<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/NCT03778788</url>
  </required_header>
  <id_info>
    <org_study_id>HSEARS20181211005</org_study_id>
    <nct_id>NCT03778788</nct_id>
  </id_info>
  <brief_title>a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adults With Metabolic Syndrome</brief_title>
  <official_title>A Multicentre Randomized Controlled Trial of the Effectiveness of a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adults With Metabolic Syndrome</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>No</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>
      The study aims to compare the effect of a lifestyle intervention programme (LIP) using mobile&#xD;
      application (MetS app) vs using booklet for MetS adults living in the community.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to compare the effect of a lifestyle intervention programme (LIP) using mobile&#xD;
      application (MetS app) vs using booklet for MetS adults living in the community.&#xD;
&#xD;
      Methods A multi-site randomized controlled trial (RCT) with three arms, namely, MetS app&#xD;
      group (Group A), booklet group (Group B), and control group (group C). Three hundred and&#xD;
      sixty subjects will be recruited from six community centers and randomized into either one&#xD;
      arm. Inclusion criteria are those MetS adult, able to use a smart phone. Group a participants&#xD;
      will receive a 30-minute educational session and a MetS app while Group B will receive same&#xD;
      educational session and a MetS booklet and the control group receive a placebo booklet only.&#xD;
      The MetS app or booklet, has been well developed by the team with the support of internal&#xD;
      grant, aims to support MetS individual's self- monitoring and record of health measures (body&#xD;
      weight, blood pressure, waist circumference) and exercise. The primary outcomes of this study&#xD;
      include the body weight and total physical exercise (GSLTPAQ). The secondary outcomes include&#xD;
      cardiometabolic risk factors, cardiovascular endurance, self-efficacy for exercise (SEE) and&#xD;
      stress level (PSS-10). Data will be collected at baseline (T1), 4 week (T2) and week 12 (T3)&#xD;
      and week 24 (T4). SPSS and Generalized Estimating equations (GEE) model will be employed for&#xD;
      data analysis.&#xD;
&#xD;
      Significance This study will provide empirical evidence and inform about the effective way to&#xD;
      enhance patient's self-management of MetS, exercise sustainability that will be beneficial to&#xD;
      clients' health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Actual">January 2, 2022</completion_date>
  <primary_completion_date type="Actual">December 1, 2021</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 three arms : app group, booklet and leaflet</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>A computer-generated randomizer will be used to decide the random allocation. Each eligible subject will be assigned a number generated by the computer. By using random numbers, subjects will be randomly allocated to different groups. This randomization ensure equal sample size in the study groups.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Body weight</measure>
    <time_frame>24 weeks</time_frame>
    <description>change in body weight will be measured at the same scale in the follow up centre</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total physical exercise</measure>
    <time_frame>24 weeks</time_frame>
    <description>Total physical exercise will be quantified with a modified version of the GSLTPAQ [31-32]. The patients will be instructed to indicate the amount of exercises undertaken and rank the exercises in the order of difficulty (strenuous, moderate, or mild). The total score will be calculated. This measure has been widely used in empirical studies and shown to exhibit good Psychometric properties [31-32]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chinese version of Self-Efficacy for Exercise (SEE-C)</measure>
    <time_frame>24 weeks</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 [33-34].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular endurance test.</measure>
    <time_frame>24 weeks</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>Perceived stress scale (PSS-10)</measure>
    <time_frame>24 weeks</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</measure>
    <time_frame>24 weeks</time_frame>
    <description>hospitalization frequency will be asked</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>app usage</measure>
    <time_frame>24 weeks</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 monthly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>booklet usage</measure>
    <time_frame>24 weeks</time_frame>
    <description>Booklet usage (frequency per week) will be collected for the control group at baseline, week 4,12 and 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference (cm)</measure>
    <time_frame>24 weeks</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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>24 weeks</time_frame>
    <description>Systolic and diastolic blood pressure (mmHg) is measured by a trained RA using same equipment. Data will be collected by RA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid level</measure>
    <time_frame>24 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting blood glucose</measure>
    <time_frame>24 weeks</time_frame>
    <description>Fasting blood glucose level (mmol/L) : 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</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">264</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>App group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive the MetS mobile application (MetS app) instalment and briefing by a research assistant (RA2) after the educational talk. They will be able view the booklet content in their own smart phone. In addition, a membership area provides individual support of self- health monitoring, goal setting for their exercise plan and exercise record.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Booklet group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants will additionally receive a Hong Kong version Lifestyle Intervention Programme (LIP) booklet to take home and use for 20 weeks. The major component of the LIP booklet consists of fact of metabolic syndrome, advise of diet, exercise, medication, life style and stress management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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 20 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>App group</intervention_name>
    <description>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.</description>
    <arm_group_label>App group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Booklet group</intervention_name>
    <description>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.</description>
    <arm_group_label>Booklet group</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control group</intervention_name>
    <description>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.</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ethnic Chinese client who has a smart phone.&#xD;
&#xD;
          2. Adult age 18 or over&#xD;
&#xD;
          3. MetS Clients with central obesity (male &gt;90 cm , female &gt; 80cm ) plus two items of the&#xD;
             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 treatment&#xD;
                  of previously diagnosed hypertension (HT)&#xD;
&#xD;
          4. Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed&#xD;
             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;
             Client receiving prescription of medication for weight reduction will be excluded as&#xD;
             well.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eliza ML Wong</last_name>
    <role>Principal Investigator</role>
    <affiliation>HKPolyu</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wan chai Methodist Centre for the Seniors</name>
      <address>
        <city>Hong Kong</city>
        <zip>00</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 15, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>April 1, 2022</last_update_submitted>
  <last_update_submitted_qc>April 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2022</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>Principal Research Fellow</investigator_title>
  </responsible_party>
  <keyword>life style modification program</keyword>
  <keyword>mobile application</keyword>
  <keyword>booklet</keyword>
  <keyword>exercise</keyword>
  <keyword>body weight</keyword>
  <keyword>randomized control trial</keyword>
  <keyword>metabolic syndrome</keyword>
  <keyword>adult</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>No</sharing_ipd>
  </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/NCT03778788
org study id: HSEARS20181211005
nct id: NCT03778788
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A multisite randomized controlled trial with three arms : app group, booklet and leaflet
primary purpose: Supportive Care
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
masking description: A computer-generated randomizer will be used to decide the random allocation. Each eligible subject will be assigned a number generated by the computer. By using random numbers, subjects will be randomly allocated to different groups. This randomization ensure equal sample size in the study groups.
measure: Body weight
time frame: 24 weeks
description: change in body weight will be measured at the same scale in the follow up centre
measure: Total physical exercise
time frame: 24 weeks
description: Total physical exercise will be quantified with a modified version of the GSLTPAQ [31-32]. The patients will be instructed to indicate the amount of exercises undertaken and rank the exercises in the order of difficulty (strenuous, moderate, or mild). The total score will be calculated. This measure has been widely used in empirical studies and shown to exhibit good Psychometric properties [31-32]
measure: Chinese version of Self-Efficacy for Exercise (SEE-C)
time frame: 24 weeks
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 [33-34].
measure: Cardiovascular endurance test.
time frame: 24 weeks
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: Perceived stress scale (PSS-10)
time frame: 24 weeks
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
time frame: 24 weeks
description: hospitalization frequency will be asked
measure: app usage
time frame: 24 weeks
description: MetS app usage (frequency per week) will be collected by RA by retrieving the data from the app server for the intervention group monthly.
measure: booklet usage
time frame: 24 weeks
description: Booklet usage (frequency per week) will be collected for the control group at baseline, week 4,12 and 24
measure: Waist circumference (cm)
time frame: 24 weeks
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
measure: blood pressure
time frame: 24 weeks
description: Systolic and diastolic blood pressure (mmHg) is measured by a trained RA using same equipment. Data will be collected by RA
measure: Lipid level
time frame: 24 weeks
description: 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
measure: Fasting blood glucose
time frame: 24 weeks
description: Fasting blood glucose level (mmol/L) : 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
arm group label: App group
arm group type: Active Comparator
description: Participants will receive the MetS mobile application (MetS app) instalment and briefing by a research assistant (RA2) after the educational talk. They will be able view the booklet content in their own smart phone. In addition, a membership area provides individual support of self- health monitoring, goal setting for their exercise plan and exercise record.
arm group label: Booklet group
arm group type: Active Comparator
description: The participants will additionally receive a Hong Kong version Lifestyle Intervention Programme (LIP) booklet to take home and use for 20 weeks. The major component of the LIP booklet consists of fact of metabolic syndrome, advise of diet, exercise, medication, life style and stress management.
arm group label: control group
arm group type: Active Comparator
description: 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 20 weeks.
intervention type: Other
intervention name: App group
description: 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.
arm group label: App group
intervention type: Other
intervention name: Booklet group
description: 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.
arm group label: Booklet group
arm group label: control group
intervention type: Other
intervention name: control group
description: 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.
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Eliza ML Wong
role: Principal Investigator
affiliation: HKPolyu
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Dr Eliza Wong
investigator title: Principal Research Fellow
mesh term: Metabolic Syndrome
mesh term: Syndrome
sharing ipd: No