a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adults With Metabolic Syndrome
NCT ID: NCT03778788
Last Updated: 2022-04-04
Study Results
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Basic Information
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COMPLETED
NA
264 participants
INTERVENTIONAL
2019-08-01
2022-01-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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App group
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.
App group
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.
Booklet group
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.
Booklet group
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.
control group
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.
Booklet group
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.
control group
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.
Interventions
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App group
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.
Booklet group
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.
control group
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.
Eligibility Criteria
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Inclusion Criteria
2. Adult age 18 or over
3. 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)
4. Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes (DM) -
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Responsible Party
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Dr Eliza Wong
Principal Research Fellow
Principal Investigators
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Eliza ML Wong
Role: PRINCIPAL_INVESTIGATOR
HKPolyu
Locations
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Wan chai Methodist Centre for the Seniors
Hong Kong, , Hong Kong
Countries
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References
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Wong EML, Tam HL, Leung AYM, Cheung ASP, Cheung KC, Leung DYP. Impacts of Educational Interventions with Support of Mobile App versus Booklet for Patients with Hypertension and Metabolic Syndrome: A Secondary Data Analysis. Int J Environ Res Public Health. 2022 Oct 2;19(19):12591. doi: 10.3390/ijerph191912591.
Other Identifiers
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HSEARS20181211005
Identifier Type: -
Identifier Source: org_study_id
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