PRAMS: Peer-support To Reduce Antenatal Maternal Smoking | NCT06595199

Studies
PRAMS: Peer-support To Reduce Antenatal Maternal Smoking

NCT06595199

Sponsor

King's College London

Status

Unknown status

Last Update Posted

Sep 19, 2024Actual

Enrollment

72Estimated

Phase

Not Applicable

Conditions

Smoking Cessation
Pregnancy Related

Interventions

Online peer support

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2024Estimated

Primary Completion Date

Aug 2025Estimated

Completion Date

Oct 2025Estimated

First Submitted Date

Aug 13, 2024

First Submission Date that Met QC Criteria

Sep 12, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2024

Last Update Posted Date

Sep 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

King's College LondonOTHER

Collaborators

Name	Class
University of Huddersfield	OTHER
National Institute for Health Research, United Kingdom	OTHER_GOV
The Leeds Teaching Hospitals NHS Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention: online group	Experimental	Online peer support group	Other: Online peer support
Control: standard care	No Intervention	Standard care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Online peer support	Other	A closed online peer support group	Intervention: online group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Smoking status at end of pregnancy	Smoking status at end of pregnancy assessed by self report and cotinine testing	12 months
Engagement with stop smoking services	Record of initial and subsequent visits

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant
Smoking at beginning of pregnancy
Access to mobile phone

Exclusion Criteria:

Under 16 years of age

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tomasina Stacey, PhD	Contact	07580345393		tomasina.stacey@kcl.ac.uk
Honor Morris	Contact			PRAMS@kcl.ac.uk

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

This is a feasibility study , so IPD not relevant

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016540	Smoking Cessation

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided