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

Summary: 
      Aims This Pilot study aims to develop and determine the feasibility and acceptability of a
      mobile application (MetS app) together with a modified Life style modification Program (LIP)
      for soon-to-aged adults with metabolic syndrome (MetS) and to determine the sample size for
      the main RCT. .

      Methods A prospective randomized control trial design with process evaluation will be
      adopted. Inclusion criteria are those MetS participants, age 45 or above, able to use a smart
      phone. A total of eighty eligible participants will be recruited from 2-3 community Centres.
      Control group will receive standard care while intervention group will receive a MetS app.
      Standard care consists of a modified three-month lifestyle modification booklet, a 30 minutes
      educational session. The intervention group will receive a 30 minute education session plus
      MetS support, which will be guided by health belief model to support an individual self-
      monitoring and record of health measures (body weight, blood pressure, waist circumference)
      and physical exercise (goal setting of exercise and record) across three months. All
      information from the LIP booklet are also installed in the MetS platform as well. The primary
      outcomes will be waist measure and the total physical exercise (GSLTPAQ). The secondary
      outcomes included cardio-metabolic risk factors, cardiovascular endurance, self-efficacy for
      exercise (SEE) and stress level (PSS-10) and quality of Life (SF12). Data will be collected
      at baseline, one-month (T1) and three-month (T2). SPSS version 23 and Generalized Estimating
      equations (GEE) model will be employed to examine the effects of the LIP with MetS app
      support.
    

Detailed description: 
      Background Educational programme intervention on Lifestyle modification is recommended as the
      primary intervention for metabolic syndrome (MetS), a cluster of cardio-metabolic risk
      factors with a high prevalence rate globally and locally. Recent studies of lifestyle
      intervention program (LIP) have been reported as effective on physical indicators and quality
      of life (QoL) among MetS adult. However, they have the challenges in the delivery in making
      care scalable and little is known about the effect on exercise outcomes such as total
      exercise, cardiovascular endurance after exercise as well as whether the outcomes of this
      programme can be applied in Hong Kong and improved by adding the mobile application.

      Aims This Pilot study aims to develop and determine the feasibility and acceptability of a
      mobile application (MetS app) together with a modified Life style modification Program (LIP)
      for soon-to-aged adults with metabolic syndrome (MetS) and to determine the sample size for
      the main RCT. .

      Methods A prospective randomized control trial design with process evaluation will be
      adopted. Inclusion criteria are those MetS participants, age 45 or above, able to use a smart
      phone. A total of eighty eligible participants will be recruited from 2-3 community Centres.
      Control group will receive standard care while intervention group will receive a MetS app.
      Standard care consists of a modified three-month lifestyle modification booklet, a 30 minutes
      educational session. The intervention group will receive a 30 minute education session plus
      MetS support, which will be guided by health belief model to support an individual self-
      monitoring and record of health measures (body weight, blood pressure, waist circumference)
      and physical exercise (goal setting of exercise and record) across three months. All
      information from the LIP booklet are also installed in the MetS platform as well. The primary
      outcomes will be waist measure and the total physical exercise (GSLTPAQ). The secondary
      outcomes included cardio-metabolic risk factors, cardiovascular endurance, self-efficacy for
      exercise (SEE) and stress level (PSS-10) and quality of Life (SF12). Data will be collected
      at baseline, one-month (T1) and three-month (T2). SPSS version 23 and Generalized Estimating
      equations (GEE) model will be employed to examine the effects of the LIP with MetS app
      support.

      Significance This pilot study will provide insights to guide the main study. The findings
      will facilitate the development of MetS app that could support the self-efficacy for physical
      health monitoring and exercise of patients with MetS. Such programme may enhance patient's
      self-management and monitoring of MetS, exercise behavior sustainability that will be
      beneficial to reduced MetS risk profile, and improves psychological health and quality of
      life.
    

Intervention name(s): mobile application
Intervention type(s): Other
Intervention description(s): Mobile app: The participants can view the Life style modification program by using the app. In addition, a membership area of the app 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.
Booklet : The booklet content covers 26 pages about the metabolic syndrome and risk factors, suggested life style modification tips in terms of exercise, diet, smoking, mediation and stress management.
Other intervention name(s): Booklet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A multisite randomized controlled trial with two arms: MetS app group and , booklet group
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: life style modification program; mobile application; metabolic sydrome; booklet; RCT