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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
  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:


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

ClinicalTrials.gov processed this record on November 27, 2014