- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04262986
A Brief Lifestyle Modification Programme in Overweight Subjects With Obstructive Sleep Apnoea - Needs Assessment
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Agnes YK Lai, PhD
- 전화번호: (+852)3917-6328
- 이메일: agneslai@hku.hk
연구 연락처 백업
- 이름: Mary Ip, MD
- 전화번호: (+852)2255-4455
- 이메일: msmip@hku.hk
연구 장소
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Hong Kong, 홍콩
- 모병
- The University of Hong Kong
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수석 연구원:
- Agnes YK Lai, PhD
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연락하다:
- Agnes YK Lai, PhD
- 전화번호: (+852)3917-6328
- 이메일: agneslai@hku.hk
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Preference on physical activity
기간: Immediately after obtaining written consent
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Outcome-based questions with categorical choices
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Immediately after obtaining written consent
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Current physical activity practices
기간: Immediately after obtaining written consent
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Outcome-based questions with categorical choices
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Immediately after obtaining written consent
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Preference on programme contents and information
기간: Immediately after obtaining written consent
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Outcome-based questions with categorical choices
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Immediately after obtaining written consent
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Preference on m-Health information
기간: Immediately after obtaining written consent
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Outcome-based questions with categorical choices
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Immediately after obtaining written consent
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Daytime Sleepiness
기간: Immediately after obtaining written consent
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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
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Immediately after obtaining written consent
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Sleep quality
기간: Immediately after obtaining written consent
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A single-item sleep quality scale; range from 0 -10; Higher score is interpreted as better sleep quality
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Immediately after obtaining written consent
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Dietary consumption habits
기간: Immediately after obtaining written consent
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Outcome-based questions with categorical choices
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Immediately after obtaining written consent
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공동 작업자 및 조사자
수사관
- 수석 연구원: Agnes YK Lai, PhD, School of Nursing, The University of Hong Kong
간행물 및 유용한 링크
일반 간행물
- Hall AK, Cole-Lewis H, Bernhardt JM. Mobile text messaging for health: a systematic review of reviews. Annu Rev Public Health. 2015 Mar 18;36:393-415. doi: 10.1146/annurev-publhealth-031914-122855.
- Dobrosielski DA, Papandreou C, Patil SP, Salas-Salvado J. Diet and exercise in the management of obstructive sleep apnoea and cardiovascular disease risk. Eur Respir Rev. 2017 Jun 28;26(144):160110. doi: 10.1183/16000617.0110-2016. Print 2017 Jun 30.
- Hudgel DW, Patel SR, Ahasic AM, Bartlett SJ, Bessesen DH, Coaker MA, Fiander PM, Grunstein RR, Gurubhagavatula I, Kapur VK, Lettieri CJ, Naughton MT, Owens RL, Pepin JL, Tuomilehto H, Wilson KC; American Thoracic Society Assembly on Sleep and Respiratory Neurobiology. The Role of Weight Management in the Treatment of Adult Obstructive Sleep Apnea. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2018 Sep 15;198(6):e70-e87. doi: 10.1164/rccm.201807-1326ST.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UW 20-068-1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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