NCT02952703

Brief Summary

This study tests whether a smoking cessation intervention for pregnant women that extends postpartum (Striving to Quit (STQ)) can be implemented and disseminated outside of the research environment that established its effectiveness (40% maintained biochemically verified 6-month abstinence). The research aim is: Is Striving to Quit more effective in achieving postpartum smoking cessation than "First Breath," the current standard of care for pregnant women in Wisconsin who smoke? 250 women will be randomized into one of two study groups. Pregnant women in Group A (n=125) will receive the existing First Breath prenatal intervention. Those in Group B (Striving to Quit (STQ), n=125) will receive all Group A interventions, plus 1 additional prenatal home visit, 3 postpartum in-home smoking cessation counseling visits, 3 postpartum phone calls, and up to an additional $100 in gift cards. The primary outcome will be biochemically confirmed smoking cessation at 6-months postpartum.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

1.5 years

First QC Date

October 31, 2016

Last Update Submit

October 9, 2018

Conditions

SmokingTobacco Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Biochemically verified smoking abstinence

    Biochemically verified smoking abstinence: Breath Carbon Monoxide (CO)\<9ppm

    6 months post intervention

Secondary Outcomes (1)

  • Motivation to quit/remain quit

    6 months post intervention

Study Arms (2)

First Breath

ACTIVE COMPARATOR

brief pre-natal smoking cessation counseling

Behavioral: brief pre-delivery smoking cessation counseling

Striving to Quit

EXPERIMENTAL

Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives

Behavioral: additional pre-delivery smoking cessation counselingBehavioral: post- delivery smoking cessation counselingBehavioral: incentives

Interventions

brief pre-delivery smoking cessation counselingBEHAVIORAL
First Breath
additional pre-delivery smoking cessation counselingBEHAVIORAL
Striving to Quit
post- delivery smoking cessation counselingBEHAVIORAL
Striving to Quit
incentivesBEHAVIORAL
Striving to Quit

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant;
  • enrolled in First Breath;
  • Resides in Wisconsin counties of Calumet, Fond Du Lac, Kewaunee, Menominee, Oconto, Shawno, Sheyboygan, Winnebago, Door, Brown, Outagamie, Manitowac, or Waupaca;
  • English speaking;
  • willingness to quit or reduce smoking in next 30 days or if already quit, desire to remain quit after delivery;
  • daily smoking (at least 1 cigarette/day for at least 1 week in past 6 months;
  • willing to provide updates in contact information

You may not qualify if:

  • not pregnant;
  • not smoking in past 6 months;
  • involved in another smoking research study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Madison, Wisconsin, 53711, United States

Location

MeSH Terms

Conditions

SmokingTobacco Use Disorder

Interventions

Fertility

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 2, 2016

Study Start

November 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

October 12, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)