Preventing relapse to smoking to extend duration of breastfeeding

Not Applicable

• Conditions: Breast feeding; Smoking Relapse Prevention; Reproductive Health and Childbirth - Breast feeding; Public Health - Health promotion/education; Mental Health - Addiction

• Registration Number: ACTRN12619000249156
• Lead Sponsor: Centre of Research Excellence: Indigenous Sovereignty & Smoking

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-19
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 25

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of intervention as assessed by number enrolled in the study.<br>[At end of 6 month trial.];Acceptability will be assessed in an in-person interview at the end of the 8 week intervention. Qualitative questions will be asked about perceived acceptability of vaping as an alternative to relapsing to smoking amongst post-natal women who initiate breastfeeding and willingness to recommend the intervention to others if it was available.[8 weeks post-partum or post-enrolment if the mother has already given birth at the time of enrolment. ]

Secondary Outcome Measures

Name	Time	Method
Feasibility of choosing vaping as an alternative to relapse to smoking. This will be evaluated by analysing the rates of relapse to smoking versus initiation of vaping or maintenance of abstinence. Interview questions (designed specifically for this study) administered by a research assistant at weeks 2-8 will be used to collect self-reported smoking status and vaping status. At week 8 an exhaled carbon monoxide reading will be taken using a PicoSmokelyser. [At 2-8 weeks.];Feasibility of extending breastfeeding will be assessed using duration of breastfeeding rates and qualitative questions about reasons for ceasing breastfeeding. Interview questions (designed specifically for this study) administered by a research assistant at weeks 2-8 will be used to collect self-reported breastfeeding status.[Weekly and at final 8 week follow-up. ]