Smoking Clinical Trial
Official title:
Brief Intervention to Promote Smoking Cessation and Improve Glycemic Control in DM Smokers With Type 2 Diabetes: a Randomized Controlled Trial
Verified date | August 2016 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | Hong Kong: Ethics Committee |
Study type | Interventional |
The study is a randomized controlled trial (RCT) on a tailored smoking cessation
intervention targeted type 2 diabetic patients who smoke (DM intervention). The objectives
are:
1. to study the effectiveness of the DM intervention in achieving (a) smoking cessation,
(b) smoking reduction, and (c) progress to a higher stage of readiness to quit;
2. the changes in levels of HbA1c between (a) the intervention group and the controls, and
(b) quitters and continuing smokers;
3. the predictive factors for the success of the outcomes above.
Status | Completed |
Enrollment | 557 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Smokers - who are at least 2 cigarettes daily in the past 30 days, - who are diagnosed with type 2 diabetes for at least 6 months such that their diabetic conditions and treatments should be stable, - who are age 18 or above, and - who can communicate in Cantonese; Exclusion Criteria: Smokers - who are too sick to receive intervention, - who are poor cognitive state (People with poor cognitive state refers to those with poor cognitive function and unable to communicate logically), - who are mental illness, - who is undergoing other smoking cessation program, and - with unstable diabetic (i.e. those with poor diabetes condition that needed hospitalization) or other medical conditions deemed to be not suitable by the doctor in charge. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-reported 7-day point-prevalence smoking abstinence | 12 months | No | |
Secondary | Blood HbA1c level | 12 months | No | |
Secondary | biochemically validated abstinence using exhaled CO test | 12 months | No | |
Secondary | Self-reported reduction of = 50% in cigarette consumption | 12 months | No | |
Secondary | Self-reported progress in the stage of readiness to quit | 12 months | No | |
Secondary | Self-reported quit attempt numbers over the past 12 months. | 12 months | No |
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