An Interactive Mobile Care on Self-management Among T2DM with OSA

NCT ID: NCT06760715

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-30
• Study Completion Date: 2025-08-31

Brief Summary

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.

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.

Conditions

Obstructive Sleep Apnea; Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

m-Health My OSA Coach

Group Type: EXPERIMENTAL

an interactive m-health self-management

Intervention Type: BEHAVIORAL

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.

control group

Group Type: PLACEBO_COMPARATOR

In the control group

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Hsu Hsiu-Chin

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Primary Healthcare Centers and Diabetes Care Network Clinics

Miaoli, , Taiwan

Countries

Taiwan

Central Contacts

CHI CHUN physician, master

Role: CONTACT

hsieh.yu88@gmail.com

011-886-37664486

Facility Contacts

CHI CHUN physician, MEDICAL SCHOOL

Role: primary

hsieh.yu88@gmail.com

011-886-37664486

Other Identifiers

IRB No.: 202202281B0

Identifier Type: -

Identifier Source: org_study_id