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Effect of the 'Mother and Baby' Program on Well-Being

11 de agosto de 2008 actualizado por: University of Melbourne

Effect of the 'Mother and Baby' Program on New Mothers' Psychological and Physical Well-Being.

The study investigates the effect of the 'Mother and Baby' (M&B) program on the psychological health and well-being of new mothers 6-10 weeks following the birth of their baby. The M&B program is an 8-week program of group exercise and education sessions provided by various health professionals. The design of the study is a comprehensive cohort design, including a randomised controlled trial. The primary outcome measure is the Affect Balance Scale. The hypotheses are:

  1. The M&B program has a positive effect on new mothers' psychological health and well-being.
  2. The M&B program increases participation in regular physical activity.
  3. the M&B program benefits first time mothers more than women who have had more than one child.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Background

The benefits of exercise, in particular group exercise, for women in early motherhood include improved body image, decreased anxiety, improved energy and building of social networks. Exercise has also been shown to be beneficial in the management of mood disorders such as depression and more specifically, postnatal depression. However there has been no suggestion that exercise may reduce symptoms of psychotic disorders that require medication, psychiatric therapy and possible hospitalisation. The number of women experiencing postnatal depression (PND) has increased to one in five women following childbirth. Some of the risks of development of PND include lack of social support during the childbearing year and lack of involvement in the community. new mothers have identified that reasons for inactivity include no child care, limited opportunity to exercise with their baby, reduced self-esteem, poor body image, or they are too busy. Research to date is limited and qualitative in nature, with no standardised measurement tools used to assess quality of life in postnatal women.

The 'Mother and Baby' (M&B) program is an 8-week program involving one hour of group exercise with mothers and their babies conducted by a physiotherapist and a 30-minute education session provided by various health professionals (physiotherapist, nutritionist, speech pathologist, psychologists and midwives). Education topics include baby massage, nutrition for mothers, introducing solids, adjusting to a new lifestyle, communicating with the baby, sun care for the baby and play development. The aim of the study is to explore the benefits of the M&B program on new mothers' psychological and physical well-being as well as the social benefits of exercise.

Research Plan

The design of the study is a comprehensive cohort design incorporating a randomised controlled trial (RCT)of the effects of the M&B program on the health of health women 6-10 weeks following the birth of their baby. The cohort design will complement the results of a classic RCT by allowing the investigation of outcomes in a setting that simulates the 'real-world' treatment process.

Women who have had their babies at the Angliss Hospital and are ready for discharge will be invited to participate in the study. Potential participants will be asked if they have a preference for the M&B program or Education sessions only, or if they would be willing to be part of an RCT. Those who agree to be part of the RCT will be randomised to M&B or Education only sessions. Allocation will be controlled by the chief investigator and will be concealed, with codes placed in opaque sealed enveloped. Randomisation will be stratified according to parity (first time mothers vs multiparous) and blocked in groups of 16.

All participants will receive and complete a questionnaire booklet and will return this in a pre-paid envelope. Questionnaires include:

  1. The Affect Balance Scale. This is the primary outcome measure. It is a highly reliable scale comprising ten questions indicating psychological reactions (positive and negative) to events in daily life.
  2. Edinburgh Postnatal Depression Scale. This is a widely used scale for the detection of risk factors for postnatal depression.
  3. Questions regarding exercise. Three questions regarding exercise will be asked and answers will be compared to tables of the number of metabolic equivalents (METS) required to perform the activity.
  4. Program evaluation. Participants undertaking the M&B program will complete a standardised evaluation form.

Sample size

A preliminary power calculation has been conducted from studies using the Affect Balance Scale in similar settings. With 80 subjects per group we will have 80% power to detect a 1.4 unit difference between the two groups. An advantage of 1.4 units (or 7% to 10% across a scale) is regarded as a clinically important difference. A pilot study will be undertaken to confirm the sample size.

Tipo de estudio

Intervencionista

Inscripción (Actual)

160

Fase

  • Fase 3

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.

Ubicaciones de estudio

    • Victoria
      • Ferntree Gully, Victoria, Australia, 3156
        • The Angliss Hospital

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 45 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Healthy women giving birth at the Angliss Hospital (primiparous and multiparous)

Exclusion Criteria:

  • Previous history of postnatal depression

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 2
Education only
Written educational material
Otros nombres:
  • Educational material
Experimental: 1
"Mother and Baby" Program comprising exercise and education.
Weekly exercise and education program for 8 weeks
Otros nombres:
  • Ejercicio

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Affect Balance Scale
Periodo de tiempo: 4 weeks
4 weeks

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Edinburgh Postnatal Depression Scale
Periodo de tiempo: 4 weeks
4 weeks
Exercise level
Periodo de tiempo: 4 weeks
4 weeks

Colaboradores e Investigadores

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

Investigadores

  • Director de estudio: Mary P Galea, PhD, University of Melbourne
  • Investigador principal: Emily Ashby, BPhysio, The Angliss Hospital
  • Investigador principal: Margaret Sherburn, MWHlth, University of Melbourne
  • Investigador principal: Richard Osborne, PhD, University of Melbourne

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

1 de julio de 2005

Finalización primaria (Actual)

1 de agosto de 2006

Finalización del estudio (Actual)

1 de agosto de 2006

Fechas de registro del estudio

Enviado por primera vez

7 de agosto de 2006

Primero enviado que cumplió con los criterios de control de calidad

7 de agosto de 2006

Publicado por primera vez (Estimar)

8 de agosto de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

13 de agosto de 2008

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

11 de agosto de 2008

Última verificación

1 de julio de 2006

Más información

Términos relacionados con este estudio

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 Depresion postnatal

Ensayos clínicos sobre Exercise and education

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