Generation R Next intervention study
Recruiting
- Conditions
- stress in het dagelijks levenPerinatal morbidity and mortality / adverse birth outcomes1001027310024450
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1750
Inclusion Criteria
Women and their partners:
* Planning a pregnancy or early pregnancy up to < 11 weeks;
* With the presence of at least one of the predetermined risk factors;
* Residential address in the municipality of Rotterdam and expected residential
address in the municipality of Rotterdam at the birth of their child;
* Sufficient command of the Dutch language;
* Consent for participation in Generation R Next intervention study.
Exclusion Criteria
* Temporary or complete withdrawal from participation;
* Gestational age >= 11+0 at study entry.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The intervention study will focus on at least one of the following parameters:<br /><br>preterm birth (birth after < 37 weeks of gestational age); low birth weight (<<br /><br>10th percentile); low Apgar score 5 minutes after birth (Apgar score < 7); high<br /><br>birth weight (>90th percentile). These outcomes are strongly related to<br /><br>perinatal morbidity and mortality and unfavorable long-term outcomes in the<br /><br>child. The occurrence of congenital abnormalities is also strongly related to<br /><br>perinatal mortality. However, given the low prevalence of perinatal death and<br /><br>congenital or serious birth defects, these outcomes are not included in this<br /><br>study. The above data will be obtained from information in medical records.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Outcomes in mother: adherence to lifestyle advice / completed lifestyle<br /><br>changes; facilitators / barriers to lifestyle change; sleep/wake rhythm and its<br /><br>improvement; social support (for example from partner); time to pregnancy;<br /><br>miscarriage; weight gain and glucose metabolism during pregnancy; the<br /><br>experienced stress during pregnancy and after childbirth; hypertension during<br /><br>pregnancy; diabetes during pregnancy; breast-feeding; weight maintenance at 6<br /><br>months and 1 year after delivery.<br /><br>Outcomes for partner: compliance with lifestyle advice / completed lifestyle<br /><br>adjustments; facilitators / barriers to lifestyle change; sleep/wake rhythm and<br /><br>its improvement; social support (for example from partner); the experienced<br /><br>stress.<br /><br>Outcomes in child: growth of the child; obesity; behavior; health up to and<br /><br>including 54 months.</p><br>