Official Title
Constructing an Interactive Mobile Health Cloud Platform of Care Model on Self-management Among the Community-based Type 2 Diabetes Mellitus Patients with Sleep Obstructive Apnea: a Randomized Clinical Trial
Brief Summary

The aim of the second and third year is to construct the "Care model of improving foroverweight or obese T2DM with OSA" based on the transtheoretical model, and to import aninteractive m-health self-management (m-Health My OSA Coach; MOSAC)" cloud platform toexamine the effectiveness of OSA in T2DM participants. A randomized controlled trialstudy design will be adopted. Eligible OSA participants who have been screened for OSAfollowing the first stage will be invited to the second stage. The participants will berandomly divided into either experimental or control group with 1:1 ratio. The totalduration of intervention program is 6 months. Only the experimental group receives theMOSAC intervention.

Detailed Description

Obstructive Sleep Apnea (OSA) is a common sleep disorder. It is estimated that nearly 1
billion adults are affected by OSA in worldwide. It is about 36-60% of Type 2 Diabetes
Mellitus (T2DM) patients with OSA. Studies have shown that obesity is an independent risk
factor for both OSA and T2DM, and the prevalence of obesity among adults in Taiwan has
reached 45.4%. As a result, the incidence of T2DM has also increased annually and has
become younger. For this reason, the OSA derived from it should not be underestimated. A
three-year with longitudinal study will be conducted. In the first year, a
cross-sectional study design is employed. Convenience sampling is used and 485 overweight
community-based participants who will recruit from four diabetes co-care clinics in North
and Central Taiwan. The Epworth Sleep Scale, Pittsburgh's Sleep Quality Index, Taiwanese
depression Scale, Health Promotion Lifestyle Scale, and the home portable sleep monitor
will be used for data collection. The aim of the second and third year is to construct
the "Care model of improving for overweight or obese T2DM with OSA" based on the
transtheoretical model, and to import an interactive m-health self-management (m-Health
My OSA Coach; MOSAC)" cloud platform to examine the effectiveness of OSA in T2DM
participants. A randomized controlled trial study design will be adopted. Eligible OSA
participants who have been screened for OSA following the first stage will be invited to
the second stage. The participants will be randomly divided into either experimental or
control group with 1:1 ratio. The total duration of intervention program is 6 months.
Only the experimental group receives the MOSAC intervention. All data will be collected
at baseline, 3, and 6 months after intervention. Generalized estimating equation is
employed to analyze the effectiveness of the intervention. Hopefully, the findings of
this study will serve as a reference for the health care providers and will help
construct a model of care for people with overweight and obese T2DM with OSA in the
community.

Not yet recruiting
Obstructive Sleep Apnea
Type 2 Diabetes Mellitus (T2DM)

Behavioral: an interactive m-health self-management

Description: The experimental group will undergo a lifestyle intervention based on the
Transtheoretical Model (TTM), utilizing the MOSAC cloud platform. This intervention
focuses on self-management to facilitate behavior changes aimed at weight loss and
improving Obstructive Sleep Apnea (OSA) of T2DM patients. Key components include
self-monitoring, tracking, real-time feedback, and customized weight loss plans, all
enhanced by gamification features. The intervention emphasizes a healthy approach to
weight loss, promoting a balanced diet, moderate calorie reduction, and increased
physical activity, such as step counts. Each stage of the intervention outlines specific
objectives, processes, and measures for achieving behavioral change and supporting
healthy weight loss.

Behavioral: In the control group

Description: In the control group, standard medical care will continue to be provided
along with written educational pamphlets on weight loss and sleep hygiene. The
interactive m-health cloud platform will not be offered. However, the results of the
three questionnaires administered to each participant will be individually explained, and
any questions will be addressed immediately. After the activity concludes, participants
may choose to receive the same intervention as the experimental group, if they wish.

Eligibility Criteria

Inclusion criteria :

- Age over 20 years with a physician-confirmed diagnosis of Type 2 Diabetes Mellitus
(T2DM)

- BMI greater than 24 kg/m2, or waist circumference (WC) greater than 90cm for men or
greater than 80 cm for women

- AHI as evaluated by a home portable sleep monitor at > 5 times/hour and diagnosed
with sleep apnea by a specialist in sleep apnea

- agreeing to participate in this 6-month study .current digital technology product
users.

Exclusion criteria:

- presence of major diseases such as cancer , renal failure or severe depression

- presence of cardiopulmonary diseases not suitable for physical activities

Eligibility Gender
All
Eligibility Age
Minimum: 20 Years ~ Maximum: N/A
Countries
Taiwan
Locations

Primary Healthcare Centers and Diabetes Care Network Clinics
Miaoli, Taiwan

Investigator: CHI CHUN physician, MEDICAL SCHOOL
Contact: 011-886-37664486
hsieh.yu88@gmail.com

Contacts

CHI CHUN physician, master
011-886-37664486
hsieh.yu88@gmail.com

Not Provided

Chang Gung University of Science and Technology
NCT Number
Keywords
Obstructive Sleep Apnea
Type 2 diabetes mellitus
m-health self-management
home portable sleep monitor
MeSH Terms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Diabetes Mellitus
Diabetes Mellitus, Type 2