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

Completed
Conditions
Roken en alcoholgebruik tijdens de zwangerschap
Smoking and alcohol use during pregnancy
10010273
Registration Number
NL-OMON48044
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
66
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

- 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary outcome is biochemically validated cessation of smoking and/or<br /><br>alcohol use at:<br /><br>- Week 34 to 38 of gestation (if participants were pregnant at inclusion or<br /><br>became pregnant during the period with sessions);<br /><br>- The end of the project period if <34 weeks pregnant at the time;<br /><br>- On the last measurement after six group sessions in those who were included<br /><br>before pregnancy and did not become pregnant during the period with sessions.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- Barriers and facilitators of implementation (process measures)<br /><br>- Perceived efficiency and appreciation of the eHealth platform, the group<br /><br>sessions, and incentives<br /><br>- Costs<br /><br>- Pregnancy outcomes<br /><br>- Identity changes (identity factors associated with smoking status and/or<br /><br>drinking status)</p><br>
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