Erasmus MC Care Innovation for a healthy pregnancy. Efficacy of "Smarter Pregnant", an interactive food and lifestyle coachingsprogram on the mobile phone.

Background of the study:

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.



Objective of the study:

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 (=6 months)
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.



Study population:

Study population I: Women (18-45 years) and their partner living in the Rotterdam area and having the wish to become
pregnant.



Study population II: Women (18-45 years) and their partner living in The Netherlands and having the wish to become pregnant but who will receive IVF or ICSI treatment because of subfertility.



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”.



Primary study parameters/outcome of the study:

Percentage of reduction of unhealthy food habits after 24 weeks (=6 months) as measured with the Food Risk Score of
future parents (short term).



Secundary study parameters/outcome of the study:

- Percentage of reduction in smoking habits after 24 weeks (=6 months) 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.



Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

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.

In comparison with four screenings with food- and lifestyle advising the use of the "Smarter Pregnant" intervention leads to an improvement in unhealthy food habits (vegetables, fruit, folic acid use) after 24 weeks (=6 months) intervention, measured as a decrease in the Food Risk Score of women and men with a wish to become pregnant.

- Percentage of reduction of unhealthy food habits after 24 weeks (=6 months)

- Percentage of reduction in smoking habits after 24 weeks (=6 months)

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”.