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Clinical Trials/NCT06169943
NCT06169943
Not yet recruiting
Not Applicable

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

Chinese University of Hong Kong0 sites80 target enrollmentSeptember 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
Chinese University of Hong Kong
Enrollment
80
Primary Endpoint
Physical activity level
Status
Not yet recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2024
End Date
May 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hon Lon Tam

Principal Investigator

Chinese University of Hong Kong

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

Outcomes

Primary Outcomes

Physical activity level

Time Frame: Baseline, 3, and 6 months

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

Secondary Outcomes

  • Healthy eating(Baseline, 3, and 6 months)
  • Self-efficacy(Baseline, 3, and 6 months)
  • Waist circumference(Baseline, 3, and 6 months)
  • Body fat mass percentage(Baseline, 3, and 6 months)
  • Metabolic syndrome knowledge(Baseline, 3, and 6 months)
  • Perceived social support(Baseline, 3, and 6 months)
  • Blood pressure(Baseline, 3, and 6 months)
  • Body weight(Baseline, 3, and 6 months)

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