Sustaining Women's Smoking Cessation Postpartum

Cardiovascular Diseases Clinical Trial

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Lung Diseases

• NCT number: NCT00005719
• Study type: Observational
• Source: The University of Texas Health Science Center, Houston
• Status: Completed
• Start date: July 1990
• Completion date: June 1996