TOP-mums, for a Healthy Start

Not Applicable

Terminated

• Conditions: Overweight; Obesity; Pregnancy Complications
• Interventions: Behavioral: Lifestyle intervention

• Registration Number: NCT02703753
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-09
• Study Start: 2016-07-27
• Primary Completion: 2023-12
• Study Completion: 2024-04-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Lifestyle intervention	The intervention is an integral and multidisciplinary lifestyle intervention consisting of a healthy diet, appropriate physical activity and, if applicable, smoking cessation, customised to the needs of the women.

Primary Outcome Measures

Name	Time	Method
Reduction in body weight	From baseline to 6 weeks postpartum

Secondary Outcome Measures

Name	Time	Method
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	Caesarean section, induction of labour, vacuum extraction, postpartum haemorrhage, maternal hospital stay, shoulder dystocia.
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
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.	The amount of carbon monoxice (CO) in exhaled breath will be measured using a CO monitor (piCO Baby Smokerlyzer®, Bedfont, Kent, United Kingdom). Biochemical verification will also be done by measurement of urine cotinine.
Dietary habits	Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.	By a food diary and the three factor eating questionnaire.
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.	By an accelerometer and the Baecke questionnaire.
Vitamin D status	Will be measured at baseline and at 32 weeks of gestational age.
Dysmaturity and macrosomia	At birth
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.
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.
Fasting insulin level of the child	At birth and 12 months postpartum
Pregnancy complications	At birth	Gestational diabetes mellitus, pregnancy-induced hypertension, preeclampsia.
Prematurity	At birth	Birth before 37 weeks of gestational age
Fat mass and fatt free mass	Will be measured at baseline, at 32 weeks of gestational age during pregnancy and 6 months postpartum	Body composition will be measured using the deuterium dilution method
Fasting glucose level of the child	At birth and 12 months postpartum
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

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands