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


- candidate number15285
- NTR NumberNTR4150
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-aug-2013
- Secondary IDsToetsingOnline: NL40414.078.12 METC 2012-216; TRC A551208
- Public TitleErasmus MC Care Innovation for a healthy pregnancy. Efficacy of "Smarter Pregnant", an interactive food and lifestyle coachingsprogram on the mobile phone.
- Scientific TitleErasmus MC Care Innovation for a healthy pregnancy. Efficacy of "Smarter Pregnant", an interactive food and lifestyle coachingsprogram on the mobile phone.
- ACRONYMSmarter Pregnant II - RCT
- hypothesisIn 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.
- Healt Condition(s) or Problem(s) studiedSmarter Pregnant The Netherlands, Smarter Pregnant Rotterdam
- Inclusion criteria1) 18 years or older.
2) Desire for a child, but not pregnant yet.
3) Having a smartphone with access to internet or having a mobile phone and a computer with access to internet.
4) Knowledge of the Dutch language.
5) Heterosexual relationship.
6) Written informed consent.
- Exclusion criteria1) 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate1-jan-2017
- Target number of participants3000
- InterventionsStudy 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 outcomePercentage of reduction of unhealthy food habits after 24 weeks (=6 months) as measured with the Food Risk Score of future parents (short term).
- Secondary outcome- 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.
- Timepoints- Percentage of reduction of unhealthy food habits after 24 weeks (=6 months)
- Percentage of reduction in smoking habits after 24 weeks (=6 months)
- Trial web sitewww.slimmerzwanger.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. dr. R.P.M. Steegers -Theunissen
- CONTACT for SCIENTIFIC QUERIESProf. dr. R.P.M. Steegers -Theunissen
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryBackground 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.
- Main changes (audit trail)
- RECORD19-aug-2013 - 12-okt-2013


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