TOwards Prepared Mums (TOP-mums), for a Healthy Start: A Lifestyle Intervention to Reduce Overweight and Smoking in Women With a Pregnancy Wish to Prevent Perinatal Morbidity

Maastricht University Medical Center1 site in 1 country76 target enrollmentJuly 27, 2016

ConditionsOverweight Obesity Pregnancy Complications

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Overweight
Sponsor: Maastricht University Medical Center
Enrollment: 76
Locations: 1
Primary Endpoint: Reduction in body weight
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study evaluates the effect of a lifestyle intervention for women with a pregnancy wish who have a high risk on perinatal morbidity because of overweight or obesity. Half of the patients will receive the lifestyle intervention while the other half will receive usual care. It is hypothesized that an effective lifestyle intervention directed towards healthy living, including reduction of overweight or obesity and, if applicable, smoking reduction, health problems in mothers and their offspring can be prevented.

Registry

clinicaltrials.gov

Start Date

July 27, 2016

End Date

April 22, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Maastricht University Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Women with a pregnancy wish within 1 year;
•Aged 18-40 years;
•Overweight/obesity (BMI ≥ 25 kg/m2).

Exclusion Criteria

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

Outcomes

Primary Outcomes

Reduction in body weight

Time Frame: From baseline to 6 weeks postpartum

Secondary Outcomes

HDL cholesterol of the child(At birth and 12 months postpartum)
Respiratory rate of the child(Will be measured at 6 weeks and 12 months postpartum)
Miscarriage(During pregnancy: at 6, 12 and 20 weeks of gestational age.)
Gestational weight gain(6 weeks of gestational age to 36 weeks of gestational age)
Delivery complications(At birth)
Gamma-GT(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
ALAT(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
LDL cholesterol of the child(At birth and 12 months postpartum)
Respiratory system resistance of the child(Will be measured at 6 weeks and 12 months postpartum)
Fasting insulin level(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
Postpartum weight retention(6 weeks of gestational age to 6 months postpartum)
Biochemical verification of tobacco use(Baseline. Prepregnancy: after 1, 2, 3, 6, 9 and 12 months. During pregnancy: at 6,12,20,32,36 and 40 weeks of gestational age. Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.)
Dietary habits(Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.)
Physical activity habits(Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.)
Vitamin D status(Will be measured at baseline and at 32 weeks of gestational age.)
Dysmaturity and macrosomia(At birth)
Smoking cessation(Baseline. Prepregnancy: after 1, 2, 3, 6, 9 and 12 months. During pregnancy: at 6,12,20,32,36 and 40 weeks of gestational age. Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.)
Insuline resistance (HOMA-IR)(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
Total cholesterol(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
Blood pressure(Will be measured at baseline; Prepregnancy: after 1, 2, 3, 6, 9 and 12 months; During pregnancy: at 6, 12, 20, 32, 36 and 40 weeks of gestational age; Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.)
Pulse wave velocity(Will be measured at baseline; Prepregnancy: after 3, 6 and 12 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: at 6 and 12 months.)
Time to pregnancy(From pregnancy wish to first day of last menstruation)
Fasting glucose level(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
LDL cholesterol(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
HDL cholesterol(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
Free fatty acids(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
ASAT(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
Fat mass and fatt free mass(Will be measured at baseline, at 32 weeks of gestational age during pregnancy and 6 months postpartum)
Fasting glucose level of the child(At birth and 12 months postpartum)
Fasting insulin level of the child(At birth and 12 months postpartum)
Pregnancy complications(At birth)
Prematurity(At birth)
Insulin resistance (HOMA-IR) of the child(At birth and 12 months postpartum)
Total cholesterol of the child(At birth and 12 months postpartum)
Triglycerides(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
Alkaline phosphatase(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
Tidal volume of the child(Will be measured at 6 weeks and 12 months postpartum)
Respiratory system reactance of the child(Will be measured at 6 weeks and 12 months postpartum)
Endothelial vasodilatation of the child: Percentage change between baseline and maximum perfusion nitroprusside(Will be measured at 6 weeks and 3 and 12 months postpartum)
Triglycerides of the child(At birth and 12 months postpartum)
Free fatty acids of the child(At birth and 12 months postpartum)
Endothelial vasodilatation of the child: Percentage change between baseline and maximum perfusion acetylcholine(Will be measured at 6 weeks and 3 and 12 months postpartum)