Mhealth Social Support for People at Risk of Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06169943
• Other study ID #: RS-2023-AT
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Healthy eating	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.	Baseline, 3, and 6 months
Secondary	Metabolic syndrome knowledge	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.	Baseline, 3, and 6 months
Secondary	Perceived social support	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.	Baseline, 3, and 6 months
Secondary	Self-efficacy	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.	Baseline, 3, and 6 months
Secondary	Blood pressure	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.	Baseline, 3, and 6 months
Secondary	Waist circumference	Measured in the nearest 0.1 centimeter.	Baseline, 3, and 6 months
Secondary	Body weight	Measured in the nearest 0.1 kilogram.	Baseline, 3, and 6 months
Secondary	Body fat mass percentage	Body fat mass percentage will be assessed by a calibrated digital body composition monitor.	Baseline, 3, and 6 months