Brief Intervention to Promote Smoking Cessation in DM Smokers

NCT02875782 | Completed DMC

• 1 other identifier: DM-rct
• Study Type: interventional
• Target: 557
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 2.the changes in levels of HbA1c between (a) the intervention group and the controls, and (b) quitters and continuing smokers;
3. 3.the predictive factors for the success of the outcomes above.

Conditions

Smoking

Keywords

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Self-reported 7-day point-prevalence smoking abstinence

  12 months

Secondary Outcomes (5)

• Blood HbA1c level

  12 months

• biochemically validated abstinence using exhaled CO test

  12 months

• Self-reported reduction of ≥ 50% in cigarette consumption

  12 months

• Self-reported progress in the stage of readiness to quit

  12 months

• Self-reported quit attempt numbers over the past 12 months.

  12 months

Study Arms (2)

DM intervention

EXPERIMENTAL

Subjects will receive a patient-centered motivational intervention with two components: (1) the stage-matched smoking cessation intervention and (2) the relationship between smoking and diabetic complications. All subjects will receive a self-help cessation manual with DM components and take the exhaled carbon monoxide test. The total counseling process will take about 20 minutes. Three consecutive (3-, 6- and 12-month) follow ups will be conducted. Also, the counselor will further the progress of their action plan and barriers encountered in the behavioral change process as well as engage them in the process, enhance their self-efficacy, and identify individual barriers and facilitators.

Behavioral: Smoking cessation and DM specific component intervention

Control group

PLACEBO COMPARATOR

Subjects will receive usual care provided at the DM clinic. All subjects will receive a self-help cessation manual and take the exhaled carbon monoxide test. Counselor will give follow-up calls to the patients to assess their smoking status and other health-related lifestyle practices. Three consecutive (3-, 6- and 12-month) follow ups will be conducted with all participants. The total counseling process will take about 20 minutes.

Behavioral: Control group

Interventions

Smoking cessation and DM specific component intervention BEHAVIORAL

A brief stage-matched smoking cessation intervention plus a DM-specific leaflet on smoking cessation

DM intervention

Control group BEHAVIORAL

A simple, brief advice and a self-help general leaflet on smoking cessation

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• William Ho Cheung LI, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 23, 2016
• Study Start: January 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 23, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share