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Intervention for Resistant Pregnant Smokers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00005697
Enrollment
Unknown
Registered
2000-05-26
Start date
1993-01-31
Completion date
1996-12-31
Last updated
2021-10-01

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

Conditions

Cardiovascular Diseases, Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive

Brief summary

This 31-month supplement to Sustaining Women's Smoking Cessation Postpartum (Project PANDA) designed, implemented, and evaluated an intensified intervention for pregnant women who were unable to stop smoking with minimal assistance.

Detailed description

DESIGN NARRATIVE: The substudy was a population-based experiment with White, Black, and Hispanic pregnant women whose continued smoking made them ineligible for randomization into the parent study. It was unique in focusing on heavier, more addicted pregnant smokers. PANDA research sites and protocols offered a special opportunity for a low cost test of a disseminable intervention which this project team was uniquely qualified to design and implement. The new intervention, One- to-One, used telephone counselors to assess the counselee's stage in the change process and give stage-appropriate messages, using established techniques of motivational interviewing. Between the two counselor calls spaced 10 days apart, counselees received personalized written feedback and suggestions. The primary aim, increasing quitting during pregnancy, was assessed by unobtrusive urine samples taken during prenatal visits in the ninth month and identified only by study group. A series of postpartum interviews with subsample cotinine validation was used to examine the second important aim, reduction of infant smoke exposure. A combination of messages, peer modeling, and support helped women sustain cessation after delivery and eliminate smoking around the baby. Project PANDA videotapes and newsletters already contained these messages and required only minimal supplementation to be used with the One-to-One experimental group, regardless of their success in quitting in pregnancy. As in Project PANDA, the assessments were separated from the experiment by enrolling subjects in a university-sponsored study of new mothers' health practices and baby care and by presenting the program as usual care by the health care site.

Interventions

None listed

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Eligibility

Sex/Gender
MALE
Age
0 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

No eligibility criteria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026