MedPath

Mhealth Social Support for People at Risk of Metabolic Syndrome

Not Applicable
Not yet recruiting
Conditions
Metabolic Syndrome
Interventions
Other: Control
Other: mHealth social support program
Registration Number
NCT06169943
Lead Sponsor
Chinese University of Hong Kong
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
80
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
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Exclusion Criteria
  1. Concurrently participating in another clinical trial, lifestyle/dietary intervention, or weight control program
  2. Known history of psychiatric disorders
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ControlControlParticipants in the control group will receive the same mobile app as the intervention group but with limited function.
InterventionmHealth social support programParticipants in the intervention group will receive the mHealth social support program.
Primary Outcome Measures
NameTimeMethod
Physical activity levelBaseline, 3, and 6 months

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

Secondary Outcome Measures
NameTimeMethod
Healthy eatingBaseline, 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.

Self-efficacyBaseline, 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.

Waist circumferenceBaseline, 3, and 6 months

Measured in the nearest 0.1 centimeter.

Body fat mass percentageBaseline, 3, and 6 months

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

Metabolic syndrome knowledgeBaseline, 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.

Perceived social supportBaseline, 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.

Blood pressureBaseline, 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.

Body weightBaseline, 3, and 6 months

Measured in the nearest 0.1 kilogram.

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