a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adults With Metabolic Syndrome

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    360
  • sponsor
    The Hong Kong Polytechnic University
Updated on 18 July 2021
diabetes
hypertension
fasting
systolic blood pressure
cholesterol level
plasma glucose
hdl cholesterol
central obesity
serum hdl cholesterol

Summary

The study aims to compare the effect of a lifestyle intervention programme (LIP) using mobile application (MetS app) vs using booklet for MetS adults living in the community.

Description

The study aims to compare the effect of a lifestyle intervention programme (LIP) using mobile application (MetS app) vs using booklet for MetS adults living in the community.

Methods A multi-site randomized controlled trial (RCT) with three arms, namely, MetS app group (Group A), booklet group (Group B), and control group (group C). Three hundred and sixty subjects will be recruited from six community centers and randomized into either one arm. Inclusion criteria are those MetS adult, able to use a smart phone. Group a participants will receive a 30-minute educational session and a MetS app while Group B will receive same educational session and a MetS booklet and the control group receive a placebo booklet only. The MetS app or booklet, has been well developed by the team with the support of internal grant, aims to support MetS individual's self- monitoring and record of health measures (body weight, blood pressure, waist circumference) and exercise. The primary outcomes of this study include the body weight and total physical exercise (GSLTPAQ). The secondary outcomes include cardiometabolic risk factors, cardiovascular endurance, self-efficacy for exercise (SEE) and stress level (PSS-10). Data will be collected at baseline (T1), 4 week (T2) and week 12 (T3) and week 24 (T4). SPSS and Generalized Estimating equations (GEE) model will be employed for data analysis.

Significance This study will provide empirical evidence and inform about the effective way to enhance patient's self-management of MetS, exercise sustainability that will be beneficial to clients' health.

Details
Condition Metabolic disorder, Metabolic syndrome, Metabolic Disorders, metabolic syndrome x
Treatment Control group, App group, Booklet group
Clinical Study IdentifierNCT03778788
SponsorThe Hong Kong Polytechnic University
Last Modified on18 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Ethnic Chinese client who has a smart phone
Adult age 18 or over
MetS Clients with central obesity (male >90 cm , female > 80cm ) plus two items of the followings
Raised triglycerides 150 mg/dL (1.7 mmol/L) or specific treatment for this lipid abnormality
Reduced HDL cholesterol < 40 mg/dL (1.03 mmol/L) in males < 50 mg/dL (1.29 mmol/L) in females or treatment for this lipid abnormality
Raised blood pressure systolic BP 130 or diastolic BP 85 mm Hg or treatment of previously diagnosed hypertension (HT)
Raised fasting plasma glucose (FPG) 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes (DM) -

Exclusion Criteria

Clients with physical, mental, visual, or cognitive impairments with regular medical follow-ups and treatment, and those who have musculoskeletal disorders or other disabling diseases that may limit the practice of walking exercise will be excluded. Client receiving prescription of medication for weight reduction will be excluded as well
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