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NCT Number: NCT06169943

Mhealth Social Support for People at Risk of Metabolic Syndrome

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.

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Key information

Conditions

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

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mHealth social support program

Other

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

Control

Other

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

Primary outcomes

  1. 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

  1. Healthy eating

    Time frame: Baseline, 3, and 6 months

    Diet subscale of the Chinese version of Health Promoting Lifestyle Profile II. The subscale includes eight items measuring healthy eating on a 4-point Likert scale (1=never to 4=routinely), ranged from 8-32. The higher sum score indicates more adoption of healthy eating.

  2. Metabolic syndrome knowledge

    Time frame: Baseline, 3, and 6 months

    Chinese version of metabolic syndrome knowledge scale. 10 items cover three domains: definition and diagnosis (5 items), complications (2 items), and preventions (3 items); a higher sum score indicates better understanding of metabolic syndrome.

  3. Perceived social support

    Time frame: Baseline, 3, and 6 months

    Chinese version of multidimensional scale of perceived social support. 12 items measuring perceived support from family and friends; 7-point Likert scale (1=strongly disagree to 7=strongly agree), ranged from 12 -84; a higher sum score indicates more social support is perceived.

  4. Self-efficacy

    Time frame: Baseline, 3, and 6 months

    Nutrition and Exercise subscale of the Chinese version of Self-rated Abilities for Health Practices.

    7 items measuring diet self-efficacy and 7 items measuring PA self-efficacy; five-point Likert scale (0=not confident to 4=very confident) that a higher score indicates higher confidence to adopt lifestyle modifications in daily life.

  5. Blood pressure

    Time frame: Baseline, 3, and 6 months

    Both systolic blood pressure and diastolic blood pressure will be measured by a validated and reliable upper-arm automated system (in mmHg) after resting for 20 minutes; an average of two measurements with 1-minute apart is recorded.

  6. Waist circumference

    Time frame: Baseline, 3, and 6 months

    Measured in the nearest 0.1 centimeter.

  7. Body weight

    Time frame: Baseline, 3, and 6 months

    Measured in the nearest 0.1 kilogram.

  8. Body fat mass percentage

    Time frame: Baseline, 3, and 6 months

    Body fat mass percentage will be assessed by a calibrated digital body composition monitor.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 14, 2023
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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