- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Greifswald, Allemagne, 17475
- Institute of Social Medicine and Prevention, University Medicine Greifswald
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Systolic blood pressure
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Waist and hip circumference
Délai: 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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Sabina Ulbricht, Dr., Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BB005/17
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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