<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03762434</url>
  </required_header>
  <id_info>
    <org_study_id>1-BE0N</org_study_id>
    <nct_id>NCT03762434</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adult With Metabolic Syndrome</brief_title>
  <official_title>The Effectiveness of a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adult With Metabolic Syndrome _ a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aims This Pilot study aims to develop and determine the feasibility and acceptability of a&#xD;
      mobile application (MetS app) together with a modified Life style modification Program (LIP)&#xD;
      for soon-to-aged adults with metabolic syndrome (MetS) and to determine the sample size for&#xD;
      the main RCT. .&#xD;
&#xD;
      Methods A prospective randomized control trial design with process evaluation will be&#xD;
      adopted. Inclusion criteria are those MetS participants, age 45 or above, able to use a smart&#xD;
      phone. A total of eighty eligible participants will be recruited from 2-3 community Centres.&#xD;
      Control group will receive standard care while intervention group will receive a MetS app.&#xD;
      Standard care consists of a modified three-month lifestyle modification booklet, a 30 minutes&#xD;
      educational session. The intervention group will receive a 30 minute education session plus&#xD;
      MetS support, which will be guided by health belief model to support an individual self-&#xD;
      monitoring and record of health measures (body weight, blood pressure, waist circumference)&#xD;
      and physical exercise (goal setting of exercise and record) across three months. All&#xD;
      information from the LIP booklet are also installed in the MetS platform as well. The primary&#xD;
      outcomes will be waist measure and the total physical exercise (GSLTPAQ). The secondary&#xD;
      outcomes included cardio-metabolic risk factors, cardiovascular endurance, self-efficacy for&#xD;
      exercise (SEE) and stress level (PSS-10) and quality of Life (SF12). Data will be collected&#xD;
      at baseline, one-month (T1) and three-month (T2). SPSS version 23 and Generalized Estimating&#xD;
      equations (GEE) model will be employed to examine the effects of the LIP with MetS app&#xD;
      support.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Educational programme intervention on Lifestyle modification is recommended as the&#xD;
      primary intervention for metabolic syndrome (MetS), a cluster of cardio-metabolic risk&#xD;
      factors with a high prevalence rate globally and locally. Recent studies of lifestyle&#xD;
      intervention program (LIP) have been reported as effective on physical indicators and quality&#xD;
      of life (QoL) among MetS adult. However, they have the challenges in the delivery in making&#xD;
      care scalable and little is known about the effect on exercise outcomes such as total&#xD;
      exercise, cardiovascular endurance after exercise as well as whether the outcomes of this&#xD;
      programme can be applied in Hong Kong and improved by adding the mobile application.&#xD;
&#xD;
      Aims This Pilot study aims to develop and determine the feasibility and acceptability of a&#xD;
      mobile application (MetS app) together with a modified Life style modification Program (LIP)&#xD;
      for soon-to-aged adults with metabolic syndrome (MetS) and to determine the sample size for&#xD;
      the main RCT. .&#xD;
&#xD;
      Methods A prospective randomized control trial design with process evaluation will be&#xD;
      adopted. Inclusion criteria are those MetS participants, age 45 or above, able to use a smart&#xD;
      phone. A total of eighty eligible participants will be recruited from 2-3 community Centres.&#xD;
      Control group will receive standard care while intervention group will receive a MetS app.&#xD;
      Standard care consists of a modified three-month lifestyle modification booklet, a 30 minutes&#xD;
      educational session. The intervention group will receive a 30 minute education session plus&#xD;
      MetS support, which will be guided by health belief model to support an individual self-&#xD;
      monitoring and record of health measures (body weight, blood pressure, waist circumference)&#xD;
      and physical exercise (goal setting of exercise and record) across three months. All&#xD;
      information from the LIP booklet are also installed in the MetS platform as well. The primary&#xD;
      outcomes will be waist measure and the total physical exercise (GSLTPAQ). The secondary&#xD;
      outcomes included cardio-metabolic risk factors, cardiovascular endurance, self-efficacy for&#xD;
      exercise (SEE) and stress level (PSS-10) and quality of Life (SF12). Data will be collected&#xD;
      at baseline, one-month (T1) and three-month (T2). SPSS version 23 and Generalized Estimating&#xD;
      equations (GEE) model will be employed to examine the effects of the LIP with MetS app&#xD;
      support.&#xD;
&#xD;
      Significance This pilot study will provide insights to guide the main study. The findings&#xD;
      will facilitate the development of MetS app that could support the self-efficacy for physical&#xD;
      health monitoring and exercise of patients with MetS. Such programme may enhance patient's&#xD;
      self-management and monitoring of MetS, exercise behavior sustainability that will be&#xD;
      beneficial to reduced MetS risk profile, and improves psychological health and quality of&#xD;
      life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2018</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A multisite randomized controlled trial with two arms: MetS app group and , booklet group</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Randomisation and masking: A statistician will use computer-generated randomisation to determine random allocation. Eligible participants will be randomly allocated to either the control ( booklet group ) or the intervention group ( MetS app group) according to an allocation sequence prepared by the statistician before the start of the study. The patients will be randomised at a ratio of 1:1, with stratification by study site. Small cards indicating the group assignments will be placed in opaque sealed envelopes, which will be opened by the research assistant after each patient has completed the baseline questionnaires. In this study, the statisticians, outcome assessors and research assistant assigned to perform data input will be blinded to the allocation sequence. Given the type of intervention, however, the intervention group will be unmasked to the participants and the research nurse performing the intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>1 month and 3 months</time_frame>
    <description>body weight weighted at the same scale by the research assistant (RA) in the follow up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in total physical exercise</measure>
    <time_frame>baseline, 1 month and 3 months</time_frame>
    <description>Total physical exercise quantified with a modified version of the GSLTPAQ [31-32]. The patients were instructed to indicate the amount of exercises and to rank the exercises in the order of difficulty (strenuous, moderate, and mild). Total physical exercise will be computed by summing up the total number of sessions per week multiplied by minutes per session. The scale has been widely used in empirical studies and it has been shown to have good psychometric properties with acceptable test-retest reliability (ranged from 0.62 to 0.81), and correlated with maximum oxygen consumption, treadmill time and other similar physical activity questionnaire. [31-32].</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Chinese version of Self-Efficacy for Exercise (SEE-C)</measure>
    <time_frame>baseline, 1 month and 3 months</time_frame>
    <description>The SEE-C consists of nine items, and responses are made on a 0-10 scale. The sum of the responses to all nine items yields the final composite score ranging from 0-90. The C-SE has been proved to be reliable with good psychometric properties of Cronbach's alpha coefficient 0.75 for Taiwan Chinese older adults</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in Cardiovascular endurance test.</measure>
    <time_frame>baseline, 3 mobnths</time_frame>
    <description>it is a three -minute step test to test the cardiovascular functional endurance after exercise across the age span and gender. A participant step on and off of a 12 inch high bench / or stair for 3 minutes. Then pulse will be taken afterward while the participant remain standing. Compare the heart rate with the table according to the age and gender to determine the fitness in a range of 7 score from excellent, good, above average, average, below average, poor and very poor . Validity of this test has been established in previous studies. [35] .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Perceived stress scale (PSS-10)</measure>
    <time_frame>baseline, 1 month and 3 months</time_frame>
    <description>Ten self-report items measure the degree to which situations in one's life are appraised as stressful and the current levels of experienced stress in the last month. Summative scores range from 0 to 40, with a higher score indicating higher stress level. These scores have been used as outcome measures of experienced levels of stress. The psychometric properties of the Chinese version of PSS-10 were satisfactory with Cronbach's alphas &gt;0.75 in a local study for Chinese cardiac patients. [36]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization frequency</measure>
    <time_frame>baseline, 3 months</time_frame>
    <description>Recent hospitalization frequency (number of hospitalization visit and hospitalization in last three month) will be asked by Research assistant (RA) at baseline and at 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mets app usage frequency</measure>
    <time_frame>monthly till 3 month</time_frame>
    <description>MetS app usage (frequency per week) will be collected by RA by retrieving the data from the app server for the intervention group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Booklet usage frequency</measure>
    <time_frame>baseline, 1 month and 3 months</time_frame>
    <description>Booklet usage (frequency per week) will be collected for the control group at baseline, 1month and 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference (cm)</measure>
    <time_frame>baseline, 1 month and 3 months</time_frame>
    <description>The Waist circumference is measured by a trained RA with a tape (cm) at the midpoint between the top of the iliac crest and the lower margin of the last rib in the standing position at the end of several consecutive natural breaths. Data will be collected at baseline, 1month and 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure (mmHg)</measure>
    <time_frame>baseline, 1month and 3 months.</time_frame>
    <description>Systolic and diastolic blood pressure (mmHg) is measured by a trained RA using same equipment. Data will be collected at baseline, 1month and 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid level (mmol/L)</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>Lipid level: A drop of blood sample will be taken by using a finger stick to measure LDL cholesterol (mmol/L), and HDL cholesterol (mmol/L), and triglycerides (mmol/L). The data can be analysed immediately by using auto-analyser and the participants are asked to have 8 hours fasting. Data will be collected by RA at baseline, 1month and 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting blood glucose level (mmol/L)</measure>
    <time_frame>baseline, 1 month and 3 months</time_frame>
    <description>The participants are asked to have 8 hours fasting before blood taken. A drop of blood will be collected by finger stick by RA using same glucometer to measure the fasting blood glucose level at baseline, 1month and 3 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>mobile app</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mobile app: The participants will receive a Life style Modification Program with the support of mobile application (MetS app). The participants can view the similar knowledge content related to metabolic syndrome in their own smart phone. In addition, a membership area of the Mets 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 app installment and briefing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>booklet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants will receive the Life Style Modification programme with the support of a Hong Kong version Metabolic Syndrome (MetS) booklet to take home and use for 3 months. The booklet had been modified from a booklet of a Life Style Intervention Programme (LIP) in China and the principal investigator of this proposal was the core team members of the previous project . 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 . The major component of the booklet for the change is the language translated from simplified Chinese to traditional Chinese and slight adjustment about the advice on vegetable choice due to difference in type of available vegetables in Hong Kong.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mobile application</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>booklet</arm_group_label>
    <arm_group_label>mobile app</arm_group_label>
    <other_name>Booklet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who satisfy the inclusion and exclusion criteria will be invited to&#xD;
             participate in the RCT. The inclusion criteria are those :&#xD;
&#xD;
               1. Ethnic Chinese Client who has a smart phone.&#xD;
&#xD;
               2. Adult age 45 or over&#xD;
&#xD;
               3. MetS Clients [1] with central obesity (male &gt;90 cm , female &gt; 80cm ) plus two&#xD;
                  items of the followings :&#xD;
&#xD;
                    -  Raised triglycerides ≥ 150 mg/dL (1.7 mmol/L) or specific treatment for this&#xD;
                       lipid abnormality&#xD;
&#xD;
                    -  Reduced HDL cholesterol &lt; 40 mg/dL (1.03 mmol/L) in males &lt; 50 mg/dL (1.29&#xD;
                       mmol/L) in females or treatment for this lipid abnormality&#xD;
&#xD;
                    -  Raised blood pressure systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg or&#xD;
                       treatment of previously diagnosed hypertension (HT)&#xD;
&#xD;
                    -  Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously&#xD;
                       diagnosed type 2 diabetes (DM)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clients with physical, mental, visual, or cognitive impairments with regular medical&#xD;
             follow-ups and treatment, and those who have musculoskeletal disorders or other&#xD;
             disabling diseases that may limit the practice of walking exercise will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eliza ML Wong, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sai Kung community centre</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>August 5, 2019</last_update_submitted>
  <last_update_submitted_qc>August 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Dr Eliza Wong</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>life style modification program</keyword>
  <keyword>mobile application</keyword>
  <keyword>metabolic sydrome</keyword>
  <keyword>booklet</keyword>
  <keyword>RCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The result will be published .</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03762434
org study id: 1-BE0N
nct id: NCT03762434
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A multisite randomized controlled trial with two arms: MetS app group and , booklet group
primary purpose: Supportive Care
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
masking description: Randomisation and masking: A statistician will use computer-generated randomisation to determine random allocation. Eligible participants will be randomly allocated to either the control ( booklet group ) or the intervention group ( MetS app group) according to an allocation sequence prepared by the statistician before the start of the study. The patients will be randomised at a ratio of 1:1, with stratification by study site. Small cards indicating the group assignments will be placed in opaque sealed envelopes, which will be opened by the research assistant after each patient has completed the baseline questionnaires. In this study, the statisticians, outcome assessors and research assistant assigned to perform data input will be blinded to the allocation sequence. Given the type of intervention, however, the intervention group will be unmasked to the participants and the research nurse performing the intervention.
measure: Change in body weight
time frame: 1 month and 3 months
description: body weight weighted at the same scale by the research assistant (RA) in the follow up
measure: Change in total physical exercise
time frame: baseline, 1 month and 3 months
description: Total physical exercise quantified with a modified version of the GSLTPAQ [31-32]. The patients were instructed to indicate the amount of exercises and to rank the exercises in the order of difficulty (strenuous, moderate, and mild). Total physical exercise will be computed by summing up the total number of sessions per week multiplied by minutes per session. The scale has been widely used in empirical studies and it has been shown to have good psychometric properties with acceptable test-retest reliability (ranged from 0.62 to 0.81), and correlated with maximum oxygen consumption, treadmill time and other similar physical activity questionnaire. [31-32].
measure: Change in Chinese version of Self-Efficacy for Exercise (SEE-C)
time frame: baseline, 1 month and 3 months
description: The SEE-C consists of nine items, and responses are made on a 0-10 scale. The sum of the responses to all nine items yields the final composite score ranging from 0-90. The C-SE has been proved to be reliable with good psychometric properties of Cronbach's alpha coefficient 0.75 for Taiwan Chinese older adults
measure: change in Cardiovascular endurance test.
time frame: baseline, 3 mobnths
description: it is a three -minute step test to test the cardiovascular functional endurance after exercise across the age span and gender. A participant step on and off of a 12 inch high bench / or stair for 3 minutes. Then pulse will be taken afterward while the participant remain standing. Compare the heart rate with the table according to the age and gender to determine the fitness in a range of 7 score from excellent, good, above average, average, below average, poor and very poor . Validity of this test has been established in previous studies. [35] .
measure: Change in Perceived stress scale (PSS-10)
time frame: baseline, 1 month and 3 months
description: Ten self-report items measure the degree to which situations in one's life are appraised as stressful and the current levels of experienced stress in the last month. Summative scores range from 0 to 40, with a higher score indicating higher stress level. These scores have been used as outcome measures of experienced levels of stress. The psychometric properties of the Chinese version of PSS-10 were satisfactory with Cronbach's alphas >0.75 in a local study for Chinese cardiac patients. [36]
measure: Hospitalization frequency
time frame: baseline, 3 months
description: Recent hospitalization frequency (number of hospitalization visit and hospitalization in last three month) will be asked by Research assistant (RA) at baseline and at 3 months.
measure: Mets app usage frequency
time frame: monthly till 3 month
description: MetS app usage (frequency per week) will be collected by RA by retrieving the data from the app server for the intervention group
measure: Booklet usage frequency
time frame: baseline, 1 month and 3 months
description: Booklet usage (frequency per week) will be collected for the control group at baseline, 1month and 3 months.
measure: Waist circumference (cm)
time frame: baseline, 1 month and 3 months
description: The Waist circumference is measured by a trained RA with a tape (cm) at the midpoint between the top of the iliac crest and the lower margin of the last rib in the standing position at the end of several consecutive natural breaths. Data will be collected at baseline, 1month and 3 months.
measure: Blood pressure (mmHg)
time frame: baseline, 1month and 3 months.
description: Systolic and diastolic blood pressure (mmHg) is measured by a trained RA using same equipment. Data will be collected at baseline, 1month and 3 months.
measure: Lipid level (mmol/L)
time frame: baseline and 3 months
description: Lipid level: A drop of blood sample will be taken by using a finger stick to measure LDL cholesterol (mmol/L), and HDL cholesterol (mmol/L), and triglycerides (mmol/L). The data can be analysed immediately by using auto-analyser and the participants are asked to have 8 hours fasting. Data will be collected by RA at baseline, 1month and 3 months.
measure: Fasting blood glucose level (mmol/L)
time frame: baseline, 1 month and 3 months
description: The participants are asked to have 8 hours fasting before blood taken. A drop of blood will be collected by finger stick by RA using same glucometer to measure the fasting blood glucose level at baseline, 1month and 3 months.
arm group label: mobile app
arm group type: Active Comparator
description: Mobile app: The participants will receive a Life style Modification Program with the support of mobile application (MetS app). The participants can view the similar knowledge content related to metabolic syndrome in their own smart phone. In addition, a membership area of the Mets 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 app installment and briefing.
arm group label: booklet
arm group type: Active Comparator
description: The participants will receive the Life Style Modification programme with the support of a Hong Kong version Metabolic Syndrome (MetS) booklet to take home and use for 3 months. The booklet had been modified from a booklet of a Life Style Intervention Programme (LIP) in China and the principal investigator of this proposal was the core team members of the previous project . 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 . The major component of the booklet for the change is the language translated from simplified Chinese to traditional Chinese and slight adjustment about the advice on vegetable choice due to difference in type of available vegetables in Hong Kong.
intervention type: Other
intervention name: mobile application
description: 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.
arm group label: booklet
arm group label: mobile app
other name: Booklet
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
last name: Eliza ML Wong, PhD
role: Principal Investigator
affiliation: The Hong Kong Polytechnic University
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Dr Eliza Wong
investigator title: Assistant Professor
mesh term: Metabolic Syndrome
mesh term: Syndrome
sharing ipd: Undecided
ipd description: The result will be published .