Gestation and obesity pregnancy and obesity
Conditions
Interventions
The intervention group receives SP+, while the control group receives Care as
Usual.
Intervention: The 6-month lifestyle care path SP+ involves coaching on healthy
nutrition, folic acid and vitami
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in target group 1, a subject must meet all the following criteria. Women are eligible to participate if: - they are above 18 years of age, - they have a body mass index (BMI) >=30 (BMI is classified according to World Health Organization criteria for adults) - they have a singleton pregnancy of less than 3 months, - they have sufficient understanding of the Dutch or English language, - they have access to a smartphone or tablet, - they have provided informed consent for participation. The partner of the women randomized in the intervention group be invited to participate to involve the close living environment of the woman (intrinsic and extrinsic motivation). The participation of the partner is voluntary. Partners are eligible to participate if: - they are partner of a participating pregnant woman in the intervention group - they are above 18 years of age, - they have sufficient understanding of the Dutch or English language, - they have provided informed consent for participation (PIF partners). Health care providers for target group 2 are eligible if they are involved in the implementation of SP+ and obstetric care. Stakeholders are invited based on their expertise on SP+, technology in general and obesity care. They must provide informed consent for participation after reading the patient information folder.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - not able to give written informed consent - insufficient understanding of the Dutch or English language.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary composite outcome used for the effectiveness is incidence of CVMD (hypertensive pregnancy complications, chronic hypertension, diabetes gravidarum, type I and II diabetes) during the 12 months study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are maternal outcomes, neonatal outcomes, cost-effectiveness. Tertiary outcomes are user satisfaction, reimbursement and implementation roadmaps. | — |
Countries
Netherlands
Contacts
Public ContactR.P.M. Steegers-Theunissen
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed