a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adults With Metabolic Syndrome

The Hong Kong Polytechnic University264 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

264

Conditions

Metabolic Syndrome

Interventions

App groupOTHER

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 groupOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Ethnic Chinese client who has a smart phone. 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: * 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.

Locations (1)

Wan chai Methodist Centre for the Seniors

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

Body weight

change in body weight will be measured at the same scale in the follow up centre

Time frame: 24 weeks

Secondary Outcomes

Total physical exercise

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 \[31-32\]

Time frame: 24 weeks

Chinese version of Self-Efficacy for Exercise (SEE-C)

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 \[33-34\].

Time frame: 24 weeks

Cardiovascular endurance test.

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. \[35\] .

Time frame: 24 weeks

Perceived stress scale (PSS-10)

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. \[36\]

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.