Healthy Pregnancies Project: Cluster Randomized Controlled Trial of a Community Intervention to Reduce Tobacco Use among Alaska Native Women.

Christi A Patten,Lucinda Alexie,Chris A Desnoyers,Paul A Decker,Christine A Hughes,Harry A Lando,Rahnia Boyer,Joseph Klejka,Linda Burhansstipanov,Martha J Bock,Kenneth Resnicow

doi:10.3390/ijerph17249302

Abstract

Substantial gaps remain in the evidence base for prenatal tobacco use interventions among Indigenous women. Using a cluster randomized controlled trial (RCT), the Healthy Pregnancies Project evaluated a community-level intervention for Alaska Native (AN) women in rural western Alaska. Sixteen villages were randomly assigned to usual care (control, n = 8 villages) or usual care plus a community-level intervention delivered by local AN “Native Sisters” (n = 8 villages). Outcomes were tobacco use rate at delivery and at 2 and 6 months postpartum, with biochemical confirmation obtained at 6 months. The program had high reach, enrolling 73% of all eligible women screened. Of the 352 participants, 67% used tobacco at baseline. No significant differences emerged between study groups on follow-up in tobacco use rates. More intervention than control participants made a quit attempt at 2 months postpartum (70% vs. 51%, respectively, p = 0.012). Participants in both study groups reported the program helped to raise awareness of healthy pregnancies in the study villages. This trial supports the reach of a community-level intervention, but not its efficacy for reducing tobacco use during pregnancy or postpartum. Efforts to sustain early quit attempts appear warranted. The community involvement, and reported impact on raising awareness of the importance of healthy pregnancies, supports the value of the research program in this community.

Highlights

Worldwide, Indigenous women are more likely to smoke cigarettes and use smokeless tobacco (ST) during pregnancy compared with non-Indigenous women [1]
In the current Healthy Pregnancies Project, we evaluated a social marketing campaign targeting the entire community, not just pregnant women, to address social norms about tobacco use [7], an approach found to be effective in other contexts for reducing smoking prevalence [8]
The 7-day point-prevalence at each assessment was summarized for each condition and compared between study groups using generalized estimating equations (GEEs) in both: (1) an intent-to-treat (ITT) analysis of all 352 randomized participants, with individuals lost to follow-up or with missing data classified as using tobacco, and (2) a per-protocol analysis including only participants who completed the assessment [25] (313 at delivery and 273 at 2 months and 312 at 6-months postpartum)

Summary

Introduction

Indigenous women are more likely to smoke cigarettes and use smokeless tobacco (ST) during pregnancy compared with non-Indigenous women [1]. Public Health 2020, 17, 9302; doi:10.3390/ijerph17249302 www.mdpi.com/journal/ijerph

Methods

Results

Discussion

Conclusion