CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 352 enrolled
Drug / intervention
Community level interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02083081
NCT02083081N/ACompleted

Community Intervention to Reduce Tobacco Use Among Alaska Native Pregnant Women

Mayo Clinic·interventional·Posted Mar 11, 2014·Updated Jun 28, 2022

In Brief

A clinical study evaluating Community level intervention for Nicotine Dependence. Completed, enrolled 352 participants across 1 site.

Detailed Summary

In the southwest region of Alaska where the project takes place, 79% of Alaska Native women smoke cigarettes or use smokeless tobacco (ST) during pregnancy. In addition, pregnancy appears to be a high risk period for initiation of tobacco use, primarily ST, among women reporting no use of tobacco 3 months before pregnancy. Intervention efforts targeting the entire community, not only pregnant women, to address social norms about tobacco use may be effective. Thus, the investigators will evaluate the efficacy of a novel, multi-component, theory-based intervention for reducing tobacco use during pregnancy, incorporating both individually targeted and community level components delivered by female elders "Native Sisters." The intervention builds on effective community and individual-based approaches for tobacco cessation and lay health advisor approaches for cancer prevention among Native American women. As part of the intervention, a social marketing campaign including digital stories and other small media will be developed with community feedback. Individually targeted components will be six 30-40 minute telephone or home-based peer counseling sessions with pregnant women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 11, 2014
Enrollment StartMay 1, 2014
Primary CompletionDec 1, 2020
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 12.3 years ago

Interventions

Community level interventionbehavioral

Community intervention plus individual counseling