- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Agnes YK Lai, PhD
- Telefonnummer: (+852)3917-6328
- E-Mail: agneslai@hku.hk
Studieren Sie die Kontaktsicherung
- Name: Mary Ip, MD
- Telefonnummer: (+852)2255-4455
- E-Mail: msmip@hku.hk
Studienorte
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Hong Kong, Hongkong
- Rekrutierung
- The University of Hong Kong
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Hauptermittler:
- Agnes YK Lai, PhD
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Kontakt:
- Agnes YK Lai, PhD
- Telefonnummer: (+852)3917-6328
- E-Mail: agneslai@hku.hk
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Preference on physical activity
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Current physical activity practices
Zeitfenster: 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
Zeitfenster: Immediately after obtaining written consent
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Outcome-based questions with categorical choices
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Immediately after obtaining written consent
|
Preference on m-Health information
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Agnes YK Lai, PhD, School of Nursing, The University of Hong Kong
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- UW 20-068-1
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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