Mhealth Social Support for People at Risk of Metabolic Syndrome

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Other: Control; Other: mHealth social support program

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; Participants in the control group will receive the same mobile app as the intervention group but with limited function.	Other: Control; The same mobile app as the intervention group but with limited function.
Experimental: Intervention; Participants in the intervention group will receive the mHealth social support program.	Other: mHealth social support program; This is a 3-month program comprises mobile app, group discussion, individual telephone contact, and reminders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Waist circumference	Measured in the nearest 0.1 centimeter.	Baseline, 3, and 6 months
Body weight	Measured in the nearest 0.1 kilogram.	Baseline, 3, and 6 months
Body fat mass percentage	Body fat mass percentage will be assessed by a calibrated digital body composition monitor.	Baseline, 3, and 6 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: metabolic syndrome; mhealth; lifestyle modifications
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: RS-2023-AT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No