TOP-mums, for a Healthy Start

Study 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.

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

Conditions
-----------------
Overweight, Obesity, Pregnancy Complications

Intervention / Treatment
-----------------
* Behavioral: Lifestyle intervention


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Behavioral: Lifestyle intervention<br>* The investigational treatment consists of a lifestyle intervention targeting on a healthy diet, physical activity and, if applicable, smoking cessation.<br>|
| No Intervention: Control group<br>The control group will receive usual care, including standard lifestyle advices during consultation with the GP, midwife, obstetrician or at the child well being centre. Furthermore, the control group will receive 1 recipe for a healthy meal per week. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in body weight |  | From baseline to 6 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain |  | 6 weeks of gestational age to 36 weeks of gestational age | 
| Postpartum weight retention |  | 6 weeks of gestational age to 6 months postpartum | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| Miscarriage |  | During pregnancy: at 6, 12 and 20 weeks of gestational age. | 
| Time to pregnancy |  | From pregnancy wish to first day of last menstruation | 
| Pregnancy complications | Gestational diabetes mellitus, pregnancy-induced hypertension, preeclampsia. | At birth | 
| Delivery complications | Caesarean section, induction of labour, vacuum extraction, postpartum haemorrhage, maternal hospital stay, shoulder dystocia. | At birth | 
| Vitamin D status |  | Will be measured at baseline and at 32 weeks of gestational age. | 
| Dysmaturity and macrosomia |  | At birth | 
| Prematurity | Birth before 37 weeks of gestational age | At birth | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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 | 
| Fasting glucose level of the child |  | At birth and 12 months postpartum | 
| Fasting insulin 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 | 
| LDL cholesterol of the child |  | At birth and 12 months postpartum | 
| HDL cholesterol of the child |  | At birth 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 | 
| Tidal volume of the child |  | Will be measured at 6 weeks and 12 months postpartum | 
| Respiratory rate of the child |  | Will be measured at 6 weeks and 12 months postpartum | 
| Respiratory system resistance 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 acetylcholine |  | Will be measured at 6 weeks and 3 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 |