Mhealth Social Support for People at Risk of Metabolic Syndrome

NCT06169943 | Not Yet Recruiting

• 1 other identifier: RS-2023-AT
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Metabolic Syndrome

Keywords

mhealth; metabolic syndrome; lifestyle modifications

Outcome Measures

Primary Outcomes (1)

• Physical activity level

  Total exercise amount will be quantified with a modified version of the Godin-Shephard Leisure-Time Physical Activity Questionnaire.

  Baseline, 3, and 6 months

Secondary Outcomes (8)

• Healthy eating

  Baseline, 3, and 6 months

• Metabolic syndrome knowledge

  Baseline, 3, and 6 months

• Perceived social support

  Baseline, 3, and 6 months

• Self-efficacy

  Baseline, 3, and 6 months

• Blood pressure

  Baseline, 3, and 6 months

Study Arms (2)

Control

OTHER

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

Other: Control

Intervention

EXPERIMENTAL

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

Other: mHealth social support program

Interventions

mHealth social support program OTHER

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

Intervention

Control OTHER

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

Control

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Concurrently participating in another clinical trial, lifestyle/dietary intervention, or weight control program
• Known history of psychiatric disorders

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to the participants' group allocation throughout the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention group Control group

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 14, 2023
• Study Start: September 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: May 1, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share