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NOT YET RECRUITING
NCT06760715
NA

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

Sponsor: Chang Gung University of Science and Technology

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

162

Start Date

2024-12-30

Completion Date

2025-08-31

Last Updated

2025-01-07

Healthy Volunteers

No

Interventions

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.

Locations (1)

Primary Healthcare Centers and Diabetes Care Network Clinics

Miaoli, Taiwan