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Preventing relapse to smoking to extend duration of breastfeeding

Extending Breastfeeding Duration by Preventing Relapse to Smoking among Post-Natal Maori Women: Introducing Vaping Feasibility Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000249156
Enrollment
25
Registered
2019-02-19
Start date
2019-03-18
Completion date
2019-04-12
Last updated
2019-07-15

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

Conditions

None listed

Brief summary

Maori women have the highest smoking rates in New Zealand and the lowest rates for initiating breastfeeding. They also terminate breastfeeding earlier than other ethnic groups. Intent to return to smoking postnatally has been identified as a key reason for not initiating breastfeeding and relapse to smoking has been cited as a reason for stopping breastfeeding prematurely. In this study community health workers will provide advice aimed at extending the average duration of breastfeeding. They will encourage participants to abstain from smoking, but will provide a vape kit for the women to have if they cannot resist the urge to start smoking again. Participants will be advised to stay smokefree and to not vape for as long as possible. They will be advised to breastfeed for as long as they can according to WHO recommendations, even if they vape or relapse to smoking. The women will be surveyed at baseline and weekly for 8 weeks to assess their breastfeeding, smoking or vaping status and to provide support to continue breastfeeding. At the final interview they will be asked about the acceptability of the intervention.

Interventions

A research assistant will advise women that it is best to abstain from smoking altogether while breastfeeding. Postnatal Maori women at high risk of relapsing to smoking will be provided with a lockable storage container including a vaping starter kit containing 2 vaporisers, zero nicotine e-liquid and a 6 or 12mg nicotine e-liquid of a flavour they can choose from a limited range selected. The women will be advised that if they experience strong urges to smoke that they cannot withstand, they s

A research assistant will advise women that it is best to abstain from smoking altogether while breastfeeding. Postnatal Maori women at high risk of relapsing to smoking will be provided with a lockable storage container including a vaping starter kit containing 2 vaporisers, zero nicotine e-liquid and a 6 or 12mg nicotine e-liquid of a flavour they can choose from a limited range selected. The women will be advised that if they experience strong urges to smoke that they cannot withstand, they should use a vaporiser ad libitum as required instead of smoking. The duration of the trial is 8 weeks. Trained research assistants will be deliver the intervention. The research assistant will contact each participant weekly by phone, text, email, or in-person (through weeks 2-7; and in-person at week 8) to ask follow-up questions about current smoking or vaping status, current breastfeeding practice and challenges to continuing to breastfeed. Exhaled carbon monoxide readings will be taken at baseline, and in-person follow-up interviews.

Sponsors

Centre of Research Excellence: Indigenous Sovereignty & Smoking
Lead SponsorOther

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

Participants will be eligible if they self-identify as Maori women, are aged 16 or over and have smoked prior to or during pregnancy but have quit prior to the birth of their infant/s. They must be intending to breastfeed and have no identified impediments to breastfeeding. All participants must be able to speak English and able to give consent on their own behalf.

Exclusion criteria

Women under age 16, who do not self-identify as Maori, and who have not recently been pregnant and women who do not initiate breastfeeding will be excluded. Women who record an exhaled carbon monoxide reading of greater than 6ppm (indicating current smoking) will be excluded. Women who smoke cannabis or who intend to smoke cannabis during the period of the trial will be excluded. Smoking cannabis similarly increases CO in exhaled breath contaminating the detection of current tobacco smoking. Women who are using NRT will be excluded as they are less at risk of relapsing to smoking. Current use of NRT would confound the need for vaping.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026