Condition category
Respiratory
Date applied
31/03/2011
Date assigned
24/05/2011
Last edited
24/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sophia Chan

ORCID ID

Contact details

4/F William MW Mong Block
21 Sassoon Road
Pokfulam
852
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Family Intervention by nurses and counselors to reduce second hand smoke (SHS) exposure in children in Maternal and Child Health Centers (MCHC) of the Department of Health in Hong Kong a randomized controlled trial

Acronym

Study hypothesis

The study is a randomized controlled trial to evaluate the effectiveness of a multi-step family smoking cessation intervention delivered by nurses to non-smoking mothers’ to execute a household no smoking policy and persuade their smoking husbands to attend a smoking cessation intervention provided by trained smoking cessation counsellors (SCC).

The specific objectives of the study are to:
1. Examine the decline in household SHS exposure in infants
2. Evaluate the effectiveness of a multi-step family smoking cessation intervention to motivate the mothers to execute a household no smoking policy, move husband to a higher stage of readiness to quit, persuade them to participate in a smoking cessation intervention provided by SCC, and quit successfully.

Ethics approval

1. Institutional Review Board of the University of Hong Kong/ Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB) on 31/05/2007 (IRB reference number: UW 07-211)
2. Ethics Committee of the Department of Health, Hong Kong government on 18/02/2008 (Reference number: L/M 281/2007)

Study design

Randomised single-blind standard care-controlled multi-centered study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Passive smoking in children

Intervention

At baseline: The smoking cessation counelors (SCCs) (registered nurses) will:
1. Provide a health education intervention to the mother outlining the hazards of SHS exposure among women and children
2. Encourage the mother to execute a household no-smoking policy at home, and
3. Invite the mother to participate in a smoking cessation group session with the father provided by trained SCCs. An information sheet about the details of the smoking cessation group will be provided to both the father and the mother
4. The SCC will proactively call the father within 2 days to provide motivational telephone counseling
5. Invite the father (and mother) to participate in a smoking cessation group activity (within a month) where free NRT (for 1 week) and discount coupons will be provided for subsequent purchase from outside pharmacists
6. Furthermore, stage-matched smoking cessation materials will be posted to the father
7. If for some reason the family did not attend the group session, NRT will be posted to the father as appropriate

At 1 week and 1 month:
1. SCCs will give telephone reminders to both mothers and fathers to assess the feasibility and any barriers to execute the no-smoking policy at home, to assess the father’s smoking status, further engage him in the behavioral change process, enhance self efficacy, encourage use of self-help materials, and identify subject-specific barriers and facilitators 2. Fathers’ adherence in using NRT and their possible side effects will also be monitored 3. Further health education self-help smoking cessation materials will be posted to the fathers if necessary

Control group:
Mothers will receive standard care routinely provided by the MCHCs, a set of health education materials on the hazards of SHS exposure among women and children and a self-help smoking cessation pamphlet for the smoking fathers

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Child: reduction of infant’s household SHS exposure measured:
1.1. Directly by a decrease in saliva nicotine level
1.2. Indirectly by improving of family smoking hygiene
1.3. Indirectly by reducing health care utilization in particular lower respiratory illnesses in infants at 12 months
2. Mother:
2.1. Reduction of mother’s household SHS exposure
2.2. Mother’s execution of the household no-smoking policy at 12 months.
3. Father:
3.1. The self-reported 12-month quit rates
3.2. The validated 12-month quit rates (7-day point prevalence) of the smoking fathers (defined as not smoking during the 7 days preceding the 12-month follow-up). The 7-day point prevalence is considered to be a reliable measure as most major trials have reported solely the point prevalence

Secondary outcome measures

1. Father:
1.1. 7 day point prevalence self report quit rate at 6-months
1.2. Continuous self-report quit rate at 6-months and 12-months (defined as continuously not smoking during the 12 months preceding the 12-months follow-up)
1.3. Father’s smoking reduction (by at least 50% compared to baseline) at 6-month and 12-month
1.4 Father’s progress in the stage of readiness to quit at 6-month and 12-month
1.5. Quit attempt
2. Cost-effectiveness:
2.1. Costs incurred includes cost of training the nurses
2.2. Cost of delivering the intervention
2.3. Cost of free and discounted nicotine replacement therapy
2.4. Cost of providing self help literature to the fathers
2.5. Cost per quitter and cost per one less hospitalization among infants will be calculated

Overall trial start date

01/06/2008

Overall trial end date

31/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Non-smoking mother aged 18 or above taking her infant to the MCHC
2. Father aged 18 or above smokes one or more cigarettes daily in the past 30 days
3. Father, mother and infant are living together in the same household in the past 7 days
4. Father resides in Hong Kong for at least 5 days a week
5. Both father and mother can communicate in Cantonese

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1152

Participant exclusion criteria

Father is undergoing other smoking cessation programme

Recruitment start date

01/06/2008

Recruitment end date

31/03/2011

Locations

Countries of recruitment

Hong Kong

Trial participating centre

4/F William MW Mong Block
Pokfulam
852
Hong Kong

Sponsor information

Organisation

Flight Attendant Medical Research Institute (USA)

Sponsor details

Miami Center
Suite 1310
201 South Biscayne Boulevard
Miami
Florida
33131
United States of America

Sponsor type

Research organisation

Website

http://www.famri.org

Funders

Funder type

Government

Funder name

Flight Attendant Medical Research Institute, Miami Center, Suite 1310, 201 South Biscayne Boulevard, Miami, Florida 33131 (CIA 062496)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Health and Health Services Research Fund (HHSRF), Food and Health Bureau, Government Secretariat, Hong Kong Government (project number: 05060751)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes