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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04262986
• Other study ID #: UW 20-068-1
• Status: Recruiting
• Start date: May 11, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: April 2022
• Source: The University of Hong Kong
• Contact: Agnes YK Lai, PhD
• Phone: (+852)3917-6328
• Email: agneslai[@]hku.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnoea
• Overweight
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (3)

Dobrosielski DA, Papandreou C, Patil SP, Salas-Salvadó J. Diet and exercise in the management of obstructive sleep apnoea and cardiovascular disease risk. Eur Respir Rev. 2017 Jun 28;26(144). pii: 160110. doi: 10.1183/16000617.0110-2016. Print 2017 Jun 30. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preference on physical activity	Outcome-based questions with categorical choices	Immediately after obtaining written consent
Secondary	Current physical activity practices	Outcome-based questions with categorical choices	Immediately after obtaining written consent
Secondary	Preference on programme contents and information	Outcome-based questions with categorical choices	Immediately after obtaining written consent
Secondary	Preference on m-Health information	Outcome-based questions with categorical choices	Immediately after obtaining written consent
Secondary	Daytime Sleepiness	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
Secondary	Sleep quality	A single-item sleep quality scale; range from 0 -10; Higher score is interpreted as better sleep quality	Immediately after obtaining written consent
Secondary	Dietary consumption habits	Outcome-based questions with categorical choices	Immediately after obtaining written consent

External Links

•   HKSAR Thematic Household Survey: Personal computer and Internet penetration