Intervention for Resistant Pregnant Smokers
Primary Purpose
Cardiovascular Diseases, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005697
First Posted
May 25, 2000
Last Updated
September 29, 2021
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005697
Brief Title
Intervention for Resistant Pregnant Smokers
Study Type
Observational
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 1996 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
7. Study Design
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
9098952
Citation
Hudmon KS, Mullen PD, Nicol L, Hammond SK, Sockrider MM, Sajak T, Thompson J. Telephone-guided placement and removal of nicotine monitors for the assessment of passive exposure to environmental tobacco smoke. Toxicol Ind Health. 1997 Jan-Feb;13(1):73-80. doi: 10.1177/074823379701300107.
Results Reference
background
PubMed Identifier
9534502
Citation
Mullen PD, Pollak KI, Titus JP, Sockrider MM, Moy JG. Prenatal smoking cessation counseling by Texas obstetricians. Birth. 1998 Mar;25(1):25-31. doi: 10.1046/j.1523-536x.1998.00025.x.
Results Reference
background
PubMed Identifier
9460314
Citation
Groff JY, Mullen PD, Mongoven M, Burau K. Prenatal weight gain patterns and infant birthweight associated with maternal smoking. Birth. 1997 Dec;24(4):234-9. doi: 10.1111/j.1523-536x.1997.tb00596.x.
Results Reference
background
PubMed Identifier
8572037
Citation
Mongoven M, Dolan-Mullen P, Groff JY, Nicol L, Burau K. Weight gain associated with prenatal smoking cessation in white, non-Hispanic women. Am J Obstet Gynecol. 1996 Jan;174(1 Pt 1):72-7. doi: 10.1016/s0002-9378(96)70376-9.
Results Reference
background
Learn more about this trial
Intervention for Resistant Pregnant Smokers
We'll reach out to this number within 24 hrs