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

The Hong Kong Polytechnic University

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Other: Booklet group; Other: control group; Other: App group

Study type: Interventional

Funder types: Other

Identifiers

NCT03778788

HSEARS20181211005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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264 participants in 3 patient groups

App group

Active Comparator group

Description:

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.

Treatment:

Other: App group

Booklet group

Active Comparator group

Description:

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.

Treatment:

Other: Booklet group

control group

Active Comparator group

Description:

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.

Treatment:

Other: Booklet group

Other: control group