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A randomised controlled trial of a high intensity smoking intervention for pregnant Indigenous women

The effect of a multifaceted high intensity culturally specific intervention incorporating advice, support and nicotine replacement on smoking cessation rates in pregnant Indigneous women: a randomised controlled trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000929202
Enrollment
270
Registered
2009-10-28
Start date
2005-11-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of the study was test an intervention designed to improve the extent to which staff in Indigenous primary health care clinics were able to support pregnant women who were smokers to quit smoking during their pregnancy. We hypothesised that among the group of women exposed to the intervention the quit smoking rates would be 20% higher than among the group of women exposed to usual care smoking cessation support and advice.

Interventions

A multifaceted tailored intervention including culturally specific advice and support for Indigenous participants, evidence based communication and nicotine replacement after 2 failed quit attempts. From the time the woman engages in an active quit attempt she is seen again in the clinic at a minimum of 2 visits within 5 and 14 days of the visit at which she agrees to attempt to quit smoking with support and advice. If after two visits with support and advice she is still a smoker trying to qu

A multifaceted tailored intervention including culturally specific advice and support for Indigenous participants, evidence based communication and nicotine replacement after 2 failed quit attempts. From the time the woman engages in an active quit attempt she is seen again in the clinic at a minimum of 2 visits within 5 and 14 days of the visit at which she agrees to attempt to quit smoking with support and advice. If after two visits with support and advice she is still a smoker trying to quit with no contrainications to nicotine replacement therapy and she is prescribed nicotine gum. For smokers of less than 25 cigarettes per day the 2mg gum is prescribed as required up to 24 times per day and for smokers of more than 25 cigarettes per day the 4 mg gum is prescribed. The gum is prescribed as needed for up to 12 weeks.

Sponsors

Professor Sandra Eades
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

Pregnant and attending for antenatal care before 20 weeks gestation

Exclusion criteria

major mental illness or chemical dependency other than tobacco or alcohol

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 26, 2026