TOP-mums, for a Healthy Start

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02703753
• Other study ID #: METC152026
• Status: Terminated
• Phase: N/A
• Start date: July 27, 2016
• Est. completion date: April 22, 2024

Study information

• Verified date: May 2024
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 76
• Est. completion date: April 22, 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Pregnancy Complications

Intervention

Behavioral:
• Lifestyle intervention
The investigational treatment consists of a lifestyle intervention targeting on a healthy diet, physical activity and, if applicable, smoking cessation.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in body weight		From baseline to 6 weeks postpartum
Secondary	Gestational weight gain		6 weeks of gestational age to 36 weeks of gestational age
Secondary	Postpartum weight retention		6 weeks of gestational age to 6 months postpartum
Secondary	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.
Secondary	Biochemical verification of tobacco use	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.	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.
Secondary	Dietary habits	By a food diary and the three factor eating questionnaire.	Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.
Secondary	Physical activity habits	By an accelerometer and the Baecke questionnaire.	Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.
Secondary	Miscarriage		During pregnancy: at 6, 12 and 20 weeks of gestational age.
Secondary	Time to pregnancy		From pregnancy wish to first day of last menstruation
Secondary	Pregnancy complications	Gestational diabetes mellitus, pregnancy-induced hypertension, preeclampsia.	At birth
Secondary	Delivery complications	Caesarean section, induction of labour, vacuum extraction, postpartum haemorrhage, maternal hospital stay, shoulder dystocia.	At birth
Secondary	Vitamin D status		Will be measured at baseline and at 32 weeks of gestational age.
Secondary	Dysmaturity and macrosomia		At birth
Secondary	Prematurity	Birth before 37 weeks of gestational age	At birth
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Fat mass and fatt free mass	Body composition will be measured using the deuterium dilution method	Will be measured at baseline, at 32 weeks of gestational age during pregnancy and 6 months postpartum
Secondary	Fasting glucose level of the child		At birth and 12 months postpartum
Secondary	Fasting insulin level of the child		At birth and 12 months postpartum
Secondary	Insulin resistance (HOMA-IR) of the child		At birth and 12 months postpartum
Secondary	Total cholesterol of the child		At birth and 12 months postpartum
Secondary	LDL cholesterol of the child		At birth and 12 months postpartum
Secondary	HDL cholesterol of the child		At birth and 12 months postpartum
Secondary	Triglycerides of the child		At birth and 12 months postpartum
Secondary	Free fatty acids of the child		At birth and 12 months postpartum
Secondary	Tidal volume of the child		Will be measured at 6 weeks and 12 months postpartum
Secondary	Respiratory rate of the child		Will be measured at 6 weeks and 12 months postpartum
Secondary	Respiratory system resistance of the child		Will be measured at 6 weeks and 12 months postpartum
Secondary	Respiratory system reactance of the child		Will be measured at 6 weeks and 12 months postpartum
Secondary	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
Secondary	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