NCT03778788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2022

Completed
Last Updated

April 4, 2022

Status Verified

April 1, 2022

Enrollment Period

2.3 years

First QC Date

December 11, 2018

Last Update Submit

April 1, 2022

Conditions

Metabolic Syndrome

Keywords

life style modification programmobile applicationbookletexercisebody weightrandomized control trialmetabolic syndromeadult

Outcome Measures

Primary Outcomes (1)

  • Body weight

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

    24 weeks

Secondary Outcomes (11)

  • Total physical exercise

    24 weeks

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

    24 weeks

  • Cardiovascular endurance test.

    24 weeks

  • Perceived stress scale (PSS-10)

    24 weeks

  • hospitalization

    24 weeks

  • +6 more secondary outcomes

Study Arms (3)

App group

ACTIVE COMPARATOR

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.

Other: App group

Booklet group

ACTIVE COMPARATOR

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.

Other: Booklet group

control group

ACTIVE COMPARATOR

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.

Other: Booklet groupOther: control group

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.

App group
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.

Booklet groupcontrol group
control groupOTHER

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.

control group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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) -

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wan chai Methodist Centre for the Seniors

Hong Kong, 00, Hong Kong

Location

Related Publications (1)

  • Wong EML, Tam HL, Leung AYM, Cheung ASP, Cheung KC, Leung DYP. Impacts of Educational Interventions with Support of Mobile App versus Booklet for Patients with Hypertension and Metabolic Syndrome: A Secondary Data Analysis. Int J Environ Res Public Health. 2022 Oct 2;19(19):12591. doi: 10.3390/ijerph191912591.

    PMID: 36231891DERIVED

MeSH Terms

Conditions

Metabolic SyndromeMotor ActivityBody Weight

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Eliza ML Wong

    HKPolyu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A computer-generated randomizer will be used to decide the random allocation. Each eligible subject will be assigned a number generated by the computer. By using random numbers, subjects will be randomly allocated to different groups. This randomization ensure equal sample size in the study groups.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A multisite randomized controlled trial with three arms : app group, booklet and leaflet
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Research Fellow

Study Record Dates

First Submitted

December 11, 2018

First Posted

December 19, 2018

Study Start

August 1, 2019

Primary Completion

December 1, 2021

Study Completion

January 2, 2022

Last Updated

April 4, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)