- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03077373
Efficacy of a Brief Intervention on Reduction of Systolic Blood Pressure
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Greifswald, Tyskland, 17475
- Institute of Social Medicine and Prevention, University Medicine Greifswald
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Counseling letter (intervention group)
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.
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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. |
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Ingen indgriben: No counseling letter (control group)
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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Systolic blood pressure
Tidsramme: Change from baseline mean systolic blood pressure at 12 months
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Reduction of 4 mmHg mean systolic blood pressure in intervention group; Measures: standardized measurements of mean systolic blood pressure (in mmHg)
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Change from baseline mean systolic blood pressure at 12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Waist and hip circumference
Tidsramme: Change from baseline waist and hip circumference at 12 months
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Reduction of waist and hip circumference in intervention group; Measures: standardized measurements of waist and hip circumference (in cm)
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Change from baseline waist and hip circumference at 12 months
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Physical activity by self-report
Tidsramme: Change from baseline physical activity at 12 months
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Measures: assessement via tablet PC or phone calls (International Physical Activity Questionnaire, IPAQ)
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Change from baseline physical activity at 12 months
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Physical activity by accelerometry (if data are available)
Tidsramme: Change from baseline physical activity at 12 months
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Measures: objective measurement of physical activity by accelerometry
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Change from baseline physical activity at 12 months
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Sedentary time by self-report
Tidsramme: Change from baseline sedentary time at 12 months
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Measures: assessement via tablet PC or phone calls (last 7-d sedentary behavior questionnaire, SIT-Q-7d)
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Change from baseline sedentary time at 12 months
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Sedentary behavior by accelerometry (if data are available)
Tidsramme: Change from baseline physical inactivity at 12 months
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Measures: objective measurement of sedentary behavior by accelerometry
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Change from baseline physical inactivity at 12 months
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Smoking by self-report
Tidsramme: Change from baseline smoking at 12 months
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Measures: questions regarding smoking (assessment via tablet PC or phone calls)
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Change from baseline smoking at 12 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Sabina Ulbricht, Dr., Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BB005/17
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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