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. Identifier: NCT00361478
Recruitment Status : Completed
First Posted : August 8, 2006
Last Update Posted : August 13, 2008
Information provided by:
University of Melbourne

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.

Condition or disease Intervention/treatment Phase
Postnatal Depression Behavioral: Exercise and education Behavioral: Education Phase 3

  Show Detailed Description

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

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Affect Balance Scale [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Edinburgh Postnatal Depression Scale [ Time Frame: 4 weeks ]
  2. Exercise level [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00361478

Australia, Victoria
The Angliss Hospital
Ferntree Gully, Victoria, Australia, 3156
Sponsors and Collaborators
University of Melbourne
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 Identifier (NCT Number):
Responsible Party: Dr Mary Galea, The University of Melbourne 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:
postnatal depression
psychological health

Additional relevant MeSH terms:
Depression, Postpartum
Behavioral Symptoms
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders