Clinical trial NCT02703753: TOP-mums, for a Healthy Start
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overweight
Obesity
Pregnancy Complications
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Reduction in body weight
timeFrame: From baseline to 6 weeks postpartum
Secondary outcomes:
measure: Gestational weight gain
timeFrame: 6 weeks of gestational age to 36 weeks of gestational age
measure: Postpartum weight retention
timeFrame: 6 weeks of gestational age to 6 months postpartum
measure: Smoking cessation
timeFrame: 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.
measure: Biochemical verification of tobacco use
timeFrame: 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.
measure: Dietary habits
timeFrame: Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.
measure: Physical activity habits
timeFrame: Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.
measure: Miscarriage
timeFrame: During pregnancy: at 6, 12 and 20 weeks of gestational age.
measure: Time to pregnancy
timeFrame: From pregnancy wish to first day of last menstruation
measure: Pregnancy complications
timeFrame: At birth
measure: Delivery complications
timeFrame: At birth
measure: Vitamin D status
timeFrame: Will be measured at baseline and at 32 weeks of gestational age.
measure: Dysmaturity and macrosomia
timeFrame: At birth
measure: Prematurity
timeFrame: At birth
measure: Fasting glucose level
timeFrame: 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.
measure: Fasting insulin level
timeFrame: 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.
measure: Insuline resistance (HOMA-IR)
timeFrame: 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.
measure: Total cholesterol
timeFrame: 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.
measure: LDL cholesterol
timeFrame: 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.
measure: HDL cholesterol
timeFrame: 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.
measure: Triglycerides
timeFrame: 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.
measure: Free fatty acids
timeFrame: 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.
measure: Alkaline phosphatase
timeFrame: 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.
measure: Gamma-GT
timeFrame: 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.
measure: ASAT
timeFrame: 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.
measure: ALAT
timeFrame: 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.
measure: Blood pressure
timeFrame: 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.
measure: Pulse wave velocity
timeFrame: 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.
measure: Fat mass and fatt free mass
timeFrame: Will be measured at baseline, at 32 weeks of gestational age during pregnancy and 6 months postpartum
measure: Fasting glucose level of the child
timeFrame: At birth and 12 months postpartum
measure: Fasting insulin level of the child
timeFrame: At birth and 12 months postpartum
measure: Insulin resistance (HOMA-IR) of the child
timeFrame: At birth and 12 months postpartum
measure: Total cholesterol of the child
timeFrame: At birth and 12 months postpartum
measure: LDL cholesterol of the child
timeFrame: At birth and 12 months postpartum
measure: HDL cholesterol of the child
timeFrame: At birth and 12 months postpartum
measure: Triglycerides of the child
timeFrame: At birth and 12 months postpartum
measure: Free fatty acids of the child
timeFrame: At birth and 12 months postpartum
measure: Tidal volume of the child
timeFrame: Will be measured at 6 weeks and 12 months postpartum
measure: Respiratory rate of the child
timeFrame: Will be measured at 6 weeks and 12 months postpartum
measure: Respiratory system resistance of the child
timeFrame: Will be measured at 6 weeks and 12 months postpartum
measure: Respiratory system reactance of the child
timeFrame: Will be measured at 6 weeks and 12 months postpartum
measure: Endothelial vasodilatation of the child: Percentage change between baseline and maximum perfusion acetylcholine
timeFrame: Will be measured at 6 weeks and 3 and 12 months postpartum
measure: Endothelial vasodilatation of the child: Percentage change between baseline and maximum perfusion nitroprusside
timeFrame: Will be measured at 6 weeks and 3 and 12 months postpartum
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht UMC+
name: Anita Vreugdenhil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht UMC+
name: Luc Zimmermann, Prof, MD
role: STUDY_CHAIR
References:
citation: Timmermans YEG, van de Kant KDG, Reijnders D, Kleijkers LMP, Dompeling E, Kramer BW, Zimmermann LJI, Steegers-Theunissen RPM, Spaanderman MEA, Vreugdenhil ACE. Towards Prepared mums (TOP-mums) for a healthy start, a lifestyle intervention for women with overweight and a child wish: study protocol for a randomised controlled trial in the Netherlands. BMJ Open. 2019 Nov 19;9(11):e030236. doi: 10.1136/bmjopen-2019-030236.