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Community Intervention to Reduce Tobacco Use in Pregnant Women

Community Intervention to Reduce Tobacco Use Among Alaska Native Pregnant Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02083081
Acronym
Sisters
Enrollment
352
Registered
2014-03-11
Start date
2014-05-31
Completion date
2020-12-31
Last updated
2022-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence

Keywords

tobacco, smoking

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.

Detailed description

The project will be conducted in two phases. In Phase I, the investigators will develop the social marketing components by obtaining qualitative feedback from pregnant women, family members and elders on message content and delivery channels. In Phase II, the investigators will evaluate the intervention using a group-randomized design with village as the unit of assignment. Sixteen villages will be randomly assigned to receive the intervention or control condition (usual care), with \> 20 pregnant women enrolled from each village. Assessments will be completed by enrolled women through 6 months postpartum. All aspects of the project will be guided by a Community Advisory Committee. The Specific Aims are: Aim 1. To develop and pre-test the social marketing campaign messages and delivery channels through focus groups and individual interviews of pregnant women, family members, and elders. The focus group work will assess reasons for initiating or continuing tobacco use during pregnancy and the potential role of other community members in addressing tobacco use in pregnancy. Findings will be used to develop campaign messages and media that will be pre-tested through individual interviews and refined. Session content for the individually targeted intervention components will also be developed to align with the campaign messages. Aim 2. To evaluate the efficacy of the intervention compared with the control condition on the biochemically confirmed 7-day point prevalence tobacco use rate at week 36 gestation and at 6 months postpartum. Hypothesis: Compared with the control condition, the intervention will be associated with significantly lower rates of tobacco use in late pregnancy (80% vs. 65%) and at 6 months postpartum (70% vs. 55%). Aim 3. To examine the effect of the intervention on proposed social cognitive-theory based mediators of change including perceived social norms about tobacco use and self-efficacy for non-tobacco use. Hypothesis: Intervention effects on tobacco use at week 36 gestation and at 6 months postpartum will be mediated by perceived self-efficacy and anti-tobacco norms.

Interventions

BEHAVIORALCommunity level intervention

Community intervention plus individual counseling

Sponsors

Yukon Kuskokwim Health Corporation
CollaboratorOTHER
University of Minnesota
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Tobacco Abstinence at 6-months Post-partum6 months postpartumTotal number of participants to have biochemically confirmed tobacco abstinence at 6-months post-partum
Number of Participants With Tobacco Abstinence at End of PregnancyApproximately 9 monthsTotal number of participants to have biochemically confirmed tobacco abstinence at end of pregnancy (delivery).

Secondary

MeasureTime frameDescription
Change in Self-efficacy for Non-tobacco Use ScoresBaseline, 6 months postpartumChange from baseline in self-efficacy for non-tobacco use scores measured by the self-reported Smoking Confidence Questionnaire. Total scores range from 0-30, higher scores indicate better outcome.

Countries

United States

Participant flow

Participants by arm

ArmCount
Community Intervention
Community level intervention (Social marketing campaign delivered to entire village) plus individual peer counseling sessions for enrolled pregnant women Community level intervention: Community intervention plus individual counseling
188
Usual Care
Usual care provided by health aides to pregnant women
164
Total352

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up319

Baseline characteristics

CharacteristicCommunity InterventionUsual CareTotal
Age, Continuous25.9 years
STANDARD_DEVIATION 5
25.8 years
STANDARD_DEVIATION 5
25.8 years
STANDARD_DEVIATION 5
gestational age, weeks27.3 weeks
STANDARD_DEVIATION 9.5
26.2 weeks
STANDARD_DEVIATION 10.1
26.8 weeks
STANDARD_DEVIATION 9.8
Race (NIH/OMB)
American Indian or Alaska Native
188 Participants164 Participants352 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
188 Participants164 Participants352 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1880 / 164
other
Total, other adverse events
0 / 1880 / 164
serious
Total, serious adverse events
0 / 1880 / 164

Outcome results

Primary

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

Time frame: 6 months postpartum

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Community InterventionNumber of Participants With Tobacco Abstinence at 6-months Post-partum161 Participants
Usual CareNumber of Participants With Tobacco Abstinence at 6-months Post-partum135 Participants
p-value: 0.38generalized estimating equations (GEE)
Primary

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).

Time frame: Approximately 9 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Community InterventionNumber of Participants With Tobacco Abstinence at End of Pregnancy122 Participants
Usual CareNumber of Participants With Tobacco Abstinence at End of Pregnancy111 Participants
p-value: 0.45generalized estimating equations (GEE)
Secondary

Change in Self-efficacy for Non-tobacco Use Scores

Change from baseline in self-efficacy for non-tobacco use scores measured by the self-reported Smoking Confidence Questionnaire. Total scores range from 0-30, higher scores indicate better outcome.

Time frame: Baseline, 6 months postpartum

ArmMeasureValue (MEAN)Dispersion
Community InterventionChange in Self-efficacy for Non-tobacco Use Scores7.2 score on a scaleStandard Deviation 2.7
Usual CareChange in Self-efficacy for Non-tobacco Use Scores7.5 score on a scaleStandard Deviation 2.6
p-value: 0.96generalized estimating equations (GEE)

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026