Preventing Postpartum Return to Smoking

NCT00917943 | Completed

• 2 other identifiers: Pro000043371R01NR009429-01A2
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

Brief Summary

STUDY PURPOSE: Aim 1. To assess the efficacy of an intervention in preventing or delaying postpartum smoking resumption among women who stop smoking during pregnancy. Aim 2. To determine the association of baseline risk assessment variables (dependence, motivation, self-efficacy, concerns for the fetus, changes in sensory response to tobacco, depression, weight concerns, and partner/household smoking and support) with time to resumption. A two-arm randomized controlled trial will be conducted. Women's risk for resumption will be assessed at 4 time-points.

1. 1.Between 28 and 34 weeks of pregnancy
2. 2.6-weeks postpartum
3. 3.6-months postpartum
4. 4.12-months postpartum
5. 5.One in-person counseling session and at least one telephone session during pregnancy and from 6 to 11 telephone sessions over the first 9-months postpartum.
6. 6.Risk profiles will be used to match the intervention to each woman's needs.
7. 7.Women randomized to the control arm will receive the booklet, Forever Free for Baby and Me and usual prenatal and postpartum care.

Conditions

Smoking

Keywords

smoking; pregnancy; counseling; prevention; tailored intervention; postpartum; women; cessation

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of an intervention in preventing or delaying postpartum smoking resumption among women who stop smoking during pregnancy.

  12 months postpartum

Secondary Outcomes (1)

• To determine the association of baseline risk assessment variables with time to resumption.

  12 months postpartum

Study Arms (2)

Tailored Counseling Intervention Arm

EXPERIMENTAL

Bio-behavioral and pregnancy-specific factors are used to triage women in the treatment arm to one of four levels of stepped-care that includes one in-person counseling session and at least one telephone session during pregnancy and from 6 to 11 telephone sessions over the first 9-months postpartum.

Behavioral: Tailored Counseling Intervention Arm

Control Arm

NO INTERVENTION

Women randomized to the control arm receive the booklet, Forever Free for Baby and Me: A Guide to Remaining Smoke Free and usual prenatal and postpartum care.

Interventions

Tailored Counseling Intervention Arm BEHAVIORAL

Study staff contact women when they are between 28 and 34 weeks pregnant, confirm their non-smoking status, and make an appointment to explain the study further, obtain written informed consent, conduct the risk assessment, and collect baseline data. Bio-behavioral and pregnancy-specific factors are used to triage women in the treatment arm to one of four levels of stepped-care that includes one in-person counseling session and at least one telephone session during pregnancy and from 6 to 11 telephone sessions over the first 9-months postpartum.

Also known as: Nurse Counseling

Tailored Counseling Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Speak English
• Registered for prenatal care
• Have a history of smoking (defined as having smoked at least 100 cigarettes in their lifetimes and at least 5 cigarettes a day prior to becoming pregnant)
• Will need to have been continuously abstinent from tobacco for at least 1 month prior to their risk assessment
• Women will be eligible if they stopped smoking upon learning of their pregnancies and have been continuously abstinent (self-initiated quitters), or if they continued to smoke during the first few months of pregnancy but have been continuously abstinent from 24 to 28 weeks.

You may not qualify if:

• Any women who stopped smoking and resumed by the 34-week risk assessment will be ineligible.

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kathryn I Pollak, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Evan Myers, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 11, 2009
• Study Start: April 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 10, 2013

Record last verified: 2013-04

Locations

US (1)