Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005719
Status:
COMPLETED
Last Update Posted:
2021-10-01
First Post:
2000-05-25
Brief Title:
Sustaining Womens Smoking Cessation Postpartum
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womans 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
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 womans 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL044898 | NIH | None | httpsreporternihgovquickSearchR01HL044898 |