Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361478
Status:
COMPLETED
Last Update Posted:
2008-08-13
First Post:
2006-08-07
Brief Title:
Effect of the Mother and Baby Program on Well-Being
Sponsor:
University of Melbourne
Organization:
University of Melbourne
Study Overview
Official Title:
Effect of the Mother and Baby Program on New Mothers Psychological and Physical Well-Being
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study investigates the effect of the Mother and Baby MB program on the psychological health and well-being of new mothers 6-10 weeks following the birth of their baby The MB 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 MB program has a positive effect on new mothers psychological health and well-being
2 The MB program increases participation in regular physical activity
3 the MB program benefits first time mothers more than women who have had more than one child
1 The MB program has a positive effect on new mothers psychological health and well-being
2 The MB program increases participation in regular physical activity
3 the MB 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 MB 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 MB 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 RCTof the effects of the MB 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 MB 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 MB 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 MB 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 14 unit difference between the two groups An advantage of 14 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
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 MB 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 MB 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 RCTof the effects of the MB 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 MB 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 MB 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 MB 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 14 unit difference between the two groups An advantage of 14 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None