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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Australia1 site
  • The Angliss Hospital

    Ferntree Gully, Victoria, 3156

Other trials in Australia

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:

  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.
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:

  1. 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.
  2. Edinburgh Postnatal Depression Scale. This is a widely used scale for the detection of risk factors for postnatal depression.
  3. 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.
  4. 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.

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 groups in NCT00361478
Study groupRoleWhat they receive
1Experimental"Mother and Baby" Program comprising exercise and education.
Receives: Behavioral: Exercise and education
2Active comparatorEducation only
Receives: Behavioral: Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Affect Balance Scale

    Measured: 4 weeks

Secondary outcomes (2)
  1. Edinburgh Postnatal Depression Scale

    Measured: 4 weeks

  2. 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.

  1. First posted8 Aug 2006 (estimated)
  2. Study startJul 2005
  3. Primary completionAug 2006
  4. Study completionAug 2006

Resources

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)
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

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; AzTrials last refreshed its copy on 7 Nov 2026.

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