Study Results
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Basic Information
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COMPLETED
PHASE3
160 participants
INTERVENTIONAL
2005-07-31
2006-08-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1
"Mother and Baby" Program comprising exercise and education.
Exercise and education
Weekly exercise and education program for 8 weeks
2
Education only
Education
Written educational material
Interventions
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Exercise and education
Weekly exercise and education program for 8 weeks
Education
Written educational material
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
FEMALE
Yes
Sponsors
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University of Melbourne
OTHER
Responsible Party
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The University of Melbourne
Principal Investigators
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Mary P Galea, PhD
Role: STUDY_DIRECTOR
University of Melbourne
Emily Ashby, BPhysio
Role: PRINCIPAL_INVESTIGATOR
The Angliss Hospital
Margaret Sherburn, MWHlth
Role: PRINCIPAL_INVESTIGATOR
University of Melbourne
Richard Osborne, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Melbourne
Locations
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The Angliss Hospital
Ferntree Gully, Victoria, Australia
Countries
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References
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Norman E, Sherburn M, Osborne RH, Galea MP. An exercise and education program improves well-being of new mothers: a randomized controlled trial. Phys Ther. 2010 Mar;90(3):348-55. doi: 10.2522/ptj.20090139. Epub 2010 Jan 7.
Other Identifiers
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07/2004
Identifier Type: -
Identifier Source: org_study_id