Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005697
Status:
COMPLETED
Last Update Posted:
2021-10-01
First Post:
2000-05-25
Brief Title:
Intervention for Resistant Pregnant Smokers
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:
This 31-month supplement to Sustaining Womens Smoking Cessation Postpartum Project PANDA designed implemented and evaluated an intensified intervention for pregnant women who were unable to stop smoking with minimal assistance
Detailed Description:
DESIGN NARRATIVE
The substudy was a population-based experiment with White Black and Hispanic pregnant women whose continued smoking made them ineligible for randomization into the parent study It was unique in focusing on heavier more addicted pregnant smokers PANDA research sites and protocols offered a special opportunity for a low cost test of a disseminable intervention which this project team was uniquely qualified to design and implement The new intervention One- to-One used telephone counselors to assess the counselees stage in the change process and give stage-appropriate messages using established techniques of motivational interviewing Between the two counselor calls spaced 10 days apart counselees received personalized written feedback and suggestions The primary aim increasing quitting during pregnancy was assessed by unobtrusive urine samples taken during prenatal visits in the ninth month and identified only by study group
A series of postpartum interviews with subsample cotinine validation was used to examine the second important aim reduction of infant smoke exposure A combination of messages peer modeling and support helped women sustain cessation after delivery and eliminate smoking around the baby Project PANDA videotapes and newsletters already contained these messages and required only minimal supplementation to be used with the One-to-One experimental group regardless of their success in quitting in pregnancy As in Project PANDA the assessments were separated from the experiment by enrolling subjects in a university-sponsored study of new mothers health practices and baby care and by presenting the program as usual care by the health care site
The substudy was a population-based experiment with White Black and Hispanic pregnant women whose continued smoking made them ineligible for randomization into the parent study It was unique in focusing on heavier more addicted pregnant smokers PANDA research sites and protocols offered a special opportunity for a low cost test of a disseminable intervention which this project team was uniquely qualified to design and implement The new intervention One- to-One used telephone counselors to assess the counselees stage in the change process and give stage-appropriate messages using established techniques of motivational interviewing Between the two counselor calls spaced 10 days apart counselees received personalized written feedback and suggestions The primary aim increasing quitting during pregnancy was assessed by unobtrusive urine samples taken during prenatal visits in the ninth month and identified only by study group
A series of postpartum interviews with subsample cotinine validation was used to examine the second important aim reduction of infant smoke exposure A combination of messages peer modeling and support helped women sustain cessation after delivery and eliminate smoking around the baby Project PANDA videotapes and newsletters already contained these messages and required only minimal supplementation to be used with the One-to-One experimental group regardless of their success in quitting in pregnancy As in Project PANDA the assessments were separated from the experiment by enrolling subjects in a university-sponsored study of new mothers health practices and baby care and by presenting the program as usual care by the 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 |
|---|---|---|---|
| R01HL050815 | NIH | None | httpsreporternihgovquickSearchR01HL050815 |