Smoking CessationPRAMSNCT06595199
PRAMS: Peer-support To Reduce Antenatal Maternal Smoking
A study testing Online peer support in people with Smoking Cessation and Pregnancy Related, run by King's College London.
Trial summary
The goal of this feasibility is test the feasibility of conducting a randomised trial of the use of an online peer support group to promote smoking cessation and enhance sustained abstinence for women who smoke in pregnancy. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Pregnancy Related
- What is being tested?
- Online peer support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 2025
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant
- Smoking at beginning of pregnancy
- Access to mobile phone
Who cannot join
- Under 16 years of age
Trial locations and contacts
No sites are listed yet.
Honor Morris contact
About this study
Official title: PRAMS: Peer-support To Reduce Antenatal Maternal Smoking: Development And Feasibility Testing Of A Social Media Group To Provide Peer Support And Enhance Quit Rates For Women Who Smoke In Pregnancy
The goal of this feasibility is test the feasibility of conducting a randomised trial of the use of an online peer support group to promote smoking cessation and enhance sustained abstinence for women who smoke in pregnancy.
Researchers will compare the group who receive the intervention (along side standard care) with a group who receive standard care alone.
Read the detailed description
Participants will be asked to complete 2 questionnaires (and the intervention group will be asked to sign up to an online support group). They will be offered the opportunity to also take part in a follow up interview to explore acceptability and feasibility of the a future trial
- Conditions
- Smoking Cessation, Pregnancy Related
- Being tested
- Online peer support
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online peer supportOther
A closed online peer support group
| Study group | Role | What they receive |
|---|---|---|
| Intervention: online group | Experimental | Online peer support group Receives: Other: Online peer support |
| Control: standard care | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of participants as % of smokers booked at the Trust
Measured: 12 months
Attrition rate
How many participants complete all elements of the study
Measured: 12 months
Secondary outcomes (2)
Smoking status at end of pregnancy
Smoking status at end of pregnancy assessed by self report and cotinine testing
Measured: 12 months
Engagement with stop smoking services
Record of initial and subsequent visits
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Huddersfield, National Institute for Health Research, United Kingdom, The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595199
- Sponsor's protocol ID
- 1670751
- Acronym
- PRAMS
- Status last verified
- Jun 2024
- First submitted
- 13 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a feasibility study , so IPD not relevant
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRAMS: Peer-support To Reduce Antenatal Maternal Smoking: Development And Feasibility Testing Of A Social Media Group To Provide Peer Support And Enhance Quit Rates For Women Who Smoke In Pregnancy
- ClinicalTrials.gov ID
- NCT06595199
- Acronym / sponsor ID
- PRAMS / 1670751
- Conditions
- Smoking Cessation, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University of Huddersfield, National Institute for Health Research, United Kingdom, The Leeds Teaching Hospitals NHS Trust
- Study start
- Oct 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (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 goal of this feasibility is test the feasibility of conducting a randomised trial of the use of an online peer support group to promote smoking cessation and enhance sustained abstinence for women who smoke in pregnancy.
Researchers will compare the group who receive the intervention (along side standard care) with a group who receive standard care alone.
Detailed description
Participants will be asked to complete 2 questionnaires (and the intervention group will be asked to sign up to an online support group). They will be offered the opportunity to also take part in a follow up interview to explore acceptability and feasibility of the a future trial
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: online group | Experimental | Other: Online peer supportOnline peer support group |
| Control: standard care | No intervention | –Standard care |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant
- Smoking at beginning of pregnancy
- Access to mobile phone
Key exclusion criteria (1 listed)
- Under 16 years of age
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 |
|---|---|---|
| Online peer supportA closed online peer support group | Other | Intervention: online group |
Primary outcome
Recruitment rate
Time frame: 12 months
Number of participants as % of smokers booked at the Trust
Attrition rate
Time frame: 12 months
How many participants complete all elements of the study
2 secondary outcomes
Smoking status at end of pregnancy
Time frame: 12 months
Engagement with stop smoking services
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. This is a feasibility study , so IPD not relevant
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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.
Honor Morris contact
Questions about this trial
What is this clinical trial studying?
A study testing Online peer support in people with Smoking Cessation and Pregnancy Related, run by King's College London.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomasina Stacey, PhD (07580345393, tomasina.stacey@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 12 months). The study lists 2 primary outcomes in all. 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 19 Sep 2024; AzTrials last refreshed its copy on 30 Oct 2026.