Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001146684
Ethics application status
Approved
Date submitted
16/10/2014
Date registered
30/10/2014
Date last updated
10/01/2019
Date data sharing statement initially provided
10/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The M.A.D.A.M Study. Mediators of Activity and Depression Amongst Mums.
Scientific title
Antenatal Mediators of Postnatal Depression and Physical Activity: A Prospective Cohort Study
Secondary ID [1] 285509 0
None
Universal Trial Number (UTN)
Trial acronym
The M.A.D.A.M Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postpartum Depression 293303 0
Condition category
Condition code
Mental Health 293576 293576 0 0
Depression
Reproductive Health and Childbirth 293614 293614 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 293615 293615 0 0
Antenatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will participate in two data collection sessions conducted in their homes. Variables including demographic information, symptoms of postnatal depression, health related quality of life, emotional resilience, maternal social support, physical activity self-efficacy, social support for physical activity participation, ratio of perceived advantages and disadvantages of physical activity (decisional balance) will be collected by paper based measures. Biological markers of stress (including salivary cortisol and a-Amylase) and potential genetic markers of vulnerability to depression (serotonin transporter gene polymorphisms and reelin gene (RELN) polymorphisms) will be collected by a saliva and cheek cell sample respectively. Physical activity will be measured using an ActiGraph wGT3X-BT accelerometer worn by the participant for 7 days. All of these measures (excluding the genetic sample and demographic information) will be assessed at two time points; approximately 20 weeks gestation and three months postnatal. Participants will also be asked to allow researchers access to information relating to their labor and postnatal care using methods consistent with the NSW Midwives Data Collection Form.
Intervention code [1] 290447 0
Not applicable
Comparator / control treatment
As this is a observational study there is no control group for this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293387 0
Potential genetic markers of vulnerability to depression (serotonin transporter gene polymorphisms and reelin gene (RELN) polymorphisms). The serotonin transporter gene polymorphisms and reelin gene (RELN) polymorphisms will be collected via a cheek cell sample. Participants will be asked to swirl a sample of commercial mouthwash in their mouths and return the mouthwash to the specimen jar.
Timepoint [1] 293387 0
This specimen will be collected during the participants first data collection visit.
Primary outcome [2] 293388 0
Edinburgh Postnatal Depression Scale (Cox 1987).
Timepoint [2] 293388 0
The Edinburgh Postnatal Depression Scale will be administered at two time points- prior to giving birth at approximately 20 weeks gestation and 3 months post-partum.
Secondary outcome [1] 310910 0
Connor Davidson Resilience Questionnaire (Connor 2003)
Timepoint [1] 310910 0
As close to 20 weeks gestation as possible and three months postnatal.
Secondary outcome [2] 310911 0
Short Form 12- Health Related Quality of Life (Lee 2007)
Timepoint [2] 310911 0
As close to 20 weeks gestation as possible and three months postnatal.
Secondary outcome [3] 310912 0
Zung Depression Scale (Zung 1965)
Timepoint [3] 310912 0
As close to 20 weeks gestation as possible and three months postnatal.
Secondary outcome [4] 310913 0
Medical Outcomes Study Social Support Survey (Sherbourne and Stewart 1991)
Timepoint [4] 310913 0
As close to 20 weeks gestation as possible and three months postnatal.
Secondary outcome [5] 310914 0
Three mediators of physical activity participation will be assessed using three validated self-report measures. These measures include the: Marcus (1992) Decisional Balance Scale; Sallis (1987) Social Support Scale; and the Marcus (1992) Self-Efficacy Scale.
Timepoint [5] 310914 0
As close to 20 weeks gestation as possible and three months postnatal.
Secondary outcome [6] 310915 0
Biological markers of stress (including salivary cortisol and aAmylase)
Timepoint [6] 310915 0
As close to 20 weeks gestation as possible and three months postnatal.
Secondary outcome [7] 310916 0
Objectively measured physical activity using the ActiGraph wGT3X-BT. The monitor will be worn for 7 days at each time point comprising 5 weekdays and 2 weekend days. Outcome data includes counts per minutes and time spent in moderate to vigorous physical activity.
Timepoint [7] 310916 0
As close to 20 weeks gestation as possible and three months postnatal.
Secondary outcome [8] 310917 0
Demographic information including marital status; ethnicity; education; employment status; number of children and previous pregnancies; and history of mental illness will be collected by a questionnaire designed by research staff designed specifically for the study.
Timepoint [8] 310917 0
This information will only be collected once during the participants first data collection appointment.
Secondary outcome [9] 311003 0
Information regarding labour and post-natal care. Participants will be asked to provide information regarding their labour and post-natal care. This information will be collected in a manner consistent with the New South Wales Midwives Data Collection Form.
Timepoint [9] 311003 0
Three months postnatal.

Eligibility
Key inclusion criteria
Inclusion criteria include women aged 18-50 years and approximately 20 weeks pregnant.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include women not proficient in English at a level to complete research assessments and/or concerns regarding participation by a GP/ Obstetrician.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Relationships between measured variables at each time point will be assessed using standard statistical techniques (e.g. Pearson correlation, Fishers Z score). Multiple regression analyses will be used to determine psychosocial and biological antenatal predictors (absolute and relative changes from pre to postnatal) of postnatal physical activity and symptoms of depression.

The sample number for this study was determined based on the sample available to researchers in the time frame applicable to the study. No clinical or statistical assumptions were used to determine the sample.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/08/2014
Actual
25/08/2014
Date of last participant enrolment
Anticipated
Actual
21/09/2018
Date of last data collection
Anticipated
Actual
21/12/2018
Sample size
Target
100
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 3050 0
Armidale Rural Referral Hospital - Armidale
Recruitment postcode(s) [1] 8823 0
2350 - Armidale

Funding & Sponsors
Funding source category [1] 290105 0
University
Name [1] 290105 0
2014 University Research Seed Grants/ University of New England
Country [1] 290105 0
Australia
Primary sponsor type
University
Name
University of New England
Address
C/- School of Science and Technology
University of New England
Armidale NSW 2350
Country
Australia
Secondary sponsor category [1] 288813 0
Hospital
Name [1] 288813 0
Hunter New England Local Health District Armidale Hospital Maternity Unit
Address [1] 288813 0
C/- Armidale Rural Referral Hospital
Rusden Street
Armidale NSW 2350
Country [1] 288813 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291813 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 291813 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 291813 0
Australia
Date submitted for ethics approval [1] 291813 0
Approval date [1] 291813 0
20/01/2014
Ethics approval number [1] 291813 0
13/12/11/4.10
Ethics committee name [2] 291814 0
University of New England’s Human Research Ethics Committee
Ethics committee address [2] 291814 0
Research Ethics Officer
Research Services
University of New England
Armidale NSW 2351
Ethics committee country [2] 291814 0
Australia
Date submitted for ethics approval [2] 291814 0
Approval date [2] 291814 0
17/09/2014
Ethics approval number [2] 291814 0
HNE-522
Ethics committee name [3] 296689 0
Griffith University Human Research Ethics Committee
Ethics committee address [3] 296689 0
Office for Research
Bray Centre,
170 Kessels Rd,
Nathan Campus,
Nathan QLD 4111
Griffith University
Ethics committee country [3] 296689 0
Australia
Date submitted for ethics approval [3] 296689 0
17/11/2016
Approval date [3] 296689 0
20/12/2016
Ethics approval number [3] 296689 0
GU Ref No: 2016/896

Summary
Brief summary
Postpartum depression (PPD) is characterised by low mood, irritability, fatigue, insomnia, change in appetite, anxiety, guilt, feelings relating to an inability to cope and worthlessness and thoughts of suicide. Postpartum depression (PPD) is estimated to affect 8-25% of women in the first 36 months after giving birth. Currently, psychosocial assessments (interview) and depression screening (self report questionnaire) during the perinatal period is routine clinical practice in New South Wales. Assessments aim to identify psychosocial risk factors for poor postnatal mental health (e.g. lack of support or recent stressors). There is little information regarding the genetic or biological indicators of PPD. Postpartum depression can have serious and prolonged effects on the mental and physical health of both the mother and child. Current studies support the positive influence of physical activity for treating PPD. This project aims to investigate the antenatal predictors of PPD and physical activity in adult women residing in the New England region. The aims of this research project are threefold: 1) To determine if there is an association with genetic variation and the incidence of PPD; 2) To evaluate the relationship between genetic variation and physical activity participation and; 3) To determine the relationship between theory driven predictors of physical activity and postpartum physical activity participation in women who live in rural areas. Variables including demographic information, medical information relating to pregnancy and labour, symptoms of postnatal depression, health related quality of life, emotional resilience, maternal social support, objectively measured physical activity, physical activity self-efficacy, social support for physical activity participation, ratio of perceived advantages and disadvantages of physical activity (decisional balance), biological markers of stress (including salivary cortisol and aAmylase) and potential genetic markers of vulnerability to depression (serotonin transporter gene polymorphisms and reelin gene (RELN) polymorphisms) will be assessed at two time points; participants second antenatal clinic visit (approximately 20 weeks gestation) and three months postnatal. Relationships between measured variables at each time point will be assessed using standard statistical techniques (e.g. Pearson correlation, Fishers Z score). Multiple regression analyses will be used to determine psychosocial and biological antenatal predictors (absolute and relative changes from pre to postnatal) of postnatal physical activity and symptoms of depression. The project outcomes aim to provide a mechanism for improved screening, contribute to the research relating to the prevention of PPD, and evaluate the predictors of physical activity.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes
n/a
Attachments [1] 209 209 0 0
/AnzctrAttachments/367271-MADAM_Recruitment Flier.pdf
Attachments [2] 1374 1374 0 0
/AnzctrAttachments/367271-MADAM_Recruitment Flier_QLD.pdf (Supplementary information)

Contacts
Principal investigator
Name 52142 0
Dr Kelly Clanchy
Address 52142 0
C/- School of Science and Technology
University of New England
Armidale NSW 2350
Country 52142 0
Australia
Phone 52142 0
+61 2 67734511 (NSW) / +61 7 5552-7006 (QLD)
Fax 52142 0
n/a
Email 52142 0
[email protected]
Contact person for public queries
Name 52143 0
Kelly Clanchy
Address 52143 0
C/- School of Science and Technology
University of New England
Armidale NSW 2350
Country 52143 0
Australia
Phone 52143 0
+61 7 5552-7006 (QLD)
Fax 52143 0
n/a
Email 52143 0
[email protected]
Contact person for scientific queries
Name 52144 0
Kelly Clanchy
Address 52144 0
C/- School of Science and Technology
University of New England
Armidale NSW 2350
Country 52144 0
Australia
Phone 52144 0
+61 7 5552-7006 (QLD)
Fax 52144 0
n/a
Email 52144 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval does not cover IPD sharing.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.