PRAMS: Peer-support To Reduce Antenatal Maternal Smoking
PRAMS
1 other identifier
interventional
72
0 countries
N/A
Brief 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. Researchers will compare the group who receive the intervention (along side standard care) with a group who receive standard care alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedSeptember 19, 2024
June 1, 2024
10 months
August 13, 2024
September 12, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Recruitment rate
Number of participants as % of smokers booked at the Trust
12 months
Attrition rate
How many participants complete all elements of the study
12 months
Secondary Outcomes (2)
Smoking status at end of pregnancy
12 months
Engagement with stop smoking services
12 months
Study Arms (2)
Intervention: online group
EXPERIMENTALOnline peer support group
Control: standard care
NO INTERVENTIONStandard care
Interventions
Eligibility Criteria
You may qualify if:
- Pregnant
- Smoking at beginning of pregnancy
- Access to mobile phone
You may not qualify if:
- Under 16 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King's College Londonlead
- University of Huddersfieldcollaborator
- National Institute for Health Research, United Kingdomcollaborator
- The Leeds Teaching Hospitals NHS Trustcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2024
First Posted
September 19, 2024
Study Start
October 1, 2024
Primary Completion
August 1, 2025
Study Completion
October 1, 2025
Last Updated
September 19, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share
This is a feasibility study , so IPD not relevant