Christi A Patten1, Harry A Lando2, Chris A Desnoyers3, Yvette Barrows4, Joseph Klejka5, Paul A Decker6, Christine A Hughes7, Martha J Bock8, Rahnia Boyer9, Kenneth Resnicow10, Linda Burhansstipanov11. 1. Mayo Clinic, Department of Psychiatry and Psychology, BioBusiness Bldg 5-26, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: patten.christi@mayo.edu. 2. University of Minnesota, 1300 2(nd) St, Ste 200, Minneapolis, MN 55454, USA. Electronic address: lando001@umn.edu. 3. Yukon-Kuskokwim Health Corporation, 528 Chief Eddie Hoffman Hwy, Bethel, AK 99559, USA. Electronic address: Christine_Desnoyers@ykhc.org. 4. Yukon-Kuskokwim Health Corporation, 528 Chief Eddie Hoffman Hwy, Bethel, AK 99559, USA. Electronic address: Yvette_Barrows@ykhc.org. 5. Yukon-Kuskokwim Health Corporation, 528 Chief Eddie Hoffman Hwy, Bethel, AK 99559, USA. Electronic address: Joseph_Klejka@ykhc.org. 6. Mayo Clinic, Department of Health Sciences Research, Harwick 7, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: decker.paul@mayo.edu. 7. Mayo Clinic, Department of Psychiatry and Psychology, BioBusiness Bldg 5-26, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: hughes.christine@mayo.edu. 8. Mayo Clinic, Department of Psychiatry and Psychology, BioBusiness Bldg 5-26, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: bock.martha@mayo.edu. 9. Yukon-Kuskokwim Health Corporation, 528 Chief Eddie Hoffman Hwy, Bethel, AK 99559, USA. Electronic address: Rahnia_Boyer@ykhc.org. 10. University of Michigan, 109 S. Observatory, 3867 SPH1, Ann Arbor, MI 48109, USA. Electronic address: kresnic@umich.edu. 11. Native American Cancer Initiatives, Inc., 3022 South Nova Road, Pine, CO 80470, USA. Electronic address: lindab@natamcancer.net.
Abstract
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.
RCT Entities:
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.
Authors: Catherine Chamberlain; Alison O'Mara-Eves; Jessie Porter; Tim Coleman; Susan M Perlen; James Thomas; Joanne E McKenzie Journal: Cochrane Database Syst Rev Date: 2017-02-14
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Authors: Lorraine R Reitzel; Jennifer Irvin Vidrine; Michael S Businelle; Darla E Kendzor; Tracy J Costello; Yisheng Li; Patricia Daza; Patricia Dolan Mullen; Mary M Velasquez; Paul M Cinciripini; Ludmila Cofta-Woerpel; David W Wetter Journal: Nicotine Tob Res Date: 2010-02-12 Impact factor: 4.244
Authors: Christi A Patten; Harry A Lando; Chris A Desnoyers; Joseph Klejka; Paul A Decker; Martha J Bock; Christine A Hughes; Lucinda Alexie; Rahnia Boyer; Kenneth Resnicow; Linda Burhansstipanov Journal: Nicotine Tob Res Date: 2020-10-29 Impact factor: 4.244
Authors: Christi A Patten; Harry A Lando; Chris A Desnoyers; Martha J Bock; Lucinda Alexie; Paul A Decker; Christine A Hughes; Kenneth Resnicow; Linda Burhansstipanov; Rahnia Boyer; Joseph Klejka Journal: Int J Environ Res Public Health Date: 2020-12-12 Impact factor: 3.390