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Intervention for Resistant Pregnant Smokers
This study has been completed.
Study NCT00005697   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: May 25, 2000   Last Updated: June 23, 2005   History of Changes

May 25, 2000
June 23, 2005
January 1993
 
 
 
Complete list of historical versions of study NCT00005697 on ClinicalTrials.gov Archive Site
 
 
 
Intervention for Resistant Pregnant Smokers
 

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.

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.

 
Observational
Natural History
  • Cardiovascular Diseases
  • Lung Diseases, Obstructive
  • Chronic Obstructive Pulmonary Disease
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
December 1996
 

No eligibility criteria

Male
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00005697
 
4272
National Heart, Lung, and Blood Institute (NHLBI)
 
 
National Heart, Lung, and Blood Institute (NHLBI)
April 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP