a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adults With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): App group; Booklet group; control group
Intervention type(s): Other; Other; Other
Intervention description(s): Intervention group the participants will receive a Lifestyle Intervention Program (LIP) with the support of MetS mobile application (MetS app). The MetS app support include app installment and briefing by a research assistant after the educational talk. The participants can view the similar knowledge content related to metabolic syndrome in their own smart phone. In addition, a membership area provides individual support of self- health monitoring, goal setting of exercise plan and exercise record. A user guide of the MetS app will be provided to the participants to take home after the briefing.; The participants will additionally receive a Hong Kong version LIP booklet to take home and use for 24 weeks. The major component of the LIP booklet consists of fact of metabolic syndrome, advise of diet, exercise, medication, life style and stress management.; Participants will be advised to maintain their usual activities. They will additionally receive a placebo health leaflet. The health leaflets are produced by Department of Health and commonly distributed to the general public. For the ethical reason, those control group participants are freely to receive the LIP booklet after completion of the study at 24 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A multisite randomized controlled trial with three arms : app group, booklet and leaflet
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: life style modification program; mobile application; booklet; exercise; body weight; randomized control trial; metabolic syndrome; adult