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A Brief Lifestyle Modification Programme in Overweight Subjects With Obstructive Sleep Apnoea - Needs Assessment

2022年4月11日 更新者:Dr. Agnes Yuen-Kwan Lai、The University of Hong Kong

A Brief Motivational Enhancement Lifestyle Modification Programme to Reduce Body Weight in Overweight Subjects With OSA: Needs Assessment

Obstructive sleep apnea (OSA) is a common chronic disease and associated with cardiovascular and neurocognitive sequelae. Overweight is a common, reversible risk factor of OSA, and the rapid rise in obesity worldwide may lead to increases in OSA and related adverse health outcomes. Weight-loss interventions, especially comprehensive lifestyle interventions, are associated with improvements in OSA severity, cardiometabolic comorbidities, and quality of life. However, the intensive nature of these programmes often pose a barrier to adherence. Furthermore, although there is strong evidence to support the value of mobile text messaging to promote physical activity and healthy eating in clinical and community settings, messaging has rarely been applied in interventions for overweight OSA subjects.

The proposed study aims to examine the feasibility of a brief lifestyle modification programme that makes use of smartphone technology (WhatsApp or WeChat) to empower subjects to start doing simple and easy-to-do exercises that can be easily integrated into daily life for gradual lifestyle change.

研究概览

地位

招聘中

详细说明

Obstructive sleep apnea (OSA) is a common chronic disease and associated with cardiovascular and neurocognitive sequelae. Overweight is a common, reversible risk factor of OSA, and the rapid rise in obesity worldwide may lead to increases in OSA and related adverse health outcomes. Weight-loss interventions, especially comprehensive lifestyle interventions, are associated with improvements in OSA severity, cardiometabolic comorbidities, and quality of life. However, non-adherence is commonly seen in such lifestyle modification programmes. Such programmes are often intensive and pose a barrier to adherence. Researchers have suggested that programmes with fewer sessions may improve the completion rates. As yet, there have been no randomised trial assessing the feasibility and effectiveness of a brief theory-based lifestyle modification programme.

Furthermore, although there is strong evidence to support the value of mobile text messaging to promote physical activity and healthy eating in clinical and community settings, messaging has rarely been applied in interventions for overweight OSA subjects. In Hong Kong, where smartphone penetration is extensive (89% in 2017), utilising messaging as an intervention tool may be especially valuable.

The proposed study will examine the perceived burden and informational needs and preferences of overweight subjects with OSA, especially in relation to physical activity. The study will also examine the feasibility of a brief lifestyle modification programme that makes use of smartphone technology (WhatsApp or WeChat) to provide personalised support and empower subjects to start doing simple and easy-to-do exercises that can be easily integrated into daily life for gradual lifestyle change and weight reduction.

研究类型

观察性的

注册 (预期的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Agnes YK Lai, PhD
  • 电话号码:(+852)3917-6328
  • 邮箱agneslai@hku.hk

研究联系人备份

  • 姓名:Mary Ip, MD
  • 电话号码:(+852)2255-4455
  • 邮箱msmip@hku.hk

学习地点

      • Hong Kong、香港
        • 招聘中
        • The University of Hong Kong
        • 首席研究员:
          • Agnes YK Lai, PhD
        • 接触:
          • Agnes YK Lai, PhD
          • 电话号码:(+852)3917-6328
          • 邮箱agneslai@hku.hk

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adults with obstructive sleep apnoea

描述

Inclusion Criteria:

  • Aged 18 years or above;
  • Performed sleep test in sleep laboratory; and
  • Mentally fit to provide informed consent and answer self-administered questionnaire.

Exclusion Criteria:

  • Those on CPAP or oral appliance treatment;
  • Diagnosed with psychiatric illness; or
  • Unwilling to give informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Preference on physical activity
大体时间:Immediately after obtaining written consent
Outcome-based questions with categorical choices
Immediately after obtaining written consent

次要结果测量

结果测量
措施说明
大体时间
Current physical activity practices
大体时间:Immediately after obtaining written consent
Outcome-based questions with categorical choices
Immediately after obtaining written consent
Preference on programme contents and information
大体时间:Immediately after obtaining written consent
Outcome-based questions with categorical choices
Immediately after obtaining written consent
Preference on m-Health information
大体时间:Immediately after obtaining written consent
Outcome-based questions with categorical choices
Immediately after obtaining written consent
Daytime Sleepiness
大体时间:Immediately after obtaining written consent
Epworth Sleepiness Scale, ranged from 0 - 24 scores. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life. Score >10 is interpreted as excessive daytime sleepiness
Immediately after obtaining written consent
Sleep quality
大体时间:Immediately after obtaining written consent
A single-item sleep quality scale; range from 0 -10; Higher score is interpreted as better sleep quality
Immediately after obtaining written consent
Dietary consumption habits
大体时间:Immediately after obtaining written consent
Outcome-based questions with categorical choices
Immediately after obtaining written consent

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Agnes YK Lai, PhD、School of Nursing, The University of Hong Kong

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年5月11日

初级完成 (预期的)

2022年12月30日

研究完成 (预期的)

2022年12月30日

研究注册日期

首次提交

2020年2月6日

首先提交符合 QC 标准的

2020年2月6日

首次发布 (实际的)

2020年2月10日

研究记录更新

最后更新发布 (实际的)

2022年4月13日

上次提交的符合 QC 标准的更新

2022年4月11日

最后验证

2022年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

Subject consent did not include sharing personal information to other researchers.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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