Tobacco UseNEWSNCT00844818
An Intervention to Address Parental Smoking During the Postpartum Hospitalization.
A study testing Telephone Quitline Enrollment in people with Tobacco Use and Parental Smoking, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of the study is to find better ways to help parents quit smoking, thus improving their own health, the health of their children, and the health of other family members. This study tested the feasibility and acceptability of enrolling parents into a telephone quitline during postpartum hospitalization. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tobacco Use, Parental Smoking
- What is being tested?
- Telephone Quitline Enrollment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Apr 2006
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parents of newborns delivered at MGH ("parent" includes the mother, father or another legal guardian) who are: a) current smokers (have smoked, even a puff, within the last 30 days and/or b) recent quitters (have smoked, even a puff, since 30 days prior to conception);
- Telephone access;
- English competency, adequate to participate in the interview;
- Massachusetts resident for next 3 months (from date of consent).
Who cannot join
- Non-smokers or parents who have not smoked since before one month prior to conception (cessation great than 10 months);
- Non-English speaking;
- Non-Massachusetts residents;
- Any family with critically ill mother or infant that the obstetrical nurse practitioner does not feel is appropriate to be approached;
- Decline participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Using the Postpartum Hospital Stay to Address Mother's and Father's Smoking: the NEWS Study
The purpose of the study is to find better ways to help parents quit smoking, thus improving their own health, the health of their children, and the health of other family members. This study tested the feasibility and acceptability of enrolling parents into a telephone quitline during postpartum hospitalization. Half of the parents in the study received quit smoking assistance (intervention group), and half of the parents did not (control group). The percentage of parental smokers who are enrolled in quit smoking programs by the study follow-up will be greater in the intervention group than in the control group.
Read the detailed description
This is a randomized control trial to test the feasibility and efficacy of modifying hospital staff practices on the postpartum floor and intervening with parents before hospital discharge to help them quit smoking. Over 14 months, we assessed the smoking status of both parents of all newborns delivered at 1 hospital. Moms and dads who were current smokers (1 cigarette, even a puff, in past 30 days) or recent quitters (smoked since one month prior to conception) were eligible for the study. Enrolled parents were randomly assigned to the control or intervention group. The intervention included a brief motivational interview (MI), enrollment in the proactive state quitline, and follow-up faxes to the pediatric, OB, and PCP providers with tailored treatment messages.
- Conditions
- Tobacco Use, Parental Smoking
- Being tested
- Telephone Quitline Enrollment
- Keywords
- smoking cessation, parents
- Medical subject headings
- Tobacco Use, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Quitline EnrollmentBehavioural
The intervention included a brief motivational interview (MI), enrollment in the proactive state quitline, and follow-up faxes to the pediatric, OB, and PCP providers with tailored treatment messages.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Moms and dads who were current smokers (1 cigarette, even a puff, in past 30 days) or recent quitters (smoked since one month prior to conception) |
| Intervention Group | Experimental | Moms and dads who were current smokers (1 cigarette, even a puff, in past 30 days) or recent quitters (smoked since one month prior to conception) Receives: Behavioral: Telephone Quitline Enrollment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startFeb 2005
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Investigators
- Jonathan P Winickoff, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844818
- Sponsor's protocol ID
- 2004P002104
- Acronym
- NEWS
- Status last verified
- Feb 2009
- First submitted
- 12 Feb 2009
- Last updated
- 16 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Postpartum Hospital Stay to Address Mother's and Father's Smoking: the NEWS Study
- ClinicalTrials.gov ID
- NCT00844818
- Acronym / sponsor ID
- NEWS / 2004P002104
- Conditions
- Tobacco Use, Parental Smoking
- Keywords
- smoking cessation, parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Feb 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 16 Feb 2009 (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.
The purpose of the study is to find better ways to help parents quit smoking, thus improving their own health, the health of their children, and the health of other family members. This study tested the feasibility and acceptability of enrolling parents into a telephone quitline during postpartum hospitalization. Half of the parents in the study received quit smoking assistance (intervention group), and half of the parents did not (control group). The percentage of parental smokers who are enrolled in quit smoking programs by the study follow-up will be greater in the intervention group than in the control group.
Detailed description
This is a randomized control trial to test the feasibility and efficacy of modifying hospital staff practices on the postpartum floor and intervening with parents before hospital discharge to help them quit smoking. Over 14 months, we assessed the smoking status of both parents of all newborns delivered at 1 hospital. Moms and dads who were current smokers (1 cigarette, even a puff, in past 30 days) or recent quitters (smoked since one month prior to conception) were eligible for the study. Enrolled parents were randomly assigned to the control or intervention group. The intervention included a brief motivational interview (MI), enrollment in the proactive state quitline, and follow-up faxes to the pediatric, OB, and PCP providers with tailored treatment messages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Moms and dads who were current smokers (1 cigarette, even a puff, in past 30 days) or recent quitters (smoked since one month prior to conception) |
| Intervention Group | Experimental | Behavioral: Telephone Quitline EnrollmentMoms and dads who were current smokers (1 cigarette, even a puff, in past 30 days) or recent quitters (smoked since one month prior to conception) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Parents of newborns delivered at MGH ("parent" includes the mother, father or another legal guardian) who are: a) current smokers (have smoked, even a puff, within the last 30 days and/or b) recent quitters (have smoked, even a puff, since 30 days prior to conception);
- Telephone access;
- English competency, adequate to participate in the interview;
- Massachusetts resident for next 3 months (from date of consent).
Key exclusion criteria (5 listed)
- Non-smokers or parents who have not smoked since before one month prior to conception (cessation great than 10 months);
- Non-English speaking;
- Non-Massachusetts residents;
- Any family with critically ill mother or infant that the obstetrical nurse practitioner does not feel is appropriate to be approached;
- Decline participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone Quitline EnrollmentThe intervention included a brief motivational interview (MI), enrollment in the proactive state quitline, and follow-up faxes to the pediatric, OB, and PCP providers with tailored treatment messages. | Behavioural | Intervention Group |
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 16 Feb 2009.
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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.
Jonathan P Winickoff, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Quitline Enrollment in people with Tobacco Use and Parental Smoking, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. 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 16 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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 16 Feb 2009.