TOP-mums, for a Healthy Start

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

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 Overview

• Status: Terminated
• Conditions: Obesity; Overweight; Pregnancy Complications
• Intervention / Treatment: Behavioral: Lifestyle intervention

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229HX
      • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; The investigational treatment consists of a lifestyle intervention targeting on a healthy diet, physical activity and, if applicable, smoking cessation.
No Intervention: Control group; 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	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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Anita Vreugdenhil, MD, PhD, Maastricht UMC+; Study Chair: Luc Zimmermann, Prof, MD, Maastricht UMC+

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2016
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): April 22, 2024

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimated): March 9, 2016

Study Record Updates

• Last Update Posted (Estimated): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Overweight; Pregnancy Complications
• Other Study ID Numbers: METC152026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No