Effect of the 'Mother and Baby' Program on Well-Being
Primary Purpose
Postnatal Depression
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Exercise and education
Education
Sponsored by
About this trial
This is an interventional prevention trial for Postnatal Depression focused on measuring exercise, postnatal depression, psychological health, well-being
Eligibility Criteria
Inclusion Criteria: Healthy women giving birth at the Angliss Hospital (primiparous and multiparous) Exclusion Criteria: Previous history of postnatal depression
Sites / Locations
- The Angliss Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
"Mother and Baby" Program comprising exercise and education.
Education only
Outcomes
Primary Outcome Measures
Affect Balance Scale
Secondary Outcome Measures
Edinburgh Postnatal Depression Scale
Exercise level
Full Information
NCT ID
NCT00361478
First Posted
August 7, 2006
Last Updated
August 11, 2008
Sponsor
University of Melbourne
1. Study Identification
Unique Protocol Identification Number
NCT00361478
Brief Title
Effect of the 'Mother and Baby' Program on Well-Being
Official Title
Effect of the 'Mother and Baby' Program on New Mothers' Psychological and Physical Well-Being.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Melbourne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
Detailed Description
Background
The benefits of exercise, in particular group exercise, for women in early motherhood include improved body image, decreased anxiety, improved energy and building of social networks. Exercise has also been shown to be beneficial in the management of mood disorders such as depression and more specifically, postnatal depression. However there has been no suggestion that exercise may reduce symptoms of psychotic disorders that require medication, psychiatric therapy and possible hospitalisation. The number of women experiencing postnatal depression (PND) has increased to one in five women following childbirth. Some of the risks of development of PND include lack of social support during the childbearing year and lack of involvement in the community. new mothers have identified that reasons for inactivity include no child care, limited opportunity to exercise with their baby, reduced self-esteem, poor body image, or they are too busy. Research to date is limited and qualitative in nature, with no standardised measurement tools used to assess quality of life in postnatal women.
The 'Mother and Baby' (M&B) program is an 8-week program involving one hour of group exercise with mothers and their babies conducted by a physiotherapist and a 30-minute education session provided by various health professionals (physiotherapist, nutritionist, speech pathologist, psychologists and midwives). Education topics include baby massage, nutrition for mothers, introducing solids, adjusting to a new lifestyle, communicating with the baby, sun care for the baby and play development. The aim of the study is to explore the benefits of the M&B program on new mothers' psychological and physical well-being as well as the social benefits of exercise.
Research Plan
The design of the study is a comprehensive cohort design incorporating a randomised controlled trial (RCT)of the effects of the M&B program on the health of health women 6-10 weeks following the birth of their baby. The cohort design will complement the results of a classic RCT by allowing the investigation of outcomes in a setting that simulates the 'real-world' treatment process.
Women who have had their babies at the Angliss Hospital and are ready for discharge will be invited to participate in the study. Potential participants will be asked if they have a preference for the M&B program or Education sessions only, or if they would be willing to be part of an RCT. Those who agree to be part of the RCT will be randomised to M&B or Education only sessions. Allocation will be controlled by the chief investigator and will be concealed, with codes placed in opaque sealed enveloped. Randomisation will be stratified according to parity (first time mothers vs multiparous) and blocked in groups of 16.
All participants will receive and complete a questionnaire booklet and will return this in a pre-paid envelope. Questionnaires include:
The Affect Balance Scale. This is the primary outcome measure. It is a highly reliable scale comprising ten questions indicating psychological reactions (positive and negative) to events in daily life.
Edinburgh Postnatal Depression Scale. This is a widely used scale for the detection of risk factors for postnatal depression.
Questions regarding exercise. Three questions regarding exercise will be asked and answers will be compared to tables of the number of metabolic equivalents (METS) required to perform the activity.
Program evaluation. Participants undertaking the M&B program will complete a standardised evaluation form.
Sample size
A preliminary power calculation has been conducted from studies using the Affect Balance Scale in similar settings. With 80 subjects per group we will have 80% power to detect a 1.4 unit difference between the two groups. An advantage of 1.4 units (or 7% to 10% across a scale) is regarded as a clinically important difference. A pilot study will be undertaken to confirm the sample size.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postnatal Depression
Keywords
exercise, postnatal depression, psychological health, well-being
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
"Mother and Baby" Program comprising exercise and education.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Education only
Intervention Type
Behavioral
Intervention Name(s)
Exercise and education
Other Intervention Name(s)
Exercise
Intervention Description
Weekly exercise and education program for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Education
Other Intervention Name(s)
Educational material
Intervention Description
Written educational material
Primary Outcome Measure Information:
Title
Affect Balance Scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale
Time Frame
4 weeks
Title
Exercise level
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy women giving birth at the Angliss Hospital (primiparous and multiparous)
Exclusion Criteria:
Previous history of postnatal depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary P Galea, PhD
Organizational Affiliation
University of Melbourne
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Emily Ashby, BPhysio
Organizational Affiliation
The Angliss Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margaret Sherburn, MWHlth
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Osborne, PhD
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Angliss Hospital
City
Ferntree Gully
State/Province
Victoria
ZIP/Postal Code
3156
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
20056720
Citation
Norman E, Sherburn M, Osborne RH, Galea MP. An exercise and education program improves well-being of new mothers: a randomized controlled trial. Phys Ther. 2010 Mar;90(3):348-55. doi: 10.2522/ptj.20090139. Epub 2010 Jan 7.
Results Reference
derived
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Effect of the 'Mother and Baby' Program on Well-Being
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