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

11. april 2022 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Agnes YK Lai, PhD
  • Telefonnummer: (+852)3917-6328
  • E-post: agneslai@hku.hk

Studer Kontakt Backup

  • Navn: Mary Ip, MD
  • Telefonnummer: (+852)2255-4455
  • E-post: msmip@hku.hk

Studiesteder

      • Hong Kong, Hong Kong
        • Rekruttering
        • The University of Hong Kong
        • Hovedetterforsker:
          • Agnes YK Lai, PhD
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adults with obstructive sleep apnoea

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Preference on physical activity
Tidsramme: Immediately after obtaining written consent
Outcome-based questions with categorical choices
Immediately after obtaining written consent

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Current physical activity practices
Tidsramme: Immediately after obtaining written consent
Outcome-based questions with categorical choices
Immediately after obtaining written consent
Preference on programme contents and information
Tidsramme: Immediately after obtaining written consent
Outcome-based questions with categorical choices
Immediately after obtaining written consent
Preference on m-Health information
Tidsramme: Immediately after obtaining written consent
Outcome-based questions with categorical choices
Immediately after obtaining written consent
Daytime Sleepiness
Tidsramme: 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
Tidsramme: 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
Tidsramme: Immediately after obtaining written consent
Outcome-based questions with categorical choices
Immediately after obtaining written consent

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Agnes YK Lai, PhD, School of Nursing, The University of Hong Kong

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. mai 2020

Primær fullføring (Forventet)

30. desember 2022

Studiet fullført (Forventet)

30. desember 2022

Datoer for studieregistrering

Først innsendt

6. februar 2020

Først innsendt som oppfylte QC-kriteriene

6. februar 2020

Først lagt ut (Faktiske)

10. februar 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. april 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. april 2022

Sist bekreftet

1. april 2022

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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