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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.

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.

SUBMITTER: Patten CA

PROVIDER: S-EPMC6407629 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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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.

Patten Christi A CA Lando Harry A HA Desnoyers Chris A CA Barrows Yvette Y Klejka Joseph J Decker Paul A PA Hughes Christine A CA Bock Martha J MJ Boyer Rahnia R Resnicow Kenneth K Burhansstipanov Linda L

Contemporary clinical trials 20190128

<h4>Background</h4>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.<h4>Design</h4>Cluster-randomized controlled trial with village as the unit of assignment. Sixteen villages ...[more]

PMID: 30703523

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Project description:INTRODUCTION:In general population samples, higher levels of stress and depression have been associated with increased prevalence of smoking in pregnancy. Little is known about the association of prenatal tobacco use, stress, and depression among American Indian or Alaska Native (AI/AN) women. METHODS:The Healthy Pregnancies Project is a cluster-randomized controlled trial, evaluating a community-level intervention compared with usual care, for reducing tobacco use during pregnancy and postpartum among AN women in 16 villages in western Alaska. This cross-sectional study analyzed baseline data from enrolled pregnant women. Baseline measures included the self-reported, 7-day, point-prevalence current use of any tobacco, Perceived Stress Scale (PSS), and the Center for Epidemiological Studies-Depression (CES-D). Generalized estimating equations (GEE) analyses adjusted for village, participant age, and gestational age. RESULTS:Participants (N = 352) were on average (SD) 25.8 (5.0) years of age and at 26.8 (9.8) weeks gestation. 66.5% were current tobacco users, of which 77% used Iqmik, a homemade form of smokeless tobacco. Compared with nonusers, tobacco users reported lower PSS score (p = .020) and less clinical levels of depression (CES-D ? 16) (18.1% vs. 9.3%, p = .21). Findings were not accounted for by nicotine dependence severity or self-reported tobacco use before pregnancy. CONCLUSIONS:In this sample of pregnant AN women, tobacco users report less stress and clinical levels of depression than nonusers. A potential challenge with tobacco treatment for pregnant AN women is to provide alternative ways of deescalating stress and affect management instead of using tobacco. IMPLICATIONS:This study contributes novel information on the association of tobacco use, perceived stress, and depression among Alaska Native women enrolled in a clinical trial to promote healthy pregnancies. Most prior studies addressing this topic were conducted among general population samples of pregnant women who smoked cigarettes. Little is known about these associations with prenatal smokeless tobacco, or among American Indian or Alaska Native women. The results are contrary to findings reported previously, because current tobacco use was associated with less stress and depression than nonuse. The study findings have implications for cessation treatment for this tobacco-use disparity group.

Project description:IntroductionDiet, shown to impact colorectal cancer (CRC) risk, is a modifiable environmental factor. Fibre foods fermented by gut microbiota produce metabolites that not only provide food for the colonic epithelium but also exert regulatory effects on colonic mucosal inflammation and proliferation. We describe methods used in a double-blinded, randomised, controlled trial with Alaska Native (AN) people to determine if dietary fibre supplementation can substantially reduce CRC risk among people with the highest reported CRC incidence worldwide.Methods and analysesEligible patients undergoing routine screening colonoscopy consent to baseline assessments and specimen/data collection (blood, urine, stool, saliva, breath and colon mucosal biopsies) at the time of colonoscopy. Following an 8-week stabilisation period to re-establish normal gut microbiota post colonoscopy, study personnel randomise participants to either a high fibre supplement (resistant starch, n=30) or placebo (digestible starch, n=30) condition, repeating stool sample collection. During the 28-day supplement trial, each participant consumes their usual diet plus their supplement under direct observation. On day 29, participants undergo a flexible sigmoidoscopy to obtain mucosal biopsy samples to measure the effect of the supplement on inflammatory and proliferative biomarkers of cancer risk, with follow-up assessments and data/specimen collection similar to baseline. Secondary outcome measures include the impact of a high fibre supplement on the oral and colonic microbiome and biofluid metabolome.Ethics and disseminationApprovals were obtained from the Alaska Area and University of Pittsburgh Institutional Review Boards and Alaska Native Tribal Health Consortium and Southcentral Foundation research review bodies. A data safety monitoring board, material transfer agreements and weekly study team meetings provide regular oversight throughout the study. Study findings will first be shared with AN tribal leaders, health administrators, providers and community members. Peer-reviewed journal articles and conference presentations will be forthcoming once approved by tribal review bodies.Trial registration numberNCT03028831.

Dataset Information

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.

Publications

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.

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