ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by:
University of Melbourne

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous history of postnatal depression
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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