Lung DiseasesNCT00005719
Sustaining Women's Smoking Cessation Postpartum
An observational study of Lung Diseases and Cardiovascular Diseases, run by The University of Texas Health Science Center, Houston.
Trial summary
To conduct a five-year demonstration and education project to sustain smoking cessation postpartum by women who had stopped smoking in pregnancy. Read more about this study
- Who is it for?
- Ages 0 to 100 years, men only
- Conditions the study is for
- Lung Diseases, Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1990to Jun 1996
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To conduct a five-year demonstration and education project to sustain smoking cessation postpartum by women who had stopped smoking in pregnancy.
Read the 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.
- Conditions
- Lung Diseases, Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Lung Diseases, Cardiovascular Diseases, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1990
- Study completionJun 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005719
- Sponsor's protocol ID
- 4928
- Other IDs
- R01HL044898
- Status last verified
- Sep 2021
- First submitted
- 25 May 2000
- Last updated
- 1 Oct 2021
- Results posted
- No
Publications
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.
PubMed 7977542Mullen 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.
PubMed 9423498Groff 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.
PubMed 9460314Hudmon 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.
PubMed 9098952Stotts 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.
PubMed 8830904Stotts 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.
PubMed 10907650
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustaining Women's Smoking Cessation Postpartum
- ClinicalTrials.gov ID
- NCT00005719
- Acronym / sponsor ID
- 4928
- Conditions
- Lung Diseases, Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 1990
- Study completion
- Jun 1996
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 0 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Background: PubMed 7977542Dolan-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.
- Background: PubMed 9423498Mullen 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.
- Background: PubMed 9460314Groff 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.
- Background: PubMed 9098952Hudmon 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.
- Background: PubMed 8830904Stotts 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.
- Background: PubMed 10907650Stotts 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Cardiovascular Diseases, run by The University of Texas Health Science Center, Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005719, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.