Postnatal DepressionPhase 3NCT00361478
Effect of the 'Mother and Baby' Program on Well-Being
A Phase 3 study testing Exercise and education and Education in people with Postnatal Depression, run by University of Melbourne at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postnatal Depression
- What is being tested?
- Exercise and education and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2005to Aug 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women giving birth at the Angliss Hospital (primiparous and multiparous)
Who cannot join
- Previous history of postnatal depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postnatal Depression
- Being tested
- Exercise and education, Education
- Keywords
- exercise, postnatal depression, psychological health, well-being
- Medical subject headings
- Depression, Postpartum, Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and educationBehavioural
Also called Exercise
Weekly exercise and education program for 8 weeks
EducationBehavioural
Also called Educational material
Written educational material
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | "Mother and Baby" Program comprising exercise and education. Receives: Behavioral: Exercise and education |
| 2 | Active comparator | Education only Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affect Balance Scale
Measured: 4 weeks
Secondary outcomes (2)
Edinburgh Postnatal Depression Scale
Measured: 4 weeks
Exercise level
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startJul 2005
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postnatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Investigators
- Mary P Galea, PhD, Study director, University of MelbourneEmily Ashby, BPhysio, Principal investigator, The Angliss HospitalMargaret Sherburn, MWHlth, Principal investigator, University of MelbourneRichard Osborne, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361478
- Sponsor's protocol ID
- 07/2004
- Status last verified
- Jul 2006
- First submitted
- 7 Aug 2006
- Last updated
- 13 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20056720
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the 'Mother and Baby' Program on New Mothers' Psychological and Physical Well-Being.
- ClinicalTrials.gov ID
- NCT00361478
- Acronym / sponsor ID
- 07/2004
- Conditions
- Postnatal Depression
- Keywords
- exercise, postnatal depression, psychological health, well-being
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 8 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Exercise and education"Mother and Baby" Program comprising exercise and education. |
| 2 | Active comparator | Behavioral: EducationEducation only |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy women giving birth at the Angliss Hospital (primiparous and multiparous)
Key exclusion criteria (1 listed)
- Previous history of postnatal depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and educationAlso: ExerciseWeekly exercise and education program for 8 weeks | Behavioural | 1 |
| EducationAlso: Educational materialWritten educational material | Behavioural | 2 |
Primary outcome
Affect Balance Scale
Time frame: 4 weeks
2 secondary outcomes
Edinburgh Postnatal Depression Scale
Time frame: 4 weeks
Exercise level
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2008.
- Derived from this study: PubMed 20056720Norman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary P Galea, PhD study director
University of Melbourne
Emily Ashby, BPhysio principal investigator
The Angliss Hospital
Margaret Sherburn, MWHlth principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise and education and Education in people with Postnatal Depression, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affect Balance Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00361478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2008.