Community Intervention to Reduce Tobacco Use in Pregnant Women

NCT02083081 | Completed Results

• 2 other identifiers: 13-0088241R01CA164533
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nicotine Dependence

Keywords

tobacco; smoking

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Tobacco Abstinence at 6-months Post-partum

  Total number of participants to have biochemically confirmed tobacco abstinence at 6-months post-partum

  6 months postpartum

• Number of Participants With Tobacco Abstinence at End of Pregnancy

  Total number of participants to have biochemically confirmed tobacco abstinence at end of pregnancy (delivery).

  Approximately 9 months

Secondary Outcomes (1)

• Change in Self-efficacy for Non-tobacco Use Scores

  Baseline, 6 months postpartum

Study Arms (2)

community intervention

EXPERIMENTAL

Community level intervention (Social marketing campaign delivered to entire village) plus individual peer counseling sessions for enrolled pregnant women

Behavioral: Community level intervention

usual care

NO INTERVENTION

Usual care provided by health aides to pregnant women

Interventions

Community level intervention BEHAVIORAL

Community intervention plus individual counseling

community intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• plans to have an abortion

Sponsors & Collaborators

• Mayo Clinic: lead
• Yukon Kuskokwim Health Corporation: collaborator
• University of Minnesota: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Yukon Kuskokwim Health Corporation

Bethel, Alaska, 99559, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Limitations and Caveats

challenges obtaining biochemical verification by mail

Results Point of Contact

• Title: Christi Patten PhD
• Organization: Mayo Clinic

patten.christi@mayo.edu

507-538-7370

Study Officials

• Christi A Patten, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 11, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 28, 2022
• Results First Posted: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)