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临床试验/NCT03135561
NCT03135561已完成不适用

A Pedometer-based Walking Intervention With and Without Email Counselling in General Practice: a Pilot Randomised Controlled Trial

Charles University, Czech Republic0 个研究点目标入组 37 人开始时间: 2015年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
主要终点
average daily step count

研究概览

简要总结

A two-arm parallel randomised controlled trial comparing pedometer-based intervention with and without email counselling in a primary care setting. Physically inactive patients from four general practices will be randomised to the pedometer-plus-email group or to the pedometer-alone group. All patients will be instructed to gradually increase the daily number of steps to at least 10,000. Patients in the pedometer-plus-email group will receive 8 counselling emails based on behavioural techniques. The primary outcome will be change in average daily steps measured during 7-day period at baseline and at 12 weeks.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • physically inactive, i.e. takes less than 8,000 steps per day at baseline
  • registered at the participating general practice,
  • over 18 years of age,
  • regular email user, and willing to use email for the purpose of the study,
  • has a home computer with access to the Internet.

排除标准

  • medical or psychiatric condition which the general practitioner considers as inappropriate for participating in the intervention (e.g., terminal illness, psychotic illness, chronic disorders or diseases that seriously influence the ability to be physically active, dementia or significant cognitive impairment, unable to move about independently),
  • medical, personal of family condition which the general practitioner considers temporarily affects mean daily step count at baseline (e.g., acute illness, holiday or business trip),
  • pregnant woman,
  • currently engaging in regular sports or exercise (at least twice a week),
  • failure to upload pedometer data to a website at baseline assessment,
  • failure to give informed consent with the study.

结局指标

主要结局

average daily step count

时间窗: 12 weeks

change in average daily steps measured during 7-day period at baseline and at 12 weeks

次要结局

  • hip circumference(12 weeks)
  • diastolic blood pressure(12 weeks)
  • body weight(12 weeks)
  • waist circumference(12 weeks)
  • systolic blood pressure(12 weeks)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tomáš Větrovský

PhD Student

Charles University, Czech Republic

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