Use of the digital intervention BabyBreathe does not appear to significantly help pregnant women to continuously abstain from smoking postpartum when compared with usual care, a study has found.
“Although 5-percent more participants receiving the intervention achieved validated, continuous smoking abstinence at 12 months postpartum compared with usual postpartum care, this difference was not statistically significant,” the investigators said.
“A per protocol analysis did, however, show statistical significance for those who received BabyBreathe,” they added.
A total of 887 participants were randomized to receive BabyBreathe (n=442) or usual care (n=445) between 4 September 2021 and 3 August 2023. One participant was excluded after randomization, leaving 886 individuals in the intention-to-treat analysis. [BMJ 2026;394:e100242]
At 12 months postpartum, smoking abstinence did not significantly differ between BabyBreathe and usual care (54.9 percent vs 49.9 percent; odds ratio [OR], 1.23, 95 percent confidence interval [CI], 0.94‒1.60; p=0.13; risk difference, 4.8 percent, 95 percent CI, ‒1.7 to 11.2; number needed to treat [NNT], 21).
In post hoc per protocol analysis, participants in the BabyBreathe group were more likely to remain free of smoking than those in the usual care group (57.6 percent vs 49.9 percent; adjusted OR, 1.36, 95 percent CI, 1.02‒1.81; p=0.04; risk difference, 7.2 percent, 95 percent CI, 0.3‒14.1; NNT, 13.9). Adverse incidents related to the interventions did not occur.
“[G]iven the intervention fidelity achieved in this trial, BabyBreathe has not been shown to help pregnant women and people remain abstinent postpartum beyond usual care,” the investigators said.
Financial incentives
This study also observed higher rates of sustained abstinence than the highly effective intervention of financial incentives, where 40 percent of participants in the intervention group had sustained abstinence, with 27-percent abstinence rate for the control group, compared with 50 percent in the current trial. [Addiction 2024;119:1352-1363]
“The higher reported rates of sustained abstinence reported across both groups in this trial may reflect the highly motivated, highly educated, and higher socioeconomic status population that we unintentionally recruited, perhaps due to including online recruitment methods and including people who quit in preparation for pregnancy,” the investigators said.
Furthermore, e-cigarette use was high both at baseline and at follow-up across groups, consistent with trends in vaping level in an English population and revealing vape use by pregnant women and people. [https://smokinginengland.info/graphs/e-cigarettes-latest-trends; BJOG Int J Obstet Gynaecol 2021;128:984-993]
“Initially quitting smoking by vaping and then continuing to vape may have aided smoking cessation, although we did not find evidence of this during the study,” the investigators said. “This finding is in line with survey evidence suggesting that sustained regular vaping may promote cessation, although studies directly examining this issue are needed.” [Harm Reduct J 2019;16:76]
BabyBreathe intervention
The current randomized controlled trial was conducted across community health visiting services in the UK and involved pregnant women and people who reported quitting smoking in the 12 months before or during pregnancy, with abstinence verified by exhaled carbon monoxide readings.
BabyBreathe consisted of in-person or remote smoking cessation maintenance interpersonal support at 28‒32 weeks’ gestation and 10‒14 days postpartum. Tailored motivational and educational text messages were provided, with a website and app delivering tailored cessation maintenance advice, social support, motivational tools, and gamification. Control participants received usual postpartum care.