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

This study has been completed.
Sponsor:
Information provided by:
University of Melbourne
ClinicalTrials.gov Identifier:
NCT00361478
First received: August 7, 2006
Last updated: August 11, 2008
Last verified: July 2006
History of Changes
  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:

  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 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:

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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
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
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 The University of MELBOURNE
Principal Investigator: Emily Ashby, BPhysio The Angliss Hospital
Principal Investigator: Margaret Sherburn, MWHlth The University of Melbourne
Principal Investigator: Richard Osborne, PhD The University of Melbourne
  More Information

No publications provided by University of Melbourne

Additional 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
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
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on May 23, 2013