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.

Study Overview

• Status: Recruiting
• Conditions: Overweight; Obstructive Sleep Apnoea

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Agnes YK Lai, PhD; Phone Number: (+852)3917-6328; Email: agneslai@hku.hk
• Study Contact Backup: Name: Mary Ip, MD; Phone Number: (+852)2255-4455; Email: msmip@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The University of Hong Kong
    • Principal Investigator: Agnes YK Lai, PhD
    • Contact: Agnes YK Lai, PhD; Phone Number: (+852)3917-6328; Email: agneslai@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with obstructive sleep apnoea

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preference on physical activity	Outcome-based questions with categorical choices	Immediately after obtaining written consent

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Current physical activity practices	Outcome-based questions with categorical choices	Immediately after obtaining written consent
Preference on programme contents and information	Outcome-based questions with categorical choices	Immediately after obtaining written consent
Preference on m-Health information	Outcome-based questions with categorical choices	Immediately after obtaining written consent
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
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
Dietary consumption habits	Outcome-based questions with categorical choices	Immediately after obtaining written consent

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Agnes YK Lai, PhD, School of Nursing, The University of Hong Kong

Publications and helpful links

General Publications

• 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.

Helpful Links

• HKSAR Thematic Household Survey: Personal computer and Internet penetration

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Overweight; Lifestyle modification; Obstructive sleep apnoea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Body Weight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Overweight
• Other Study ID Numbers: UW 20-068-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Subject consent did not include sharing personal information to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No