Investigate whether the "Smarter Pregnant" intervention in comparison with four screenings with food- and lifestyle advising leads to an improvement in unhealthy food habits (vegetables, fruit, folic acid use) after 24 weeks intervention,…
ID
Source
Brief title
Condition
- Other condition
- Sexual function and fertility disorders
Synonym
Health condition
Preconceptieperiode en zwangerschap
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of reduction of unhealthy food habits after 24 weeks as measured
with the Food Risk Score of future parents (short term).
Secondary outcome
- Percentage of reduction in smoking habits after 24 weeks of future parents.
- Percentage higher chance to become pregnant.
- Percentage of reduction of Big3 complications.
- Percentage of reduction of medical costs as a result of fertility treatments
and perinatal and neonatal care of newborns.
Background summary
In The Netherlands, especially in big cities such as Rotterdam, not only the
mortality rates of newborns are higher than in the rest of Europe, but also
Big3 complications (foetal growth retardation, premature birth, and congenital
disorders) occur more frequent. Besides this, reduced fertility is an
increasing problem. In more than 80% unhealthy food- and lifestyle habits of
future parents and subfertile couples play a part.
Study objective
Investigate whether the "Smarter Pregnant" intervention in comparison with four
screenings with food- and lifestyle advising leads to an improvement in
unhealthy food habits (vegetables, fruit, folic acid use) after 24 weeks
intervention, measured as a decrease in the Food Risk Score of women and men
with a wish to become pregnant.
Study design
This randomized clinical trial will be carried out in 2 independent and
different study populations.
Intervention
Study Group: 6 screenings of food-and lifestyle habits with *Smarter Pregnant*
and personal coaching during a period of 6 months.
Control group: 4 screenings of food- and lifestyle habits and information
provision with *Smarter Pregnant*.
Study burden and risks
Advantage of participation is that both groups will be well informed about the
importance of food- and lifestyle habits during the preconception period en
during pregnancy. A pregnancy without complications and a healthy child can
however never be guaranteed. There are no risks associated with participation.
The study is carried out in these study populations as *Smarter Pregnant* is
developed specifically for these target groups.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
1) 18 years or older.
2) Desire for a child or <12 weeks pregnant.
3) Having a smartphone with access to internet.
4) Knowledge of the Dutch language.
5) Heterosexual relationship.
6) Written informed consent.
Exclusion criteria
1) No written informed consent of the female partner. If the male partner does not want to participate, the female partner can still participate.
2) Age female partner > 45 years.
3) Women and partner who undergo IVF/ICSI treatment and are linving in the Rotterdam area will be excluded for Studypopulation I and will be invited for Studypopulation II.
4) Women advised by their treating gynaecologist or fertility physician to follow a diet because of their IVF/ICSI treatment.
5) Persons following a specific diet, such as vegetariens and vegans.
6) Persons with an alcohol or drug addiction.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40414.078.12 |