The Healthy Pregnancies Project: Study protocol and baseline characteristics for a cluster-randomized controlled trial of a community intervention to reduce tobacco use among Alaska Native pregnant women

Background: Tobacco use prevalence is high among pregnant Alaska Native (AN) women but few interventions have been evaluated for this group. The Healthy Pregnancies Project aims to evaluate a multicomponent intervention for reducing tobacco use during pregnancy and the postpartum period among AN women. This report describes the study protocol and participant baseline characteristics. Design: Cluster-randomized controlled trial with village as the unit of assignment. Sixteen villages in rural southwest Alaska were stratified on village size and randomized to a multicomponent intervention (n = 8 villages) or usual care (n = 8 villages). Methods: Pregnant AN women from the study villages were enrolled. All participants receive the usual care provided to pregnant women in this region. Participants from intervention villages additionally receive individual phone counseling on healthy pregnancies plus a social marketing campaign targeting the entire community delivered by local AN “Native Sisters.” Baseline measurements for all enrolled pregnant women have been completed. Follow-up assessments are ongoing at delivery, and at 2 and 6 months postpartum. The primary outcome is biochemically verified tobacco use status at 6 months postpartum. Results: Recruitment was feasible with 73% of eligible women screened enrolled. The program reached more than half (56%) of AN pregnant women from the study villages during the recruitment period. Participants are N = 352 pregnant AN women, 188 enrolled from intervention villages and 164 from control villages. At baseline, participants’ mean (SD) age was 25.8 (5.0) years, they were at 26.8 (9.8) weeks gestation, and 66.5% were current tobacco users. Discussion: Processes and products from this project may have relevance to other Native American populations aiming to focus on healthy pregnancies in their communities.