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临床试验/NCT03077373
NCT03077373已完成不适用

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

University Medicine Greifswald2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2017年1月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
试验地点
2
主要终点
Systolic blood pressure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • men and women aged between 40 and 65 years
  • mean systolic blood pressure ≥ 130 mmHg at baseline

排除标准

  • cardiovascular event (myocardial infarction, stroke)
  • vascular intervention
  • cognitive impairment
  • inadequate language skills
  • severe disease with reduced life expectancy (< 2 years)

研究组 & 干预措施

Counseling letter (intervention group)

Experimental

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.

干预措施: Counseling letter (Behavioral)

No counseling letter (control group)

No Intervention

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.

结局指标

主要结局

Systolic blood pressure

时间窗: Change from baseline mean systolic blood pressure at 12 months

Reduction of 4 mmHg mean systolic blood pressure in intervention group; Measures: standardized measurements of mean systolic blood pressure (in mmHg)

次要结局

  • Physical activity by self-report(Change from baseline physical activity at 12 months)
  • Physical activity by accelerometry (if data are available)(Change from baseline physical activity at 12 months)
  • Sedentary behavior by accelerometry (if data are available)(Change from baseline physical inactivity at 12 months)
  • Smoking by self-report(Change from baseline smoking at 12 months)
  • Waist and hip circumference(Change from baseline waist and hip circumference at 12 months)
  • Sedentary time by self-report(Change from baseline sedentary time at 12 months)

研究者

发起方
University Medicine Greifswald
申办方类型
Other
责任方
Sponsor

研究点 (2)

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