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

NCT06760715 | Not Yet Recruiting

• 1 other identifier: IRB No.: 202202281B0
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Type 2 Diabetes Mellitus (T2DM)

Keywords

Obstructive Sleep Apnea; Type 2 Diabetes Mellitus; m-health self-management; home portable sleep monitor

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the change in AHI (times/hour) detected by a home-use portable sleep monitor.

  AHI is represented by the number of apnea and hypopnea events per hour of sleep. In this study, OSA was defined as the value of AHI greater than 5 events/ hr. In addition, participants were determined as having mild, moderate, and severe OSA if they had AHI 5-14 events /hr, 15-30 events /hr, and \> 30 events /hr, respectively (Jonas et al., 2017).

  24weeks

Secondary Outcomes (1)

• The secondary outcome measures include changes in OSA-related factors such as HbA1c, BMI, sleep quality, daytime sleepiness, depression, and health-promoting lifestyle.

  24weeks

Study Arms (2)

m-Health My OSA Coach

EXPERIMENTAL

Behavioral: an interactive m-health self-management

control group

PLACEBO COMPARATOR

Behavioral: In the control group

Interventions

an interactive m-health self-management 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.

m-Health My OSA Coach

In the control group 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.

control group

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• presence of major diseases such as cancer , renal failure or severe depression
• presence of cardiopulmonary diseases not suitable for physical activities

Sponsors & Collaborators

• Chang Gung University of Science and Technology: lead

Study Sites (1)

Primary Healthcare Centers and Diabetes Care Network Clinics

Miaoli, 351, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

CHI CHUN physician, master

CONTACT

011-886-37664486; hsieh.yu88@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: January 7, 2025
• Study Start: December 30, 2024
• Primary Completion: February 15, 2025
• Study Completion: August 31, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)