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Sustaining Women's Smoking Cessation Postpartum
This study has been completed.
First Received: May 25, 2000   Last Updated: June 23, 2005   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00005719
  Purpose

To conduct a five-year demonstration and education project to sustain smoking cessation postpartum by women who had stopped smoking in pregnancy.


Condition
Lung Diseases
Cardiovascular Diseases
Heart Diseases

MedlinePlus related topics: Heart Diseases Postpartum Care Quitting Smoking Smoking Smoking and Youth
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 1990
Estimated Study Completion Date: June 1996
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Study ID Numbers: 4928
Study First Received: May 25, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00005719     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Smoking
Heart Diseases
Respiratory Tract Diseases
Lung Diseases

Additional relevant MeSH terms:
Heart Diseases
Respiratory Tract Diseases
Lung Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009