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Completed

NCT Number: NCT00005719

Sustaining Women's Smoking Cessation Postpartum

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

Completed

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Key information

Age range

0 year–100 year

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

No eligibility criteria

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
1990
Study completion
1996
First posted
May 26, 2000
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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