Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy study
- Conditions
- Roken en alcoholgebruik tijdens de zwangerschapSmoking and alcohol use during pregnancy10010273
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 66
- 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;
- 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
Name Time Method <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
Name Time Method <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>