The 5 A’s model in behavioural therapy versus brief advice on smoking cessation delivered by dentists in a dental setting

• Register: ISRCTN
• Last refreshed on: 11 February 2019
• Main ID: ISRCTN16325841
• Date of registration: 19/01/2016
• Prospective Registration: No
• Primary sponsor: University of Malaya
• Public title: The 5 A’s model in behavioural therapy versus brief advice on smoking cessation delivered by dentists in a dental setting
• Scientific title: The 5 A’s model in behavioural therapy versus brief advice on smoking cessation delivered by dentists in a dental setting: a randomized controlled trial
• Date of first enrolment: 10/03/2014
• Target sample size: 500
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN16325841
• Study type: Interventional
• Study design: Two-arm single-blinded randomized controlled trial (parallel design) (Prevention)

Countries of recruitment

Malaysia

Contacts

• Name: Nurul Asyikin Yahya

Key inclusion & exclusion criteria

Inclusion criteria:
1. Smokers attending Ministry of Health Dental Clinics in Selango
2. A Malaysian citizen
3. Aged between 15-70 years
4. Smoke at least for the past 30 days
5. Are contactable by telephone
6. Is not currently under smoking cessation treatment with other health clinic

Exclusion criteria:
1. Not a smoker
2. Not a Malaysian citizen
3. Not contactable by telephone


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Smoking
Mental and Behavioural Disorders

Intervention(s)

A two-arm single-blinded randomized controlled trial (parallel design) will be conducted to compare the effectiveness of the 5A’s smoking cessation intervention (5A’s) versus a brief advice (BA) delivered by dentists in a dental setting. This trial involves the preventive oral health program within the oral health services provided by the ministry of Health Malaysia.

The 5A’s (Ask, Advice, Assess, Assist and Arrange) are the evidence-based framework for structuring smoking cessation in health care settings originally developed as part of the United States Department of Health’s Clinical Practice Guideline. It advises on ways to increase motivation to quit smoking (5 R’s), relating the reasons why to each individual and to re-assess their motivation and readiness to quit during their next visit for patients whom are at the precontemplation and contemplation stage of change. Patients in the preparation or action stage will be advised on the behavioural strategies to cope with withdrawal symptoms and relapse prevention. Later, patients in this intervention will receive self-help pamphlets and are encouraged to have a quit date within 2 weeks after this first visit.

The brief advice consists of verbal instructions to stop smoking with or without added information about the harmful effects of smoking. Patients will be given a brief message that includes the following:
1. The choice not to smoke has many benefits, including better oral health and more nice-looking teeth
2. I will give you a brochure that contains helpful information about quit smoking
3. Refraining from smoking can be hard, but it is important for your health

During the patients’ dental visit, a receptionist at the registration counter of each dental clinic will invite patients who fit the inclusion criteria of this trial to participate. Once agreed, an explanation of the study will be give

Primary Outcome(s)

1. 30-days prolonged abstinence, self-reported
2. Abstinence at 6 months, measured with a carbon monoxide monitor

Secondary Outcome(s)

Behaviour change of smokers at any level of stage of change based on the Contemplation Ladder questionnaire at 1-month and 3-months follow-up.

The stages of change were defined as follows:
1. Precontemplation: not thinking of quitting within the next 6 months
2. Contemplation: considering quitting in the next 6 months, but has no plans
3. Preparation: considering quitting in the next 30 days and has taken some behavioural steps in this direction
4. Action: quit in the last 6 months

Secondary ID(s)

NMRR-13-406-15721

Source(s) of Monetary Support

Universiti Malaya

Ethics review

Status:
Approval date:
Contact:

1. Faculty of Dentistry University of Malaya Research Ethics Committee, ref: DF CO1301/003(P) 2. Ministry of Health Malaysia, Medical Research Ethics Committee (MREC), ref: KKM/NIHSEC/ P13-551)

Results

• Results available: Yes
• Date Completed: 10/08/2015