NCT02937987

Brief Summary

The objective of this study is to describe and examine the dietary intake, eating behavior and physical activity level of a cohort of Hong Kong Chinese with T2DM and their association with weight and glycemic control at baseline and 1 year follow-up. The investigators hypothesize that Hong Kong Chinese T2DM patients with unhealthy dietary intake and pattern and low physical activity level are associated with poorer glycemic and weight control, and there will be no improvement with weight and glycemic control under usual care after 1 year.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
211

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1.9 years

First QC Date

October 17, 2016

Last Update Submit

January 29, 2019

Conditions

Type 2 Diabetes Mellitus in Obese

Outcome Measures

Primary Outcomes (2)

  • Change of HbA1c

    1 year

  • Change of Weight

    1 year

Study Arms (2)

Group 1

non-obese type 2 DM

Group 2

obese type 2 DM

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hong Kong Chinese T2DM patients referred to the Prince of Wales Hospital (PWH) diabetes centre

You may qualify if:

  • Male or female of Chinese ethnicity
  • Diagnosis of T2DM
  • Able to read Chinese and give informed written consents

You may not qualify if:

  • Type 1 diabetes mellitus
  • End-stage renal failure requiring dialysis or chronic kidney disease (CKD) stage 4 or above
  • Malignancy diagnosed within 3 years
  • Pregnancy or lactation
  • Any medical illness or condition as judged by the investigators as ineligible to participate the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student in medical science

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 19, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

January 31, 2019

Record last verified: 2019-01