Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001079730
Ethics application status
Approved
Date submitted
25/07/2022
Date registered
4/08/2022
Date last updated
20/06/2024
Date data sharing statement initially provided
4/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Food, Move, Sleep (FOMOS) for Postnatal Mental Health
Scientific title
The efficacy of the Food, Move, Sleep (FOMOS) for Postnatal Mental Health program for improving postnatal depressive symptoms: A randomised controlled trial.
Secondary ID [1] 307289 0
None
Universal Trial Number (UTN)
Trial acronym
FOMOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postnatal depression (PND) 326575 0
Condition category
Condition code
Mental Health 323819 323819 0 0
Depression
Reproductive Health and Childbirth 324308 324308 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
FOMOS is an evidence-based, multi-component, home-based health behaviour program, which involves provision of home exercise equipment (free hire), information/motivational material (e.g. goal setting and self-monitoring) and social support delivered via e-health (website and text messaging) and a popular social media platform (e.g., Instagram).
For the first 3-months, women will receive:
- Home-exercise equipment: Free-hire (e.g. exercise bike/treadmill/cross-trainer/yoga bands and/or resistance bands per preference) to overcome barriers of leaving home and enhance initial engagement.

For the first 6-months, women will receive:
- Website: Access to a purposely built website, targeting knowledge (diet quality, physical activity, sleep), self-efficacy, overcoming barriers, goal-setting and self-monitoring. The website includes written informative and educational materials, short videos, as well as links to other resources (e.g., Government or not-for-profit health information websites).
- Social media: Access to a private Instagram page providing “bite-sized” information related to website content.
- Text messaging: One- and two-way support, educational, and encouraging text messages delivered approximately twice weekly. The aim of these text messages is to enhance social-support, goal-setting, monitoring, and feedback, as well as to encourage participants to engage with different components of the website and Instagram.


*No recommendation or limitation regarding timing or usage of website, social media and text messages will be given to participants, and they can read the materials and engage with the website in a time-frame suitable and convenient to them.
*The FOMOS Instagram account will post approximately 6 - 10 posts per week (and each post will take approximately 2-3 minutes to read/watch). Participants will be encouraged to comment, like, and interact with posts.
*Text messages will be one or two sentences, max of one minute to read each message.
*Engagement with the different components of the website (e.g., the number of pages visited) and website login data (e.g., the number of unique website visitors per month and frequency of views of the videos) will be systematically tracked and recorded throughout the entire intervention and follow-up period by Wix web Analytics. Engagement with the text messages and social media will be measured by study specific self-reported questionnaire.
Intervention code [1] 323733 0
Behaviour
Intervention code [2] 323734 0
Lifestyle
Comparator / control treatment
Control group:
During the intervention period, the wait-list control group will not receive any intervention from the research team, and as such will undergo usual care in that period. Given that participants will not necessarily be a clinical population (i.e. they are screened for heightened depressive symptoms but it is likely very few will be clinically depressed), this usual care may range from having no additional treatments/supports to undertaking psychotherapy or anti-depressant medication (note - changes in these treatments will be captured in self-report surveys).
Control group
Active

Outcomes
Primary outcome [1] 331609 0
Mean group difference in EPDS total score immediately post-program (6 months post-baseline) assessed by questionnaire using the Edinburgh Postnatal Depression Scale (EPDS) (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] 331609 0
- Pre-intervention (Baseline)
- 6 months post-intervention commencement
Secondary outcome [1] 411067 0
Sustained intervention effects on postnatal depressive symptoms assessed by questionnaire using the Edinburgh Postnatal Depression Scale (EPDS) (Cox, Holden, and Sagovsky, 1987) between baseline and 18 months post-intervention commencement.

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] 411067 0
- Pre-intervention (Baseline)
- 12 months post-intervention commencement
Secondary outcome [2] 411069 0
Physical activity assessed using wrist-worn ActiGraph GT9X Link (device-measured) (Sasaki, John & Freedson 2011; Troiano et al. 2014)

Sasaki, JE, John, D & Freedson, PS 2011, 'Validation and comparison of ActiGraph activity monitors', Journal of Science and Medicine in Sport, vol. 14, no. 5, pp. 411-6.
Troiano, RP, McClain, JJ, Brychta, RJ & Chen, KY 2014, 'Evolution of accelerometer methods for physical activity research', British Journal of Sports Medicine, vol. 48, no. 13, p. 1019.
Timepoint [2] 411069 0
- Pre-intervention (Baseline)
- 6 months post-intervention commencement
- 12 months post-intervention commencement
Secondary outcome [3] 411070 0
Sedentary time assessed using ActiGraph GT9X Link
Timepoint [3] 411070 0
- Pre-intervention (Baseline)
- 6 months post-intervention commencement
- 12 months post-intervention commencement

Secondary outcome [4] 411071 0
Sleep quality assessed using sleep quality (PSQI) questionnaire (Saxbe et al. 2016)

Saxbe, DE, Schetter, CD, Guardino, CM, Ramey, SL, Shalowitz, MU, Thorp, J, Vance, M, Eunice Kennedy Shriver National Institute for Child, H & Human Development Community Child Health, N 2016, 'Sleep Quality Predicts Persistence of Parental Postpartum Depressive Symptoms and Transmission of Depressive Symptoms from Mothers to Fathers', Annals of Behavioral Medicine, vol. 50, no. 6, pp. 862-75.
Timepoint [4] 411071 0
- Pre-intervention (Baseline)
- 6 months post-intervention commencement
- 12 months post-intervention commencement
Secondary outcome [5] 412502 0
Vegetable consumption assessed using a modified version of the Australian Short Dietary Screener (Aus_SDS) (Gadowski et al. 2020)

Gadowski AM, McCaffrey TA, Heritier S, Curtis AJ, Nanayakkara N, Zoungas S, et al. Development, relative validity and reproducibility of the Aus-SDS (Australian short dietary screener) in adults aged 70 years and above. Nutrients. 2020;12(5):1436
Timepoint [5] 412502 0
- Pre-intervention (Baseline)
- 6 months post-intervention commencement
- 12 months post-intervention commencement
Secondary outcome [6] 412503 0
Fruit consumption assessed using a modified version of the Australian Short Dietary Screener (Aus_SDS) (Gadowski et al. 2020)

Gadowski AM, McCaffrey TA, Heritier S, Curtis AJ, Nanayakkara N, Zoungas S, et al. Development, relative validity and reproducibility of the Aus-SDS (Australian short dietary screener) in adults aged 70 years and above. Nutrients. 2020;12(5):1436
Timepoint [6] 412503 0
- Pre-intervention (Baseline)
- 6 months post-intervention commencement
- 12 months post-intervention commencement

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if they:
• Are mothers 2-12 months postpartum;
• Living in selected metropolitan, rural, regional areas in VIC, NSW, SA. Remote areas are excluded as the equipment hire companies utilised for the purpose of this study may not deliver to remote areas;
• Experiencing heightened PND symptoms (score 10 or greater than 10 on Edinburgh PND Scale);
• Are insufficiently active (<150 mins/week of moderate physical activity or 75 mins of vigorous physical activity per week – or equivalent combination);
• Not meeting dietary guidelines (not consuming the recommended serves per day for fruit and vegetables);
• Not meeting sleep guidelines (shorter than recommended sleep (less than 7hrs) and/or poor quality sleep (“Fairly Bad” or “Very Bad” sleep)) assessed using two items from the PSQI;
• Are able to communicate fluently in English;
• Have or are willing to create an Instagram account for use during the intervention period.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Living with an injury/illness/disability that prevents physical activity;
• Are pregnant;
• Are children and/or young people (i.e. <18 years);
• Have a diagnosed eating disorder, complex dietary requirements, or any socio-cultural, religious, or medical reasons which preclude their ability to follow general dietary advice or participate in a lifestyle intervention.

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)
Central Randomisation by computer (Redcap program)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Participants will be randomised (1:1) to either the FOMOS program (intervention group)(n=110) or to wait-list control group (n=110) stratified by 1) site (VIC, NSW, SA); 2) and baby age (i.e., equal to 6 months and older than 6 months).
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
For quantitative data, Stata/SE 13.1 will be used for statistical analyses. All statistical analysis will be conducted on an intention-to-treat basis. Baseline characteristics will be described and compared between groups using summary measures and tests selected based on variable distribution. The effect of the intervention on each of the outcomes will be assessed using linear mixed models including study arm, time, time by group interaction and the stratification factors (state of residence, anti-depressant use, and baby age group) as fixed effects and participant as a random effect.
Missing data Effective data collection at scheduled times will be monitored and attrition will be minimized using the strategies described in “Recruitment and Retention”. Reasons for dropout will be collected for all participants withdrawing from the study. Complete case analysis will be used for outcomes where missing completely at random is a plausible assumption; or multiple imputation for outcomes where missing at random is a plausible mechanism. We will have access to experienced consultant biostatistician who will be working with the data.
For qualitative data, after transcribing audio-recordings, Nvivo software will be used to facilitate thematic analyses regarding degrees of engagement with core components (e.g., exercise equipment, website use, SMS) and factors influencing implementation outcomes and program appeal (e.g., adoption, acceptability, appropriateness, costs, feasibility, penetration and sustainability).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2022
Actual
7/08/2023
Date of last participant enrolment
Anticipated
1/11/2024
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
220
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC

Funding & Sponsors
Funding source category [1] 311572 0
Government body
Name [1] 311572 0
NHMRC
Country [1] 311572 0
Australia
Primary sponsor type
Individual
Name
Associate Prof Megan Teychenne
Address
Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, Melbourne, Vic 3125, Australia
Country
Australia
Secondary sponsor category [1] 313027 0
None
Name [1] 313027 0
Address [1] 313027 0
Country [1] 313027 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311020 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 311020 0
Ethics committee country [1] 311020 0
Australia
Date submitted for ethics approval [1] 311020 0
27/06/2022
Approval date [1] 311020 0
30/08/2022
Ethics approval number [1] 311020 0
2022-188

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119722 0
A/Prof Megan Teychenne
Address 119722 0
Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, Melbourne, Vic 3125, Australia
Country 119722 0
Australia
Phone 119722 0
+61392446910
Fax 119722 0
Email 119722 0
[email protected]
Contact person for public queries
Name 119723 0
Megan Teychenne
Address 119723 0
Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, Melbourne, Vic 3125, Australia
Country 119723 0
Australia
Phone 119723 0
+61392446910
Fax 119723 0
Email 119723 0
[email protected]
Contact person for scientific queries
Name 119724 0
Megan Teychenne
Address 119724 0
Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, Melbourne, Vic 3125, Australia
Country 119724 0
Australia
Phone 119724 0
+61392446910
Fax 119724 0
Email 119724 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
Individual data will not be shared. Only the chief investigator, project manager and other members of the research team will have access to all the data. This is stored in a secure password-protected server at Deakin University. All data presented in published papers and conferences will be completely anonymous and de-identified to ensure that participant confidentiality is maintained.


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
SourceTitleYear of PublicationDOI
EmbaseEvaluating a multi-behavioural home-based intervention for reducing depressive symptoms in postnatal women : The food, move, sleep (FOMOS) for postnatal mental health randomised controlled trial protocol.2024https://dx.doi.org/10.1016/j.cct.2023.107383
N.B. These documents automatically identified may not have been verified by the study sponsor.