PregnancySmokefreeMOMNCT02412956
SmokefreeMOM: Reaching Pregnant Smokers With Health Information Via Text Messaging
A study testing SmokefreeMOM Text in people with Pregnancy and Smoking Cessation, run by George Washington University at 1 site in United States.
Trial summary
Despite the great health benefits associated with smoking cessation in pregnancy to both mother and baby, few studies to date have examined the applications of text messaging or other communication technologies for smoking cessation in this population. Read more about this study
- Who is it for?
- Ages 13 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Smoking Cessation
- What is being tested?
- SmokefreeMOM Text
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 44 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- pregnant,
- smoke or quit in the past 2 weeks,
- has a data plan or an unlimited text messaging plan on her cell in order to avoid charges for texts,
- an English speaker.
Who cannot join
- not pregnant
- not currently smoking (or within past 2 weeks)
- not able to receive text messages
- not an English speaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Medstar Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: Quit4Baby: Reaching Pregnant Smokers With Health Information Via Text
Despite the great health benefits associated with smoking cessation in pregnancy to both mother and baby, few studies to date have examined the applications of text messaging or other communication technologies for smoking cessation in this population. This project is the first step in developing a new dissemination strategy for reaching pregnant smokers. This research will explore how a state-of -the-art, interactive and intensive, text messaging program, SmokefreeMoms Text, can promote smoking cessation in pregnant smokers. This program may have the potential to reach pregnant smokers who are not currently being reached with traditional smoking cessation services. The study Aims are: 1) to elicit qualitative feedback from pregnant smokers and recent quitters (in the past month) about the concept of SmokefreeMoms, the proposed message protocols in SmokefreeMoms, and the proposed messages in SmokefreeMoms (Phase 1); 2) To develop and pilot test a prototype of SmokefreeMoms which is consistent with Clinical Practice Guidelines (Phase 2), and 3) To conduct a formative evaluation of SmokefreeMoms 1.0 with pregnant smokers and recent quitters (Phase 3). 4) To measure the likelihood that pregnant women who smoke cigarettes will join an SMS program by responding to different types of recruitment messages.
- Conditions
- Pregnancy, Smoking Cessation
- Being tested
- SmokefreeMOM Text
- Keywords
- mHealth
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmokefreeMOM TextBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | pamphlet |
| Intervention (text) | Experimental | SmokefreeMOM text messaging program Receives: Behavioral: SmokefreeMOM Text |
| Intervention Plus (text+quitline) | Experimental | SmokefreeMOM text messaging program + state quitline Receives: Behavioral: SmokefreeMOM Text |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence
7-day point prevalence abstinence measured by Self-Report and Confirmed with Saliva Cotinine
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startJan 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorien Abroms, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412956
- Sponsor's protocol ID
- R15CA167586
- Acronym
- SmokefreeMOM
- Status last verified
- Oct 2021
- First submitted
- 31 Mar 2015
- Last updated
- 26 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
PubMed 32813276Abroms LC, Chiang S, Macherelli L, Leavitt L, Montgomery M. Assessing the National Cancer Institute's SmokefreeMOM Text-Messaging Program for Pregnant Smokers: Pilot Randomized Trial. J Med Internet Res. 2017 Oct 3;19(10):e333. doi: 10.2196/jmir.8411.
PubMed 28974483
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quit4Baby: Reaching Pregnant Smokers With Health Information Via Text
- ClinicalTrials.gov ID
- NCT02412956
- Acronym / sponsor ID
- SmokefreeMOM / R15CA167586
- Conditions
- Pregnancy, Smoking Cessation
- Keywords
- mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Posted 26 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the great health benefits associated with smoking cessation in pregnancy to both mother and baby, few studies to date have examined the applications of text messaging or other communication technologies for smoking cessation in this population. This project is the first step in developing a new dissemination strategy for reaching pregnant smokers. This research will explore how a state-of -the-art, interactive and intensive, text messaging program, SmokefreeMoms Text, can promote smoking cessation in pregnant smokers. This program may have the potential to reach pregnant smokers who are not currently being reached with traditional smoking cessation services. The study Aims are: 1) to elicit qualitative feedback from pregnant smokers and recent quitters (in the past month) about the concept of SmokefreeMoms, the proposed message protocols in SmokefreeMoms, and the proposed messages in SmokefreeMoms (Phase 1); 2) To develop and pilot test a prototype of SmokefreeMoms which is consistent with Clinical Practice Guidelines (Phase 2), and 3) To conduct a formative evaluation of SmokefreeMoms 1.0 with pregnant smokers and recent quitters (Phase 3). 4) To measure the likelihood that pregnant women who smoke cigarettes will join an SMS program by responding to different types of recruitment messages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –pamphlet |
| Intervention (text) | Experimental | Behavioral: SmokefreeMOM TextSmokefreeMOM text messaging program |
| Intervention Plus (text+quitline) | Experimental | Behavioral: SmokefreeMOM TextSmokefreeMOM text messaging program + state quitline |
Who may qualify
- Ages
- 13 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- pregnant,
- smoke or quit in the past 2 weeks,
- has a data plan or an unlimited text messaging plan on her cell in order to avoid charges for texts,
- an English speaker.
Key exclusion criteria (4 listed)
- not pregnant
- not currently smoking (or within past 2 weeks)
- not able to receive text messages
- not an English speaker
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 |
|---|---|---|
| SmokefreeMOM Text | Behavioural | Intervention (text), Intervention Plus (text+quitline) |
Primary outcome
Smoking Abstinence
Time frame: 3 months
7-day point prevalence abstinence measured by Self-Report and Confirmed with Saliva Cotinine
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32813276Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
- Derived from this study: PubMed 28974483Abroms LC, Chiang S, Macherelli L, Leavitt L, Montgomery M. Assessing the National Cancer Institute's SmokefreeMOM Text-Messaging Program for Pregnant Smokers: Pilot Randomized Trial. J Med Internet Res. 2017 Oct 3;19(10):e333. doi: 10.2196/jmir.8411.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmokefreeMOM Text in people with Pregnancy and Smoking Cessation, run by George Washington University 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 4 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 26 Nov 2021. 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?
Yes. Results are posted in the registry (first posted 26 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Smoking Abstinence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02412956, which also lists 2 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 26 Nov 2021.