Clinical trial NCT03778788: a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adults With Metabolic Syndrome
Official title: A Multicentre Randomized Controlled Trial of the Effectiveness of a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adults With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: life style modification program
mobile application
booklet
exercise
body weight
randomized control trial
metabolic syndrome
adult
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multisite randomized controlled trial with three arms : app group, booklet and leaflet
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body weight
timeFrame: 24 weeks
Secondary outcomes:
measure: Total physical exercise
timeFrame: 24 weeks
measure: Chinese version of Self-Efficacy for Exercise (SEE-C)
timeFrame: 24 weeks
measure: Cardiovascular endurance test.
timeFrame: 24 weeks
measure: Perceived stress scale (PSS-10)
timeFrame: 24 weeks
measure: hospitalization
timeFrame: 24 weeks
measure: app usage
timeFrame: 24 weeks
measure: booklet usage
timeFrame: 24 weeks
measure: Waist circumference (cm)
timeFrame: 24 weeks
measure: blood pressure
timeFrame: 24 weeks
measure: Lipid level
timeFrame: 24 weeks
measure: Fasting blood glucose
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Wan chai Methodist Centre for the Seniors
Study officials:
affiliation: HKPolyu
name: Eliza ML Wong
role: PRINCIPAL_INVESTIGATOR
References: