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Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy study

Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy study - SAFER pregnancy study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48044
Enrollment
66
Registered
2019-01-04
Start date
2019-04-03
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Roken en alcoholgebruik tijdens de zwangerschap Smoking and alcohol use during pregnancy

Interventions

In addition to *care as usual* (i.e. referral by their health care professional to cessation services through existing care pathways), all participants will receive the SAFER pregnancy intervention.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Pregnant or having a wish to become pregnant within six months; - Smoking at least 1 cigarette a day and/or drinking three units of alcohol a week;

Exclusion criteria

Exclusion criteria: - less than 18 years of age; - more than 20 weeks pregnant; - inadequate mastery of the Dutch language; - refuses the urinary test and/or breath test (when reporting smoking) or blood test (when reporting drinking alcohol); - the urinary cotinine level is below 50 ug/L, the carbon monoxide (CO) level is less than 7 ppm (when reporting smoking) or the PEth test (when reporting drinking alcohol) is below 7 ug/L at inclusion; - use of hard drugs.

Design outcomes

Primary

MeasureTime frame
The primary outcome is biochemically validated cessation of smoking and/or alcohol use at: - Week 34 to 38 of gestation (if participants were pregnant at inclusion or became pregnant during the period with sessions); - The end of the project period if

Secondary

MeasureTime frame
- Barriers and facilitators of implementation (process measures) - Perceived efficiency and appreciation of the eHealth platform, the group sessions, and incentives - Costs - Pregnancy outcomes - Identity changes (identity factors associated with smoking status and/or drinking status)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)