Sustaining Women's Smoking Cessation Postpartum
Primary Purpose
Lung Diseases, Cardiovascular Diseases, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Lung Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005719
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)
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
background
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Sustaining Women's Smoking Cessation Postpartum
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