TOwards Prepared Mums 2 - A lifestyle intervention to reduce gestational weight gain and smoking in pregnant women to prevent perinatal morbidity

A lifestyle intervention to reduce gestational weight gain and smoking in pregnant women to prevent perinatal morbidity

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21149

Enrollment

Registered

2021-05-05

Start date

2018-07-06

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

n.a.

Interventions

personalized lifestyle intervention

Eligibility

Inclusion criteria

Inclusion criteria: • Pregnant women (gestational age = 12 weeks) • Age 18-40 years • Prepregnancy overweight/obesity (BMI = 25.0 kg/m2). Self-reported prepregnancy weight and measured height at baseline will be used to calculate prepregnancy BMI.

Exclusion criteria

Exclusion criteria: • Haemodynamically significant heart disease; • Restrictive lung disease; • Congenital metabolic disease; • Mentally retarded; • Bariatric surgery; • Diabetes type II, dependent on medicine.

Design outcomes

Primary

Measure	Time frame
Gestational weight gain	—

Secondary

Measure	Time frame
• Postpartum weight retention, • Smoking cessation • Dietary habits: 7 day food diary, Three Factor Eating Questionnaire (TFEQ) • Physical activity habits: accelerometry, Baecke questionnaire • Miscarriage: defined as the loss of the fetus before the 20th week of pregnancy. • Pregnancy complications • Vitamin D status: • Childbirth complications • Dysmaturity and macrosomia • Prematurity • Metabolic derangement: blood glucose levels, insulin resistance (HOMA-IR), lipid profile and liver enzymes, OGTT . • Cardiovascular alterations: blood pressure (BP) and pulse wave velocity (PWV), arteriovenous ratio (AV-ratio) derived from retina image. • Microbial flora of the mother(fecal, vaginal, oral) and child (fecal) • Epigenetics (biopsy placenta) • Cord blood glucose, insulin and lipids • Metabolic derangement of the child: bloodglucose, insulin levels and lipid profile of the infants at 1y. • Breast milk composition • Body composition (deuterium method) • Marital status; • Education; • Medical history; • Number of previous pregnancies; • Previouw perinatal complications; • Smoking: pack years.	—

Measure

Time frame

• Postpartum weight retention, • Smoking cessation • Dietary habits: 7 day food diary, Three Factor Eating Questionnaire (TFEQ) • Physical activity habits: accelerometry, Baecke questionnaire • Miscarriage: defined as the loss of the fetus before the 20th week of pregnancy. • Pregnancy complications • Vitamin D status: • Childbirth complications • Dysmaturity and macrosomia • Prematurity • Metabolic derangement: blood glucose levels, insulin resistance (HOMA-IR), lipid profile and liver enzymes, OGTT . • Cardiovascular alterations: blood pressure (BP) and pulse wave velocity (PWV), arteriovenous ratio (AV-ratio) derived from retina image. • Microbial flora of the mother(fecal, vaginal, oral) and child (fecal) • Epigenetics (biopsy placenta) • Cord blood glucose, insulin and lipids • Metabolic derangement of the child: bloodglucose, insulin levels and lipid profile of the infants at 1y. • Breast milk composition • Body composition (deuterium method) • Marital status; • Education; • Medical history; • Number of previous pregnancies; • Previouw perinatal complications; • Smoking: pack years.

—

Contacts

Public ContactDorien Reijnders

Maastricht University Medical Center+

dorien.reijnders@mumc.nl0433874173

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)