- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Greifswald, Germania, 17475
- Institute of Social Medicine and Prevention, University Medicine Greifswald
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
|
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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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Systolic blood pressure
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Waist and hip circumference
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Sabina Ulbricht, Dr., Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BB005/17
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