a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adults With Metabolic Syndrome
2022년 4월 1일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
264
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Hong Kong, 홍콩, 00
- Wan chai Methodist Centre for the Seniors
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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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활성 비교기: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Body weight
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Total physical exercise
기간: 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)
기간: 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.
기간: 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)
기간: 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
기간: 24 weeks
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hospitalization frequency will be asked
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24 weeks
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app usage
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Eliza ML Wong, HKPolyu
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 8월 1일
기본 완료 (실제)
2021년 12월 1일
연구 완료 (실제)
2022년 1월 2일
연구 등록 날짜
최초 제출
2018년 12월 11일
QC 기준을 충족하는 최초 제출
2018년 12월 15일
처음 게시됨 (실제)
2018년 12월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 4월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 4월 1일
마지막으로 확인됨
2022년 4월 1일
추가 정보
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