Status:

UNKNOWN

Study Protocol of the EMPOWER-SUSTAIN Project

Lead Sponsor:

Universiti Teknologi Mara

Collaborating Sponsors:

Ministry of Education, Malaysia

Conditions:

Metabolic Syndrome

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief Summary

A pilot randomised controlled trial will be conducted in UiTM Primary Care Clinic, Selayang Campus, Selangor, Malaysia. A total of 232 patients with Metabolic Syndrome (MetS) will be recruited; 116 wi...

Detailed Description

Study Design: This is a pilot randomised controlled trial. The overall duration of the study is one year, and the duration of the intervention is 6 months. Blinding is not possible due to the nature ...

Eligibility Criteria

Inclusion

  • diagnosed with MetS according to the JIS definition
  • have received follow-up care for MetS at the university primary care clinic at least twice in the last one year
  • have regular access to the internet
  • perceive that they have basic skills to use the web and smart mobile phone
  • are able to read and understand written English or Malay

Exclusion

  • type 1 diabetes mellitus
  • receiving renal dialysis
  • resented with severe hypertension (Systolic BP \> 180 mmHg and/or Diastolic BP \> 110 mmHg) at recruitment
  • diagnosed with conditions resulting in secondary hypertension
  • diagnosed with circulatory disorders requiring referral to secondary care over the last one year and during the course of the study
  • receiving shared care at primary and secondary care centres for cardiovascular diseases
  • receiving chemotherapy/ radiotherapy or palliative care
  • diagnosed with a psychiatric illness such as schizophrenia, bipolar disorder, major depression
  • diagnosed with cognitive impairment such as dementia
  • pregnant
  • enrolled in another intervention study

Key Trial Info

Start Date :

March 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2022

Estimated Enrollment :

232 Patients enrolled

Trial Details

Trial ID

NCT04120779

Start Date

March 1 2021

End Date

December 31 2022

Last Update

November 23 2020

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Study Protocol of the EMPOWER-SUSTAIN Project | DecenTrialz