Smoking CessationNCT05041413
Helping Moms Quit Pilot Trial
A study testing Moms Quit and Text4Baby in people with Smoking Cessation, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The objective of this study is to test the feasibility and preliminary effectiveness of a tailored text message program to support smoking abstinence among postpartum women who smoke or recently quit. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Moms Quit and Text4Baby
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2021to 5 Oct 2022
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Less than one month postpartum
- Live delivery
- Smoked at least 100 cigarettes/lifetime
- Smoked anytime during their most recent pregnancy
- English-speaking
- Own a mobile phone
Show all 10Show fewer
- Provide an email address
- Willing to receive intervention-related texts
- Willing to complete surveys
- Willing to provide a saliva sample at the end of the study
Who cannot join
- Women whose pregnancy did not result in live birth
- On a 7-point scale, participant indicates that they are not interested in quitting or staying quit in the next 6 months (Not at all = 1).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Enhancing the Delivery of Tobacco Treatment During Pregnancy and Postpartum Though Systems-Change
The objective of this study is to test the feasibility and preliminary effectiveness of a tailored text message program to support smoking abstinence among postpartum women who smoke or recently quit.
Read the detailed description
This pilot trial will evaluate a text message intervention (Moms Quit) to be initiated with postpartum women within one month of delivery. Moms Quit is a tailored program to support smoking abstinence among new mothers who are either current smokers or quit during their most recent pregnancy. Investigators will randomize 30 postpartum women, stratified by recent/current smoking status, into Moms Quit versus vs. CONTROL. Investigators hypothesize that participants receiving Moms Quit will have, on average, a significantly longer period of self-reported prolonged abstinence compared to CONTROL.
- Conditions
- Smoking Cessation
- Being tested
- Moms Quit, Text4Baby
- Keywords
- Postpartum women
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moms QuitBehavioural
Participants will receive text messages tailored on (1) current smoking status and (2) intention to quit/remain quit. Message content includes supportive messaging for child and self-care, relapse prevention, and smoking cessation. Women who are ready to quit will receive messages from the SmokeFreeText library.
Text4BabyBehavioural
Text4Baby is a free, publicly available text messaging program that provides information about nutrition, safe sleep tips, baby's milestones, signs and symptoms of labor, doctor visit and appointment reminders, breastfeeding advice, car seat safety, information on health insurance, urgent health alerts, and resource hotlines and websites.
| Study group | Role | What they receive |
|---|---|---|
| Moms Quit Intervention | Experimental | 12 weeks of the Moms Quit text message intervention Receives: Behavioral: Moms Quit |
| Text4Baby | Active comparator | 12 weeks of Text4Baby messages Receives: Behavioral: Text4Baby |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days abstinent in the past 30 days
Self-reported abstinence in the past 30 days
Measured: 12 weeks post-randomization
Secondary outcomes (1)
7 day point prevalence abstinence
Biochemically verified 7 day point prevalence abstinence using salivary cotinine with a 13ng/ml cut off
Measured: 12 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start11 Aug 2021
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041413
- Sponsor's protocol ID
- K01DA040745_1
- Other IDs
- K01DA040745
- Status last verified
- Nov 2022
- First submitted
- 2 Sep 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Delivery of Tobacco Treatment During Pregnancy and Postpartum Though Systems-Change
- ClinicalTrials.gov ID
- NCT05041413
- Acronym / sponsor ID
- K01DA040745_1
- Conditions
- Smoking Cessation
- Keywords
- Postpartum women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 13 Sep 2021 (actual)
- 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 objective of this study is to test the feasibility and preliminary effectiveness of a tailored text message program to support smoking abstinence among postpartum women who smoke or recently quit.
Detailed description
This pilot trial will evaluate a text message intervention (Moms Quit) to be initiated with postpartum women within one month of delivery. Moms Quit is a tailored program to support smoking abstinence among new mothers who are either current smokers or quit during their most recent pregnancy. Investigators will randomize 30 postpartum women, stratified by recent/current smoking status, into Moms Quit versus vs. CONTROL. Investigators hypothesize that participants receiving Moms Quit will have, on average, a significantly longer period of self-reported prolonged abstinence compared to CONTROL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moms Quit Intervention | Experimental | Behavioral: Moms Quit12 weeks of the Moms Quit text message intervention |
| Text4Baby | Active comparator | Behavioral: Text4Baby12 weeks of Text4Baby messages |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Less than one month postpartum
- Live delivery
- Smoked at least 100 cigarettes/lifetime
- Smoked anytime during their most recent pregnancy
- English-speaking
Key exclusion criteria (2 listed)
- Women whose pregnancy did not result in live birth
- On a 7-point scale, participant indicates that they are not interested in quitting or staying quit in the next 6 months (Not at all = 1).
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 |
|---|---|---|
| Moms QuitParticipants will receive text messages tailored on (1) current smoking status and (2) intention to quit/remain quit. Message content includes supportive messaging for child and self-care, relapse prevention, and smoking cessation. Women who are ready to quit will receive messages from the SmokeFreeText library. | Behavioural | Moms Quit Intervention |
| Text4BabyText4Baby is a free, publicly available text messaging program that provides information about nutrition, safe sleep tips, baby's milestones, signs and symptoms of labor, doctor visit and appointment reminders, breastfeeding advice, car seat safety, information on health insurance, urgent health alerts, and resource hotlines and websites. | Behavioural | Text4Baby |
Primary outcome
Days abstinent in the past 30 days
Time frame: 12 weeks post-randomization
Self-reported abstinence in the past 30 days
1 secondary outcome
7 day point prevalence abstinence
Time frame: 12 weeks post-randomization
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 4 Nov 2022.
- Individual participant dataSharing planned: No
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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 Moms Quit and Text4Baby in people with Smoking Cessation, run by University of Kansas Medical Center 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 10 inclusion and 2 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 4 Nov 2022. 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.
What does the primary outcome measure?
Days abstinent in the past 30 days (time frame: 12 weeks post-randomization). It is what the study was designed to measure, not a finding.
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 4 Nov 2022.