Mhealth Social Support for People at Risk of Metabolic Syndrome

NCT ID: NCT06169943

Last Updated: 2024-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-05-31

Brief Summary

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This trial is to examine the feasibility, acceptability, and preliminary effect of a mHealth social support program on lifestyle modifications among people at risk of metabolic syndrome in Hong Kong at 3- and 6-month follow-ups.

Detailed Description

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Metabolic syndrome is a cluster of unhealthy conditions that affects more than 1 billion people in the world. Lifestyle modifications can reduce the risk to develop metabolic syndrome, while the report showed that over 95% of people in Hong Kong did not practice healthy lifestyle. This trial is to examine the feasibility, acceptability, and preliminary effect of a mHealth social support program on lifestyle modifications among people at risk of metabolic syndrome in Hong Kong. Eighty eligible participants will be recruited from community centers and be randomized into intervention group or control group. Participants in the control group will receive a mobile app with limited function, while those in the intervention group will receive a theory-guided mhealth social support program. Data will be collected at baseline, 3 months, and 6 months on the outcomes of feasibility, acceptability, and lifestyle modifications. Data will be analyzed using a generalized estimating equation based on the intention-to-treat principle. The findings of this study will provide valuable information for a full randomized controlled trial.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention group Control group
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessor will be blinded to the participants' group allocation throughout the study.

Study Groups

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Control

Participants in the control group will receive the same mobile app as the intervention group but with limited function.

Group Type OTHER

Control

Intervention Type OTHER

The same mobile app as the intervention group but with limited function.

Intervention

Participants in the intervention group will receive the mHealth social support program.

Group Type EXPERIMENTAL

mHealth social support program

Intervention Type OTHER

This is a 3-month program comprises mobile app, group discussion, individual telephone contact, and reminders.

Interventions

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mHealth social support program

This is a 3-month program comprises mobile app, group discussion, individual telephone contact, and reminders.

Intervention Type OTHER

Control

The same mobile app as the intervention group but with limited function.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Chinese adults aged ≥ 45 years
2. With central obesity according to IDF criteria
3. Being treated of hypertension, dyslipidemia, or diabetes
4. Able to give informed consent
5. Attain at least 6 years of formal education
6. Have a smartphone with internet connection and able to use WhatsApp

Exclusion Criteria

1. Concurrently participating in another clinical trial, lifestyle/dietary intervention, or weight control program
2. Known history of psychiatric disorders
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Hon Lon Tam

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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RS-2023-AT

Identifier Type: -

Identifier Source: org_study_id

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