Effect of the 'Mother and Baby' Program on Well-Being
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00361478 |
Recruitment Status
:
Completed
First Posted
: August 8, 2006
Last Update Posted
: August 13, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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:
- The M&B program has a positive effect on new mothers' psychological health and well-being.
- The M&B program increases participation in regular physical activity.
- the M&B program benefits first time mothers more than women who have had more than one child.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postnatal Depression | Behavioral: Exercise and education Behavioral: Education | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Effect of the 'Mother and Baby' Program on New Mothers' Psychological and Physical Well-Being. |
Study Start Date : | July 2005 |
Actual Primary Completion Date : | August 2006 |
Actual Study Completion Date : | August 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
"Mother and Baby" Program comprising exercise and education.
|
Behavioral: Exercise and education
Weekly exercise and education program for 8 weeks
Other Name: Exercise
|
Active Comparator: 2
Education only
|
Behavioral: Education
Written educational material
Other Name: Educational material
|
- Affect Balance Scale [ Time Frame: 4 weeks ]
- Edinburgh Postnatal Depression Scale [ Time Frame: 4 weeks ]
- Exercise level [ Time Frame: 4 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy women giving birth at the Angliss Hospital (primiparous and multiparous)
Exclusion Criteria:
- Previous history of postnatal depression

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00361478
Australia, Victoria | |
The Angliss Hospital | |
Ferntree Gully, Victoria, Australia, 3156 |
Study Director: | Mary P Galea, PhD | University of Melbourne | |
Principal Investigator: | Emily Ashby, BPhysio | The Angliss Hospital | |
Principal Investigator: | Margaret Sherburn, MWHlth | University of Melbourne | |
Principal Investigator: | Richard Osborne, PhD | University of Melbourne |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dr Mary Galea, The University of Melbourne |
ClinicalTrials.gov Identifier: | NCT00361478 History of Changes |
Other Study ID Numbers: |
07/2004 |
First Posted: | August 8, 2006 Key Record Dates |
Last Update Posted: | August 13, 2008 |
Last Verified: | July 2006 |
Keywords provided by University of Melbourne:
exercise postnatal depression psychological health well-being |
Additional relevant MeSH terms:
Depression Depression, Postpartum Behavioral Symptoms Puerperal Disorders |
Pregnancy Complications Depressive Disorder Mood Disorders Mental Disorders |