Mothers Learning About Second-hand Smoke - MLASS Study

NCT ID: NCT01995409

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30

Brief Summary

Exposure to second-hand smoke during pregnancy and early infancy leads to low birth weight and childhood illnesses. 50% of all newborns in the UK are exposed to tobacco smoke due to maternal smoking or contact with second-hand smoke.

The purpose of this study is to test the feasibility of delivering and evaluating the effectiveness of a Smoke Free Homes (SFH) health education intervention with pregnant women and mothers with newborns to reduce unborn and newborn babies exposure to second-hand smoke. The intervention will be delivered through routine antenatal and postnatal healthcare settings provided by midwifery and health visiting services.

The intervention consists of educational materials to be given to the woman and a conversation held between the woman and midwife/health visitor about protecting the baby from second-hand smoke. The development of the intervention has been informed by the views of health professionals and service users, incorporates behaviour change theory and has drawn on other SFH materials developed for other settings. Different parts of the intervention will be delivered at different points along the antenatal and postnatal care pathway. 200 pregnant women and their newborns will be recruited.

We will measure salivary cotinine levels to assess the level of exposure to SHS in women and urinary cotinine levels in newborns. We plan to conduct a before-and-after study of the delivery of the intervention to test the feasibility of delivering, and methods to evaluate the effectiveness of the intervention.

Feasibility study outputs:

• A standardised, acceptable, feasible and appropriate health education intervention to protect unborn and newborn babies exposure to second-hand smoke at home, capable of being integrated into routine midwifery and health visiting practice
• A trial protocol to evaluate the effectiveness of the intervention on unborn and newborn babies' exposure to secondhand smoke.

Conditions

The Effects of Second-hand Smoke in New Borns

Study Design

• Primary Study Purpose: PREVENTION

Interventions

No smoking material provided in households with newborn infants

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Pregnant
• Smokers; or, non-smokers who live in a household with an adult who smokes or in a household with regular visitors to the home who smoke
• Aged 17-40 years of age
• Born to a woman already recruited into the study

Exclusion Criteria

• Not pregnant or have a miscarriage during pregnancy
• Non-smokers who do not live in a household with an adult who smokes or in a household with regular visitors to the home who smoke
• Having serious health complications during pregnancy or after childbirth
• Having serious health complications after birth or requiring hospitalisation
• Living in neighbourhoods in Leeds that are not among the 40% most deprived in England . being permanently looked after in home separate from mother's

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Leeds Teaching Hospital NHS Trust

Leeds, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Julie Scarfe, RN, RM, BSc, MA.

Role: CONTACT

Julie.Scarfe@leedsth.nhs.uk

0113 2066975

Facility Contacts

Julie Scarfe, RN, RM, BSc, MA.

Role: primary

Other Identifiers

12/YH/0257

Identifier Type: OTHER

Identifier Source: secondary_id

OG13/10649

Identifier Type: -

Identifier Source: org_study_id