- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02937987
Dietary Intake, Eating Behavior, Physical Activity Level and Their Relationships With Glycemic and Weight Control in Hong Kong Chinese Type 2 Diabetic Patients
January 29, 2019 updated by: Lorena Tsui Fun Cheung, Chinese University of Hong Kong
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
211
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Hong Kong Chinese T2DM patients referred to the Prince of Wales Hospital (PWH) diabetes centre
Description
Inclusion Criteria:
- Male or female of Chinese ethnicity
- Diagnosis of T2DM
- Able to read Chinese and give informed written consents
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Group 1
non-obese type 2 DM
|
Group 2
obese type 2 DM
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of HbA1c
Time Frame: 1 year
|
1 year
|
Change of Weight
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
October 17, 2016
First Submitted That Met QC Criteria
October 17, 2016
First Posted (Estimate)
October 19, 2016
Study Record Updates
Last Update Posted (Actual)
January 31, 2019
Last Update Submitted That Met QC Criteria
January 29, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lifestyle-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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