To study if a blended personalized periconception lifestyle care approach aimed at women with a high risk for pregnancy complications who are contemplating pregnancy or already pregnant (*12 weeks) can significantly reduce Lifestyle Risk Score.
ID
Source
Brief title
Condition
- Other condition
- Sexual function and fertility disorders
Synonym
Health condition
Periconceptionele periode en zwangerschap
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Overweightness (Body Mass Index (BMI)*25), and specifically obesity (BMI*30) is
a pressing public health issue. One of the groups most heavily affected by this
global epidemic are women of reproductive age. Maternal obesity has a
significant impact on fertility, maternal pregnancy complications, such as
hypertensive disorders and gestational diabetes, as well as on neonatal
outcomes, which even can lead to transgenerational health problems. Moreover,
these outcomes can as well be influenced by an impaired mental health. All
these consequences increase health care utilization and expenditures. Improved
adherence to a healthy lifestyle can significantly decrease overweightness and
obesity prevalence for this group. Therefore, optimizing lifestyle, including
mental health, is imperative. An intervention targeting patient couples,
starting periconception care early and using personalized medicine is therefore
warranted.
Study objective
To study if a blended personalized periconception lifestyle care approach aimed
at women with a high risk for pregnancy complications who are contemplating
pregnancy or already pregnant (*12 weeks) can significantly reduce Lifestyle
Risk Score.
Study design
A randomized controlled trial in an academic center.
Intervention
Blended personalized periconception lifestyle approach with a mental health
component.
Study burden and risks
No burden or risks are associated with participation. Both the intervention
group and control group (usual care) will receive the evidence-based lifestyle
program Smarter Pregnancy for free.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
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
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 | NL72582.078.20 |