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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
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

0 Years - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    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)
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    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

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    Intervention for Resistant Pregnant Smokers

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