Generation R Next intervention study

Generation R Next intervention study - Generation R Next

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53844

Enrollment

1750

Registered

2022-12-12

Start date

2023-01-19

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stress in het dagelijks leven Perinatal morbidity and mortality / adverse birth outcomes

Interventions

After randomization, there will be two groups: the intervention group and the control group. The intervention group will attend three group sessions (online or physical, depending on the current cov

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Women and their partners: * Planning a pregnancy or early pregnancy up to

Exclusion criteria

Exclusion criteria: * Temporary or complete withdrawal from participation; * Gestational age >= 11+0 at study entry.

Design outcomes

Primary

Measure	Time frame
The intervention study will focus on at least one of the following parameters: preterm birth (birth after 90th percentile). These outcomes are strongly related to perinatal morbidity and mortality and unfavorable long-term outcomes in the child. The occurrence of congenital abnormalities is also strongly related to perinatal mortality. However, given the low prevalence of perinatal death and congenital or serious birth defects, these outcomes are not included in this study. The above data will be obtained from information in medical records.	—

Measure

Time frame

The intervention study will focus on at least one of the following parameters: preterm birth (birth after 90th percentile). These outcomes are strongly related to perinatal morbidity and mortality and unfavorable long-term outcomes in the child. The occurrence of congenital abnormalities is also strongly related to perinatal mortality. However, given the low prevalence of perinatal death and congenital or serious birth defects, these outcomes are not included in this study. The above data will be obtained from information in medical records.

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Secondary

Measure	Time frame
Outcomes in mother: adherence to lifestyle advice / completed lifestyle changes; facilitators / barriers to lifestyle change; sleep/wake rhythm and its improvement; social support (for example from partner); time to pregnancy; miscarriage; weight gain and glucose metabolism during pregnancy; the experienced stress during pregnancy and after childbirth; hypertension during pregnancy; diabetes during pregnancy; breast-feeding; weight maintenance at 6 months and 1 year after delivery. Outcomes for partner: compliance with lifestyle advice / completed lifestyle adjustments; facilitators / barriers to lifestyle change; sleep/wake rhythm and its improvement; social support (for example from partner); the experienced stress. Outcomes in child: growth of the child; obesity; behavior; health up to and including 54 months.	—

Measure

Time frame

Outcomes in mother: adherence to lifestyle advice / completed lifestyle changes; facilitators / barriers to lifestyle change; sleep/wake rhythm and its improvement; social support (for example from partner); time to pregnancy; miscarriage; weight gain and glucose metabolism during pregnancy; the experienced stress during pregnancy and after childbirth; hypertension during pregnancy; diabetes during pregnancy; breast-feeding; weight maintenance at 6 months and 1 year after delivery. Outcomes for partner: compliance with lifestyle advice / completed lifestyle adjustments; facilitators / barriers to lifestyle change; sleep/wake rhythm and its improvement; social support (for example from partner); the experienced stress. Outcomes in child: growth of the child; obesity; behavior; health up to and including 54 months.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)