greifswald · Not applicable, Interventional, and Prevention
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.
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.
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Exclusion Criteria:
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
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.
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.
Systolic blood pressure
Reduction of 4 mmHg mean systolic blood pressure in intervention group; Measures: standardized measurements of mean systolic blood pressure (in mmHg)
Time frame: Change from baseline mean systolic blood pressure at 12 months
Waist and hip circumference
Reduction of waist and hip circumference in intervention group; Measures: standardized measurements of waist and hip circumference (in cm)
Time frame: Change from baseline waist and hip circumference at 12 months
Physical activity by self-report
Measures: assessement via tablet PC or phone calls (International Physical Activity Questionnaire, IPAQ)
Time frame: Change from baseline physical activity at 12 months
Physical activity by accelerometry (if data are available)
Measures: objective measurement of physical activity by accelerometry
Time frame: Change from baseline physical activity at 12 months
Sedentary time by self-report
Measures: assessement via tablet PC or phone calls (last 7-d sedentary behavior questionnaire, SIT-Q-7d)
Time frame: Change from baseline sedentary time at 12 months
Sedentary behavior by accelerometry (if data are available)
Measures: objective measurement of sedentary behavior by accelerometry
Time frame: Change from baseline physical inactivity at 12 months
Smoking by self-report
Measures: questions regarding smoking (assessment via tablet PC or phone calls)
Time frame: Change from baseline smoking at 12 months
Plan to share: Undecided
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