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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00361478
Registration number
NCT00361478
Ethics application status
Date submitted
7/08/2006
Date registered
8/08/2006
Date last updated
13/08/2008
Titles & IDs
Public title
Effect of the 'Mother and Baby' Program on Well-Being
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Scientific title
Effect of the 'Mother and Baby' Program on New Mothers' Psychological and Physical Well-Being.
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Secondary ID [1]
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07/2004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postnatal Depression
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Condition category
Condition code
Mental Health
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Depression
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Reproductive Health and Childbirth
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Childbirth and postnatal care
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - Exercise and education
Behaviour - Education
Experimental: 1 - "Mother and Baby" Program comprising exercise and education.
Active Comparator: 2 - Education only
Behaviour: Exercise and education
Weekly exercise and education program for 8 weeks
Behaviour: Education
Written educational material
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Affect Balance Scale
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Assessment method [1]
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Timepoint [1]
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4 weeks
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Secondary outcome [1]
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Edinburgh Postnatal Depression Scale
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Assessment method [1]
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Timepoint [1]
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4 weeks
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Secondary outcome [2]
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Exercise level
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Assessment method [2]
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Timepoint [2]
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4 weeks
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Eligibility
Key inclusion criteria
- Healthy women giving birth at the Angliss Hospital (primiparous and multiparous)
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Previous history of postnatal depression
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2006
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Sample size
Target
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Accrual to date
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Final
160
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Angliss Hospital - Ferntree Gully
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Recruitment postcode(s) [1]
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3156 - Ferntree Gully
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00361478
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mary P Galea, PhD
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Address
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University of Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00361478
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