a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adults With Metabolic Syndrome
2022年4月1日 更新者：Dr Eliza Wong、The Hong Kong Polytechnic University
A Multicentre Randomized Controlled Trial of the Effectiveness of a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adults With Metabolic Syndrome
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
264
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Hong Kong、香港、00
- Wan chai Methodist Centre for the Seniors
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～99年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Ethnic Chinese client who has a smart phone.
- Adult age 18 or over
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)
- Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes (DM) -
Exclusion Criteria:
- Clients with physical, mental, visual, or cognitive impairments with regular medical follow-ups and treatment, and those who have musculoskeletal disorders or other disabling diseases that may limit the practice of walking exercise will be excluded. Client receiving prescription of medication for weight reduction will be excluded as well.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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.
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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.
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アクティブコンパレータ：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.
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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.
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アクティブコンパレータ：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Body weight
時間枠：24 weeks
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change in body weight will be measured at the same scale in the follow up centre
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24 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Total physical exercise
時間枠：24 weeks
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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]
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24 weeks
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Chinese version of Self-Efficacy for Exercise (SEE-C)
時間枠：24 weeks
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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].
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24 weeks
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Cardiovascular endurance test.
時間枠：24 weeks
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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] .
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24 weeks
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Perceived stress scale (PSS-10)
時間枠：24 weeks
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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]
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24 weeks
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hospitalization
時間枠：24 weeks
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hospitalization frequency will be asked
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24 weeks
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app usage
時間枠：24 weeks
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MetS app usage (frequency per week) will be collected by RA by retrieving the data from the app server for the intervention group monthly.
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24 weeks
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booklet usage
時間枠：24 weeks
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Booklet usage (frequency per week) will be collected for the control group at baseline, week 4,12 and 24
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24 weeks
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Waist circumference (cm)
時間枠：24 weeks
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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
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24 weeks
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blood pressure
時間枠：24 weeks
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Systolic and diastolic blood pressure (mmHg) is measured by a trained RA using same equipment.
Data will be collected by RA
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24 weeks
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Lipid level
時間枠：24 weeks
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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
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24 weeks
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Fasting blood glucose
時間枠：24 weeks
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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
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24 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Eliza ML Wong、HKPolyu
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年8月1日
一次修了 (実際)
2021年12月1日
研究の完了 (実際)
2022年1月2日
試験登録日
最初に提出
2018年12月11日
QC基準を満たした最初の提出物
2018年12月15日
最初の投稿 (実際)
2018年12月19日
学習記録の更新
投稿された最後の更新 (実際)
2022年4月4日
QC基準を満たした最後の更新が送信されました
2022年4月1日
最終確認日
2022年4月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- HSEARS20181211005
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いいえ
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