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Effect of the 'Mother and Baby' Program on Well-Being
This study has been completed.
Sponsor:
University of Melbourne
Information provided by:
University of Melbourne
ClinicalTrials.gov Identifier:
NCT00361478
First received: August 7, 2006
Last updated: August 11, 2008
Last verified: July 2006
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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 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. |
Resource links provided by NLM:
Further study details as provided by University of Melbourne:
Primary Outcome Measures:
- Affect Balance Scale [ Time Frame: 4 weeks ]
Secondary Outcome Measures:
- Edinburgh Postnatal Depression Scale [ Time Frame: 4 weeks ]
- Exercise level [ Time Frame: 4 weeks ]
| 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 (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
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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
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):
| 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 |
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 19, 2017