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TOP-mums, for a Healthy Start

15 de julio de 2020 actualizado por: Maastricht University Medical Center

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.

Descripción general del estudio

Estado

Desconocido

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

112

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Anita Vreugdenhil, MD, PhD
  • Número de teléfono: +31 43 38 75284
  • Correo electrónico: a.vreugdenhil@mumc.nl

Ubicaciones de estudio

    • Limburg
      • Maastricht, Limburg, Países Bajos, 6229HX
        • Reclutamiento
        • Maastricht University Medical Center
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 40 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
The investigational treatment consists of a lifestyle intervention targeting on a healthy diet, physical activity and, if applicable, smoking cessation.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Reduction in body weight
Periodo de tiempo: From baseline to 6 weeks postpartum
From baseline to 6 weeks postpartum

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Gestational weight gain
Periodo de tiempo: 6 weeks of gestational age to 36 weeks of gestational age
6 weeks of gestational age to 36 weeks of gestational age
Postpartum weight retention
Periodo de tiempo: 6 weeks of gestational age to 6 months postpartum
6 weeks of gestational age to 6 months postpartum
Smoking cessation
Periodo de tiempo: 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.
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
Periodo de tiempo: 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.
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
Periodo de tiempo: Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.
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
Periodo de tiempo: Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.
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
Periodo de tiempo: During pregnancy: at 6, 12 and 20 weeks of gestational age.
During pregnancy: at 6, 12 and 20 weeks of gestational age.
Time to pregnancy
Periodo de tiempo: From pregnancy wish to first day of last menstruation
From pregnancy wish to first day of last menstruation
Pregnancy complications
Periodo de tiempo: At birth
Gestational diabetes mellitus, pregnancy-induced hypertension, preeclampsia.
At birth
Delivery complications
Periodo de tiempo: At birth
Caesarean section, induction of labour, vacuum extraction, postpartum haemorrhage, maternal hospital stay, shoulder dystocia.
At birth
Vitamin D status
Periodo de tiempo: Will be measured at baseline and at 32 weeks of gestational age.
Will be measured at baseline and at 32 weeks of gestational age.
Dysmaturity and macrosomia
Periodo de tiempo: At birth
At birth
Prematurity
Periodo de tiempo: At birth
Birth before 37 weeks of gestational age
At birth
Fasting glucose level
Periodo de tiempo: 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.
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
Periodo de tiempo: 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.
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)
Periodo de tiempo: 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.
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
Periodo de tiempo: 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.
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
Periodo de tiempo: 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.
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
Periodo de tiempo: 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.
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
Periodo de tiempo: 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.
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
Periodo de tiempo: 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.
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
Periodo de tiempo: 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.
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
Periodo de tiempo: 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.
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
Periodo de tiempo: 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.
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
Periodo de tiempo: 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.
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
Periodo de tiempo: 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.
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
Periodo de tiempo: 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.
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
Periodo de tiempo: Will be measured at baseline, at 32 weeks of gestational age during pregnancy and 6 months postpartum
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
Periodo de tiempo: At birth and 12 months postpartum
At birth and 12 months postpartum
Fasting insulin level of the child
Periodo de tiempo: At birth and 12 months postpartum
At birth and 12 months postpartum
Insulin resistance (HOMA-IR) of the child
Periodo de tiempo: At birth and 12 months postpartum
At birth and 12 months postpartum
Total cholesterol of the child
Periodo de tiempo: At birth and 12 months postpartum
At birth and 12 months postpartum
LDL cholesterol of the child
Periodo de tiempo: At birth and 12 months postpartum
At birth and 12 months postpartum
HDL cholesterol of the child
Periodo de tiempo: At birth and 12 months postpartum
At birth and 12 months postpartum
Triglycerides of the child
Periodo de tiempo: At birth and 12 months postpartum
At birth and 12 months postpartum
Free fatty acids of the child
Periodo de tiempo: At birth and 12 months postpartum
At birth and 12 months postpartum
Tidal volume of the child
Periodo de tiempo: Will be measured at 6 weeks and 12 months postpartum
Will be measured at 6 weeks and 12 months postpartum
Respiratory rate of the child
Periodo de tiempo: Will be measured at 6 weeks and 12 months postpartum
Will be measured at 6 weeks and 12 months postpartum
Respiratory system resistance of the child
Periodo de tiempo: Will be measured at 6 weeks and 12 months postpartum
Will be measured at 6 weeks and 12 months postpartum
Respiratory system reactance of the child
Periodo de tiempo: Will be measured at 6 weeks and 12 months postpartum
Will be measured at 6 weeks and 12 months postpartum
Endothelial vasodilatation of the child: Percentage change between baseline and maximum perfusion acetylcholine
Periodo de tiempo: Will be measured at 6 weeks and 3 and 12 months postpartum
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
Periodo de tiempo: Will be measured at 6 weeks and 3 and 12 months postpartum
Will be measured at 6 weeks and 3 and 12 months postpartum

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Anita Vreugdenhil, MD, PhD, Maastricht UMC+
  • Silla de estudio: Luc Zimmermann, Prof, MD, Maastricht UMC+

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

27 de julio de 2016

Finalización primaria (Anticipado)

1 de diciembre de 2020

Finalización del estudio (Anticipado)

1 de diciembre de 2021

Fechas de registro del estudio

Enviado por primera vez

25 de febrero de 2016

Primero enviado que cumplió con los criterios de control de calidad

3 de marzo de 2016

Publicado por primera vez (Estimar)

9 de marzo de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de julio de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

15 de julio de 2020

Última verificación

1 de junio de 2020

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • METC152026

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Lifestyle intervention

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