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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
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
Sex
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
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2006
Sample size
Target
Accrual to date
Final
160
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/ct2/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