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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Greifswald、ドイツ、17475
- Institute of Social Medicine and Prevention, University Medicine Greifswald
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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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介入なし: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Systolic blood pressure
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Waist and hip circumference
時間枠: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
時間枠: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)
時間枠: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
時間枠: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)
時間枠: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
時間枠: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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協力者と研究者
捜査官
- スタディチェア:Sabina Ulbricht, Dr.、Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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