The main objective of our research is to study the effectiveness of the SAFER pregnancy intervention in reducing risk behaviour (i.e. smoking and alcohol use) in pregnant women and women with the wish to conceive. The secondary objectives focus on…
ID
Source
Brief title
Condition
- Other condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Health condition
Roken en alcoholgebruik tijdens de zwangerschap
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 <34 weeks pregnant at the time;
- On the last measurement after six group sessions in those who were included
before pregnancy and did not become pregnant during the period with sessions.
Secondary outcome
- 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)
Background summary
Smoking during pregnancy is associated with many adverse perinatal outcomes
such as preterm birth, growth restriction, and perinatal death. Maternal
alcohol use is also associated with adverse health outcomes of the child such
as Fetal Alcohol Spectrum Disorder (FASD). Despite these major risks, 9% of
pregnant women in the Netherlands smoke throughout their pregnancy and 20% uses
alcohol during pregnancy. Particularly smoking is overrepresented among women
with low socioeconomic status (SES).
Shortly before and during pregnancy, women and their partners are more
receptive for lifestyle changes because of the extra responsibility for the
health of their (unborn) child. Recent literature suggests that incentives can
be an effective intervention to realize behavioural change. In addition,
increasing knowledge and health literacy via group sessions and eHealth support
are promising interventions for reducing cigarette and alcohol use among women
who are pregnant or want to become pregnant. In this study we will investigate
a multicomponent intervention, consisting of incentives, group sessions and use
of an eHealth platform to reduce smoking and alcohol use before or during
pregnancy: the SAFER pregnancy intervention.
Study objective
The main objective of our research is to study the effectiveness of the SAFER
pregnancy intervention in reducing risk behaviour (i.e. smoking and alcohol
use) in pregnant women and women with the wish to conceive. The secondary
objectives focus on the assessment of barriers and facilitators of implementing
and complying with this intervention.
Study design
A pre-post design (uncontrolled before-after study) will be used in this
intervention study.
Intervention
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. The SAFER pregnancy intervention
consists of group sessions, active direction towards use of an existing
eHealth platform and provision of incentives upon validated cessation of
smoking and/or alcohol use.
Study burden and risks
At inclusion and at the primary endpoint, smoking behaviour will be
biochemically verified using urinary cotinine and a hand-held exhaled Carbon
Monoxide (CO) monitor (Micro+ Smokerlyzer). During the study period, smoking
behaviour will only be assessed with the CO monitor. Alcohol use will be
assessed with a validated blood test (PhosphatidylEthanol; PEth). At inclusion,
urinary cotinine, exhaled breath CO and serum PEth are quantified depending on
whether participants report smoking and/or drinking. Participants will be asked
to fill in a number of questionnaires during the study period. In addition,
participants are invited to join up to six group sessions each lasting
approximately two hours. The main potential benefit of participation is the
extra support to quit smoking and alcohol use before and during pregnancy,
which can directly benefit their health and the health of their (unborn) child.
In addition, incentives representing monetary value will be issued as part of
the intervention upon biochemically validated risk behaviour cessation.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL67428.078.18 |
| Other | NL7493 |