Clinical trial NCT06169943: Mhealth Social Support for People at Risk of Metabolic Syndrome
Official title: A Mhealth Social Support Program on Health Behaviors Among People at Risk of Metabolic Syndrome: a Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Keywords: mhealth
metabolic syndrome
lifestyle modifications
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group Control group
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical activity level
timeFrame: Baseline, 3, and 6 months
Secondary outcomes:
measure: Healthy eating
timeFrame: Baseline, 3, and 6 months
measure: Metabolic syndrome knowledge
timeFrame: Baseline, 3, and 6 months
measure: Perceived social support
timeFrame: Baseline, 3, and 6 months
measure: Self-efficacy
timeFrame: Baseline, 3, and 6 months
measure: Blood pressure
timeFrame: Baseline, 3, and 6 months
measure: Waist circumference
timeFrame: Baseline, 3, and 6 months
measure: Body weight
timeFrame: Baseline, 3, and 6 months
measure: Body fat mass percentage
timeFrame: Baseline, 3, and 6 months
Other outcomes:
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