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Clinical Trials/NCT02703753
NCT02703753TerminatedNot Applicable

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 enrollmentStarted: July 27, 2016Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
76
Locations
1
Primary Endpoint
Reduction in body weight
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Intervention group

Experimental

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.

Intervention: Lifestyle intervention (Behavioral)

Control group

No Intervention

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.

Outcomes

Primary Outcomes

Reduction in body weight

Time Frame: From baseline to 6 weeks postpartum

Secondary Outcomes

  • 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)
  • Triglycerides of the child(At birth and 12 months postpartum)
  • 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)
  • 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)
  • 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.)
  • Pregnancy complications(At birth)
  • Prematurity(At birth)
  • 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)
  • 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)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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