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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
Effect of the 'Mother and Baby' Program on New Mothers' Psychological and Physical Well-Being.
Secondary ID [1] 0 0
07/2004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postnatal Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Affect Balance Scale
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
Edinburgh Postnatal Depression Scale
Timepoint [1] 0 0
4 weeks
Secondary outcome [2] 0 0
Exercise level
Timepoint [2] 0 0
4 weeks

Eligibility
Key inclusion criteria
- Healthy women giving birth at the Angliss Hospital (primiparous and multiparous)
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Previous history of postnatal depression

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Angliss Hospital - Ferntree Gully
Recruitment postcode(s) [1] 0 0
3156 - Ferntree Gully

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00361478
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mary P Galea, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications