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Trial registered on ANZCTR


Registration number
ACTRN12618001453279
Ethics application status
Approved
Date submitted
27/07/2018
Date registered
29/08/2018
Date last updated
29/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mums on the Move Study: a pilot randomised controlled trial to evaluate the effectiveness of a physical activity program for women at risk of post-natal depression.
Scientific title
Improving postnatal mental health through a novel, theory-based, multi-component home-environment physical activity intervention: A pilot randomised controlled trial
Secondary ID [1] 295624 0
None
Universal Trial Number (UTN)
U1111-1217-8826
Trial acronym
MOTM
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Post natal depression 308832 0
Condition category
Condition code
Mental Health 307851 307851 0 0
Depression
Reproductive Health and Childbirth 308274 308274 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aims: The primary aim of the Mums on the Move study is to investigate the feasibility of a multi-component 12-week home-environment intervention delivered to mothers at risk of post natal depression (PND) for increasing physical activity, with the view of generating ideas of effect size and informing power calculations for a larger trial in future. The secondary aim is to examine changes in depressive symptoms as a result of participating in the intervention.

Participants: The intervention will target 62 (intervention group = 31, control group = 31) mothers living in Melbourne, who are 3-9 months postpartum, classified 'at-risk' of PND, i.e. those who score 10 or greater on the Edinburgh postnatal depression scale (Cox, Holden, and Sagovsky, 1987), and who do not currently own a treadmill or stationary bicycle.

Recruitment methods:
• Maternal Child Health Centres (MCHC): Presentations (and flyers) to parent groups.
• Website advertisements on Post and Antenatal Depression Association (PANDA), Beyond Blue
• Social media: Sponsored Facebook advertisements and use of Twitter
• Advertisements in local newspapers and at local services (e.g. GP offices, pharmacies)
• Snowball techniques

Consent: After completion of a short online screening survey, participants will receive a plain language statement and consent form. They will be required to return a signed, completed consent form, along with approval from their GP to participate in physical activity (via a GP consent form) to the research team.

Randomisation: After initial screening (and once consent forms are returned) women will be randomly assigned to either the behavioral intervention (n = 31) or control (n= 31) conditions by using a computer-generated block randomization sequence produced and implemented by a statistician that involves blocks of 2 and 4 in varying combinations. Level of education (completed tertiary education/not completed tertiary education) will be applied as a stratification variable during randomisation. To conceal allocation, the randomization sequence will be stored securely and separately from the participant database and will not accessible by investigators who are blinded to participant allocation. Only the statistician and project manager will be informed of the allocation and enrolment of participants.

Intervention: Once randomly allocated into the intervention group, participants will be provided with home exercise equipment (free treadmill/stationary bicycle hire), a logbook for goal setting and self-monitoring, access to an online blog (for social support) and low-intensity motivational material (web-app) for 12 weeks.

The 12-week PA program is theoretically underpinned, based on constructs of the social cognitive theory (described below) and key behaviour change principles. Materials have been developed and pilot tested, and include:

Construct 1 - Physical Environmental:
Free exercise equipment (e.g. treadmill/stationary bicycle hire) (12 weeks) and logbook for self-monitoring.

Construct 2 - Social:
Online blog (for social support and to share tips and ideas on how to get active) since emerging evidence suggests that social media forums may play a role in behaviour change. The online blog forum will be a private page and only participants who are enrolled in this study (in the intervention group), will be able to view this page. The project manager will monitor this forum for the duration of the study, and upon closing of the project, the online blog will be deleted.

The project manager will monitor participant comments to ensure the well-being of participants, and to remove any inappropriate comments. Participants will NOT be required to utilise the forum a minimum number of times, but may choose to post comments as frequently as they wish, and only if they wish to do so. If comment numbers are dwindling on the forum, the manager will make a new post reiterating material provided on the web application to continue to encourage participant use of the forum. The majority of topics covered will therefore be driven by the participants themselves.

At the conclusion of the 12 week intervention period, the total number of participant comments will be tallied, and content analysis will be performed to determine the proportion of comments relating directly to the intervention.

Construct 3 - Intrapersonal:
Web-app (e-health) with written PA program tailored to current activity levels (beginner, intermediate, and advanced, and includes 30 minutes of continuous or interval aerobic exercise including warm up and cool down, performed on either a treadmill or stationary bicycle prescribed by the researchers), goal setting information, self-monitoring, motivational information, tips for overcoming barriers to be active and reduce sedentary behaviours (SB). The information provided on the app is a modified version of the web app designed by Teychenne et al. (2018), with additional materials designed specifically for this study. Participants will also be able to access free purposively designed music workout mixes on Spotify, as created by participants according to their music preferences.

To determine adherence to the app, the intervention group will be asked at follow up to self-report how often they used the web-app.

Data collection:
Prior to commencing the intervention period, the intervention group will complete a baseline survey about key study outcomes, including feasibility; objectively (via accelerometer) and self-measured PA and SB; depressive symptoms; theoretical constructs of behaviour change; and mediators. Physical activity will be objectively measured by an accelerometer worn for one week.

At Weeks 4 and 8, participants will be contacted via phone to monitor their depressive symptoms, and self-reported physical activity levels and sedentary behaviour.
Upon program completion (after 12 weeks), participants will complete a follow-up survey about key study outcomes as detailed above, and will again wear an accelerometer for one week.

Cox, Holden, and Sagovsky (1987). Detection of postnatal depression: development of the 10-item Edinburgh Postnatal Depression scale. Brit J Psych, 150(June):782-786.

Teychenne, et al (2018). Feasibility and acceptability of a home-based physical activity program for postnatal women with depressive symptoms: a pilot study. Mental Health and Phys Act, 14:82-89.
Intervention code [1] 301930 0
Prevention
Intervention code [2] 301931 0
Behaviour
Comparator / control treatment
Control group: Participants in the control group will receive access to the web-app and contact details for the equipment hire company (should they wish to hire exercise equipment in future – using their own money) after the 12-week intervention has been completed.

Data collection: Prior to commencing the intervention period, the intervention group will complete a baseline survey about key study outcomes, including feasibility; objectively (via accelerometer) and self-measured PA and SB; depressive symptoms; theoretical constructs of behaviour change; and mediators. Physical activity will be objectively measured by an accelerometer worn for one week.

At Weeks 4 and 8, participants will be contacted via phone to monitor their depressive symptoms, and self-reported physical activity levels and sedentary behaviour.
Upon program completion (after 12 weeks), participants will complete a follow-up survey about key study outcomes as detailed above, and will again wear an accelerometer for one week.
Control group
Active

Outcomes
Primary outcome [1] 306828 0
Program feasibility of adopting a home-environment physical activity program assessed by questionnaire items adapted from Teychenne, et al (2018).

Teychenne, et al (2018). Feasibility and acceptability of a home-based physical activity program for postnatal women with depressive symptoms: a pilot study. Mental Health and Phys Act, 14:82-89.
Timepoint [1] 306828 0
12 weeks post-intervention commencement.
Primary outcome [2] 307148 0
Appeal of intervention materials, including provision of exercise equipment, logbook, online blog, e-health Web application assessed by questionnaire items adapted from Teychenne, et al (2018).

Teychenne, et al (2018). Feasibility and acceptability of a home-based physical activity program for postnatal women with depressive symptoms: a pilot study. Mental Health and Phys Act, 14:82-89.
Timepoint [2] 307148 0
12 weeks post-intervention commencement.
Secondary outcome [1] 349840 0
Change in Post Natal Depression risk assessed by questionnaire using the Edinburgh postnatal depression scale (Cox, Holden, and Sagovsky, 1987).

Cox, Holden, and Sagovsky (1987). Detection of postnatal depression: development of the 10-item Edinburgh Postnatal Depression scale. Brit J Psychiatry, 150(June):782-786.
Timepoint [1] 349840 0
- Pre-intervention (Time 0)
- Week 4 of 12-week intervention period
- Week 8 of 12-week intervention period
- 12 weeks post-intervention commencement.
Secondary outcome [2] 349841 0
Physical activity objectively measured by accelerometers worn for one week pre- and post-intervention only.
Timepoint [2] 349841 0
- Pre-intervention (Time 0)
- 12 weeks post-intervention commencement.
Secondary outcome [3] 349932 0
Sedentary behaviour objectively measured by accelerometers worn for one week pre- and post-intervention only.
Timepoint [3] 349932 0
- Pre-intervention (Time 0)
- 12 weeks post-intervention commencement.
Secondary outcome [4] 349933 0
Self-efficacy assessed by validated questionnaire items adapted from Marcus and Forsyth, (2003).

Marcus and Forsyth (2003). Motivating people to be physically active. Human Kinetics; Champaign, IL.
Timepoint [4] 349933 0
- Pre-intervention (Time 0)
- 12 weeks post-intervention commencement.
Secondary outcome [5] 350906 0
Physical activity subjectively assessed using Active Australia Survey measures (AIHW, 2003) at four time points as detailed below.

Australian Institute of Health and Welfare (2003). The Active Australia Survey: a guide and manual for implementation, analysis and reporting. Canberra: AIHW.
Timepoint [5] 350906 0
- Pre-intervention (Time 0)
- Week 4 of 12-week intervention period
- Week 8 of 12-week intervention period
- 12 weeks post-intervention commencement.
Secondary outcome [6] 350907 0
Sedentary behaviour subjectively assessed using previously validated questions (Teychenne and Hinkley, 2016) and two items from the International Physical Activity Questionnaire (Craig, et al. 2003) at four time points as detailed below.

Craig et al (2003). International Physical Activity Questionnaire: 12-country reliability and validity. Med Sci Sports Exerc, 35(2003):1381-1395.

Teychenne and Hinkley (2016). Associations between Screen-Based Sedentary Behaviour and Anxiety Symptoms in Mothers with Young Children. PLoS One. 11(5):e0155696.
Timepoint [6] 350907 0
- Pre-intervention (Time 0)
- Week 4 of 12-week intervention period
- Week 8 of 12-week intervention period
- 12 weeks post-intervention commencement.
Secondary outcome [7] 350908 0
Physical activity barriers and facilitators (assessed by validated questionnaire items adapted from Brownson, et al. (2001).

Brownson, et al. (2001). Environmental and policy determinants of physical activity in the United States. Am J Pub Health 91; 1995-2003.
Timepoint [7] 350908 0
- Pre-intervention (Time 0)
- 12 weeks post-intervention commencement.
Secondary outcome [8] 350909 0
Goal setting assessed by validated questionnaire items adapted from Giles-Corti and Donovan (2003).

Giles-Corti and Donovan (2003) Relative influences of individual, social environmental, and physical environmental correlates of walking. Am J Public Health, 93(9):1583-9.
Timepoint [8] 350909 0
- Pre-intervention (Time 0)
- 12 weeks post-intervention commencement.
Secondary outcome [9] 350910 0
Well-being assessed by questionnaire (other than post-natal depression risk, as measured by the Generalised Anxiety Disorder 7-Item Scale; adapted from Spitzer, Kroenke and Williams, 2006).

Spitzer, Kroenke and Williams (2006). A brief measure for assessing Generalized Anxiety Disorder: the GAD-7. Arch Intern Med, 166(10):1092-1097.
Timepoint [9] 350910 0
- Pre-intervention (Time 0)
- 12 weeks post-intervention commencement.
Secondary outcome [10] 350911 0
Sleep assessed by questionnaire items adapted from Saxby et al. (2016).

Saxby, et al (2016). Sleep quality predicts persistence of parental postpartum depressive symptoms and transmission of depressive symptoms from mothers to fathers. Ann Behav Med, 50(6):862–875.
Timepoint [10] 350911 0
- Pre-intervention (Time 0)
- 12 weeks post-intervention commencement.
Secondary outcome [11] 350912 0
Eating behaviours assessed by questionnaire items adapted from ABS, 2013.

Australian Bureau of Statistics (2013). Australian Health Survey: Users' Guide, 2011-13. Canberra: 4363.0.55.001.
Timepoint [11] 350912 0
- Pre-intervention (Time 0)
-12 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if they:
• are 3-9 months postpartum,
• are classified 'at-risk' of PND - i.e. those who score 10 or greater on the Edinburgh postnatal depression scale (Cox, Holden, and Sagovsky, 1987),
• do not currently own a treadmill/stationary bicycle,
• are aged 18 years and older,
• are not meeting the PA guidelines (150 minutes per week of moderate/vigorous physical activity), and
• living in a suburb of Melbourne

Cox, Holden, and Sagovsky (1987). Detection of postnatal depression: development of the 10-item Edinburgh Postnatal Depression scale. Brit J Psychiatry, 150(June):782-786.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals cannot take part if they are:
• women who are currently pregnant (due to the project aiming to determine whether a home-based PA support program is perceived as feasible to increase PA by new mothers who are 3-9 months postpartum with heightened PND symptoms).
• residing in rural regions outside Melbourne (as the equipment hire company does not deliver beyond Melbourne suburbs)
• taking prescribed anti-depressant medication (since this may confound results on the effectiveness of the physical activity program on indicators of mood), and
• non-English speakers (as participants will need to be able to communicate fluently since the study does not have resource capacity to provide project materials in languages other than English).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomization sequence will be stored securely and separately from the participant database and will not be accessible by investigators who are blinded to participant allocation. Only the statistician and project manager will be informed of the allocation and enrolment of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After initial screening (and once consent forms are returned) women will be randomly assigned to either the behavioral intervention (n = 31) or control (n= 31) conditions by using a computer-generated block randomization sequence produced and implemented by a statistician that involves blocks of 2 and 4 in varying combinations. Level of education (Completed tertiary education/Not completed tertiary education) will be applied as a stratification variable during randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculation:
Thirty-one participants will be recruited in each group (total 62). With an expected drop out of 20% (Daley, Macarthur, and Winter, 2007) it is anticipated a final sample of 25 per group for analysis. Based on our previous feasibility work (Teychenne, et al. 2018) recruiting postpartum women for a similar physical activity support program, whereby 11 out of 37 (30%) women screened were eligible (i.e. women were experiencing heightened depressive symptoms and insufficiently active) and participated, it is estimated screening 194 women will be required to obtain 62 eligible participants.

Physical activity:
Prior accelerometry data has shown that the standard deviation (SD) for MVPA (mins/day) is approximately 20 for women of child-bearing age 25 (Troiano, et al. 2008). Based on an increase of 10 mins/day in MVPA and a within-participant correlation of 0.5, we will have 53% power to reject the null hypothesis that the response difference is zero and type 1 error probability of 0.05. Overall this represents a 70 mins/week increase in MVPA, which is a substantial achievement towards meeting the PA guidelines of 150 mins/week. Although the PA guidelines will be the target for women in the program, realistically we might not expect new mothers to reach this so have powered to detect a smaller but still important increase.

Depressive symptoms:
In our pilot study/feasibility data (Teychenne, et al. 2018) we saw a standard deviation (SD) on the EPDS of 2.9 for the same population group (i.e. postnatal women experiencing heightened depressive symptoms and are insufficiently active). Given our anticipated final sample size after drop-out (n=25 per group) and assuming a within-participant correlation of 0.5, we will have 80% power to detect a mean difference of 2 units between treatment and control groups, with type 1 error probability of 0.05.

Statistical analysis:
Stata/SE 15 will be used for quantitative statistical analyses. Paired-samples t-tests (two-tailed) will be used to assess changes in treadmill/stationary bicycle use, physical activity, sedentary behaviour, theoretical constructs of behaviour change, depressive symptoms, and nutrition outcomes between baseline and follow-up. Continuous and categorical variables will be described as mean (sd) and n (%), respectively. Linear mixed models will be employed to utilise as much data as possible and minimise bias, assuming some missing data and dropouts. We have access to a consultant biostatistician who can provide guidance on analyses.

Daley, Macarthur, and Winter (2007), The role of exercise in treating postpartum depression: a review of the literature. J Midwifery Womens Health, 52(1):56-62.

Teychenne, et al (2018). Feasibility and acceptability of a home-based physical activity program for postnatal women with depressive symptoms: a pilot study. Mental Health and Phys Act, 14:82-89.

Troiano, et al (2008). Physical activity in the United States measured by accelerometer. Med Sci Sports Exerc, 40(1):181-8.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300139 0
University
Name [1] 300139 0
Institute for Physical Activity and Nutrition Research (IPAN)
Address [1] 300139 0
School of Exercise and Nutrition Sciences, Deakin University, Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125.
Country [1] 300139 0
Australia
Primary sponsor type
Individual
Name
Dr Megan Teychenne
Address
Institute for Physical Activity and Nutrition Research (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125.
Country
Australia
Secondary sponsor category [1] 299616 0
None
Name [1] 299616 0
Address [1] 299616 0
Country [1] 299616 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300972 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 300972 0
Deakin University, Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Ethics committee country [1] 300972 0
Australia
Date submitted for ethics approval [1] 300972 0
26/04/2018
Approval date [1] 300972 0
14/06/2018
Ethics approval number [1] 300972 0
2018-139

Summary
Brief summary
The Mums on the Move study aims to explore the feasibility of a multi-component 12-week home-environment pilot intervention delivered to first-time mothers at risk of PND for increasing physical activity, with the view to inform the development of a larger intervention trial in future. The study also aims to examine changes in depressive symptoms as a result of participating in the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85470 0
Dr Megan Teychenne
Address 85470 0
Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences. Deakin University. Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Country 85470 0
Australia
Phone 85470 0
+61 3 9244 6910
Fax 85470 0
Email 85470 0
megan.teychenne@deakin.edu.au
Contact person for public queries
Name 85471 0
Dr Megan Teychenne
Address 85471 0
Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences. Deakin University. Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Country 85471 0
Australia
Phone 85471 0
+61 3 9244 6910
Fax 85471 0
Email 85471 0
megan.teychenne@deakin.edu.au
Contact person for scientific queries
Name 85472 0
Dr Megan Teychenne
Address 85472 0
Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences. Deakin University. Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125
Country 85472 0
Australia
Phone 85472 0
+61 3 9244 6910
Fax 85472 0
Email 85472 0
megan.teychenne@deakin.edu.au

No data has been provided for results reporting
Summary results
Not applicable