Effect of the 'Mother and Baby' Program on Well-Being - Full Text View

Purpose

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	Intervention	Phase
Postnatal Depression	Behavioral: Exercise and education Behavioral: Education	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Effect of the 'Mother and Baby' Program on New Mothers' Psychological and Physical Well-Being.

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Postpartum Depression

U.S. FDA Resources

Further study details as provided by University of Melbourne:

Primary Outcome Measures:

Affect Balance Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Edinburgh Postnatal Depression Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Exercise level [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]


Enrollment:	160
Study Start Date:	July 2005
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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Eligibility


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy women giving birth at the Angliss Hospital (primiparous and multiparous)

Exclusion Criteria:

Previous history of postnatal depression

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361478

Locations


Australia, Victoria
The Angliss Hospital
Ferntree Gully, Victoria, Australia, 3156

Sponsors and Collaborators

University of Melbourne

Investigators


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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Dr Mary Galea, The University of Melbourne
ClinicalTrials.gov Identifier:	NCT00361478 History of Changes
Other Study ID Numbers:	07/2004
Study First Received:	August 7, 2006
Last Updated:	August 11, 2008
Health Authority:	Australia: National Health and Medical Research Council

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

ClinicalTrials.gov processed this record on September 30, 2016