- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00361478
Effect of the 'Mother and Baby' Program on Well-Being
Effect of the 'Mother and Baby' Program on New Mothers' Psychological and Physical Well-Being.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Victoria
-
Ferntree Gully, Victoria, Australia, 3156
- The Angliss Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy women giving birth at the Angliss Hospital (primiparous and multiparous)
Exclusion Criteria:
- Previous history of postnatal depression
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
Education only
|
Written educational material
Other Names:
|
Experimental: 1
"Mother and Baby" Program comprising exercise and education.
|
Weekly exercise and education program for 8 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Affect Balance Scale
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Edinburgh Postnatal Depression Scale
Time Frame: 4 weeks
|
4 weeks
|
Exercise level
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
Sponsor
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07/2004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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