Periconceptionele periode en zwangerschap fertilisation period and pregnancy Periconceptional period and gestation
Conditions
Interventions
Blended personalized periconception lifestyle approach with a mental health
component.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient-couples will be screened for eligibility by their treating physician if: - woman is in reproductive age (18-45 year) - they are contemplating pregnancy or are pregnant (*12 weeks gestation) - they visit the outpatient antenatal clinic in this academic care hospital - the woman is overweight (BMI *25)
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - multiple pregnancy - insufficient knowledge of Dutch language - fetal anomalies - inability to provide informed consent Women can be included as single participant if the partner does not participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of women reaching recommended levels of 5 lifestyle behaviors; translated in to a Lifestyle Risk Score, via online questionnaires in week 0, 6, 12 and 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Several questionnaires, in particular the most relevant ICHOM measurements: - Lifestyle-related behavioral determinants (such as attitude, action control, self-efficacy, intention and motivation) using the Behavioral Determinant Questionnaire, measured at week 0, 6, 18 and 24. - Patient satisfaction measured using Six Simple Questions (SSQ) at week 12 and 24. - Provider feasibility using a 5-point Likert scale 6 and 12 months after the start of this study. - Health status measured using EQ-5D questionnaire at week 12, 18 and 24. - Health-related costs: intramural medical costs (hospital registration), iMCQ52 (extramural medical costs), iPCQ53 (productivity loss). - Maternal pregnancy and neonatal complications. Retrieved from medical files. | — |
Countries
Netherlands
Outcome results
None listed