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N/A N=352 Randomized Treatment

Community Intervention to Reduce Tobacco Use in Pregnant Women

Nicotine Dependence

Enrolled (actual)
352
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Number of Participants With Tobacco Abstinence at 6-months Post-partum — 161; 135 Participants — p=0.38

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Community level intervention (Behavioral)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Mayo Clinic
Primary completion
Dec 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Tobacco Abstinence at 6-months Post-partum
161; 135 0.38
PRIMARY
Number of Participants With Tobacco Abstinence at End of Pregnancy
122; 111 0.45
SECONDARY
Change in Self-efficacy for Non-tobacco Use Scores
7.2; 7.5 0.96

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.

Eligibility Criteria

Inclusion Criteria

  • Alaska Native
  • >18 years of age
  • able to provide written informed consent
  • currently pregnant and at < 26 weeks gestation
  • has access to a working telephone.

Exclusion Criteria

  • plans to have an abortion
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02083081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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