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Not yet recruiting NCT06169943

Mhealth Social Support for People at Risk of Metabolic Syndrome

No phase Interventional Metabolic Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mHealth social support program, Control.
Who it may be relevant to
Registry conditions: Metabolic Syndrome. Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Mhealth Social Support Program on Health Behaviors Among People at Risk of Metabolic Syndrome: a Feasibility Randomized Controlled Trial

Overview

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

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.

Interventions

  • Other mHealth social support program
    This is a 3-month program comprises mobile app, group discussion, individual telephone contact, and reminders.
  • Other Control
    The same mobile app as the intervention group but with limited function.

Primary outcome measures

  • Physical activity level [Time frame: Baseline, 3, and 6 months]
Secondary outcome measures (8)
  • Healthy eating [Time frame: Baseline, 3, and 6 months]
  • Metabolic syndrome knowledge [Time frame: Baseline, 3, and 6 months]
  • Perceived social support [Time frame: Baseline, 3, and 6 months]
  • Self-efficacy [Time frame: Baseline, 3, and 6 months]
  • Blood pressure [Time frame: Baseline, 3, and 6 months]
  • Waist circumference [Time frame: Baseline, 3, and 6 months]
  • Body weight [Time frame: Baseline, 3, and 6 months]
  • Body fat mass percentage [Time frame: Baseline, 3, and 6 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06169943 · RS-2023-AT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗