Sustaining Women's Smoking Cessation Postpartum

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Completed
CT.gov ID
NCT00005719
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Study Start Date :
    Jul 1, 1990
    Study Completion Date :
    Jun 1, 1996

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      0 Years to 100 Years
      Sexes Eligible for Study:
      Male
      Accepts Healthy Volunteers:
      No

      No eligibility criteria

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

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

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      The University of Texas Health Science Center, Houston
      ClinicalTrials.gov Identifier:
      NCT00005719
      Other Study ID Numbers:
      • 4928
      • R01HL044898
      First Posted:
      May 26, 2000
      Last Update Posted:
      Oct 1, 2021
      Last Verified:
      Sep 1, 2021
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Oct 1, 2021