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Sustaining Women's Smoking Cessation Postpartum

Primary Purpose

Lung Diseases, Cardiovascular Diseases, Heart Diseases

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 Lung 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
    NCT00005719
    Brief Title
    Sustaining Women's Smoking Cessation Postpartum
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1990 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 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
    To conduct a five-year demonstration and education project to sustain smoking cessation postpartum by women who had stopped smoking in pregnancy.
    Detailed Description
    BACKGROUND: The results from this study were expected to demonstrate the effectiveness of a practical program to protect women and their families from direct and indirect smoke exposure and to contribute longitudinal data on change processes involved in smoking cessation, especially those over the maintenance, relapse, and recycling stages, in a relatively complete population through a critical transition. DESIGN NARRATIVE: The TLC Program, unique in its focus on the postpartum period, used a researched model of behavior change that matched messages and skill training with the woman's stage of change. It also addressed the whole family to create a supportive environment for individual change, included other steps for families to protect children from passive smoke and negative modeling, and focused on smoking and smoke exposure directly as well as through self-care and child-care messages. The program used innovative materials, including videotapes and intervention. The study took place in two multi-ethnic health-care sites where the research team had conducted previous studies. The study used a randomized mixed design with 500 women who smoked regularly before pregnancy and who had been abstinent for > 30 days at their 28th week of pregnancy. The primary outcome was abstinence at one year postpartum. Secondary outcomes were partner smoking status and exposure of the index baby. Self report was validated biochemically in samples of mothers and babies. The study design separated data collection from the experiments by enrolling subjects in a university-sponsored study of new mothers' health-care site.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Diseases, Cardiovascular Diseases, Heart Diseases

    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
    7977542
    Citation
    Dolan-Mullen P, Ramirez G, Groff JY. A meta-analysis of randomized trials of prenatal smoking cessation interventions. Am J Obstet Gynecol. 1994 Nov;171(5):1328-34. doi: 10.1016/0002-9378(94)90156-2.
    Results Reference
    background
    PubMed Identifier
    9423498
    Citation
    Mullen PD, Simons-Morton DG, Ramirez G, Frankowski RF, Green LW, Mains DA. A meta-analysis of trials evaluating patient education and counseling for three groups of preventive health behaviors. Patient Educ Couns. 1997 Nov;32(3):157-73. doi: 10.1016/s0738-3991(97)00037-2.
    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
    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
    8830904
    Citation
    Stotts AL, DiClemente CC, Carbonari JP, Mullen PD. Pregnancy smoking cessation: a case of mistaken identity. Addict Behav. 1996 Jul-Aug;21(4):459-71. doi: 10.1016/0306-4603(95)00082-8.
    Results Reference
    background
    PubMed Identifier
    10907650
    Citation
    Stotts AL, DiClemente CC, Carbonari JP, Mullen PD. Postpartum return to smoking: staging a "suspended" behavior. Health Psychol. 2000 Jul;19(4):324-32. doi: 10.1037//0278-6133.19.4.324.
    Results Reference
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