The Effectiveness of a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adult With Metabolic Syndrome _ a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change in body weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who satisfy the inclusion and exclusion criteria will be invited to participate in the RCT. The inclusion criteria are those :
- •Ethnic Chinese Client who has a smart phone.
- •Adult age 45 or over
- •MetS Clients [1] 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)
排除标准
- •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.
研究组 & 干预措施
mobile app
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.
干预措施: mobile application (Other)
booklet
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.
干预措施: mobile application (Other)
结局指标
主要结局
Change in body weight
时间窗: 1 month and 3 months
body weight weighted at the same scale by the research assistant (RA) in the follow up
Change in total physical exercise
时间窗: baseline, 1 month and 3 months
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. \[31-32\].
次要结局
- Mets app usage frequency(monthly till 3 month)
- Lipid level (mmol/L)(baseline and 3 months)
- Change in Perceived stress scale (PSS-10)(baseline, 1 month and 3 months)
- Booklet usage frequency(baseline, 1 month and 3 months)
- Change in Chinese version of Self-Efficacy for Exercise (SEE-C)(baseline, 1 month and 3 months)
- Waist circumference (cm)(baseline, 1 month and 3 months)
- Hospitalization frequency(baseline, 3 months)
- change in Cardiovascular endurance test.(baseline, 3 mobnths)
- Blood pressure (mmHg)(baseline, 1month and 3 months.)
- Fasting blood glucose level (mmol/L)(baseline, 1 month and 3 months)
研究者
Dr Eliza Wong
Assistant Professor
The Hong Kong Polytechnic University