Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000346774p
Ethics application status
Submitted, not yet approved
Date submitted
9/02/2022
Date registered
25/02/2022
Date last updated
30/03/2022
Date data sharing statement initially provided
25/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Body image and Instagram use in postpartum women
Scientific title
Utilising social networking sites to convey health information to postpartum women: is it acceptable and does it impact on body satisfaction?
Secondary ID [1] 306078 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
State body satisfaction 324728 0
State body appreciation 324729 0
Condition category
Condition code
Mental Health 322276 322276 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single blinded three-arm randomised experimental study. All of the three experimental groups will be exposed to 15 Instagram images of women with a thin-average level of adiposity. However, only two of the groups will also be exposed to images focused on an aspect of postpartum health information, either infrequently (5 images) or more frequently (15 images).

This intervention will be delivered online via REDCap. Participants will scan the study QR code to read the study information sheet, and if willing to participate in the study, will be able to immediately begin completing their questionnaire (implied consent). In total, the questionnaire will take approximately 30-minutes to complete. The first part of the questionnaire will ask participants about key demographic information, as well as details about their social networking site use, whether they access health information on these sites, whether they would like to access health information on these sites, what type of health information they would like included on these sites, and their current exercising and dieting habits. The second part of the questionnaire will investigate how women view their bodies, and how exposure to images captured from Instagram impacts this. This will involve answering questions about their views towards their body before and after viewing images captured from Instagram to determine their body satisfaction and body appreciation.

For the second part of the questionnaire, participants will be randomised (at the time of competition) to one of three experimental conditions, whereby they will be exposed to their allocated set of images as follows: Group 1: 15 Instagram images of women with a thin-average level of adiposity, Group 2: 15 Instagram images of women with a thin-average level of adiposity PLUS 5 images focused on an aspect of postpartum health information, and Group 3: 15 Instagram images of women with a thin-average level of adiposity PLUS 15 images focused on an aspect of postpartum health information.

One of the questions will prompt participants to click on a link that will take them to a video of their allocated group's images. Each image will be displayed for 7 seconds. To ensure attention, participants will be asked to indicate approximately how many of the images were of women and how many included health information, i.e. "none", "about one quarter", "about half", "about three quarters" or "all of them".
Intervention code [1] 322483 0
Treatment: Other
Comparator / control treatment
Group 1: 15 Instagram images of women with a thin-average level of adiposity
Control group
Active

Outcomes
Primary outcome [1] 329949 0
Change in state body satisfaction - Visual Analogue Scales (VAS) will be used to obtain state measures of body dissatisfaction (weight dissatisfaction, appearance dissatisfaction). Participants will be instructed to drag the marker along a line from 0 (none) to 100 (very much) to the appropriate position to indicate how they feel ‘right now’ for each item. Scores on the weight and appearance dissatisfaction items will be averaged to produce an overall body dissatisfaction score ranging from 0 to 100.
Timepoint [1] 329949 0
This outcome will be measured before and after the participants view their allocated set of images, within their 30-minute REDCap questionnaire
Primary outcome [2] 330490 0
Change in state body appreciation - VAS will also be used to obtain state measures of body appreciation. Participants will be asked their current feelings for three items (“Despite my flaws, I accept my body for what it is,” “My feelings towards my body are positive for the most part” and “My self-worth is independent of my body shape or weight”). These items are adapted as state versions of items contained in the Body Appreciation Scale. Scores on the three items will be averaged to produce an index of state body appreciation ranging from 0 to 100.
Timepoint [2] 330490 0
This outcome will also be measured before and after the participants view their allocated set of images, within their 30-minute REDCap questionnaire
Secondary outcome [1] 404386 0
Nil
Timepoint [1] 404386 0
Nil

Eligibility
Key inclusion criteria
1. Australian-residing women
2. Given birth within the last 2 years
3. Aged 18-years and older
4. Access to a phone or computer with internet access

Minimum age
18 Years
Maximum age
44 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Low English proficiency
2. Women who cannot provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consenting participants will be randomised at the time of completion to one of three experimental conditions, whereby they will be exposed to their allocated set of images as part of the completion of their allocated survey.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be used for this study. The first 100 participants will be allocated to group 1, the second 100 to group 2 and the final 100 to group 3. Study investigators will regularly check participant numbers in REDCap to ensure that once 100 participants have been allocated to group 1, the next 100 participants are allocated to group 2, and the last 100 are allocated to group 3.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For this study, we are aiming to recruit a minimum of 300 participants (100 in each experimental condition). This sample size is based on a previous similar study (Tiggemann et al. 2020), where they recruited 100 participants to each experimental condition.

Planned statistical analyses includes descriptive statistics, ANOVA to compare changes in state body satisfaction and state body appreciation between experimental conditions and t-tests to detect changes in state body satisfaction and state body appreciation before and after exposure to experimental condition.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2022
Actual
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310413 0
Other Collaborative groups
Name [1] 310413 0
Women’s Health Research Translation Network
Country [1] 310413 0
Australia
Primary sponsor type
Individual
Name
Dr Megan Gow
Address
Institute of endocrinology and diabetes, The Children’s Hospital at Westmead, Westmead, NSW, 2145
Country
Australia
Secondary sponsor category [1] 311570 0
Individual
Name [1] 311570 0
Ms Maddison Thomas
Address [1] 311570 0
Institute of endocrinology and diabetes, The Children’s Hospital at Westmead, Westmead, NSW, 2145
Country [1] 311570 0
Australia
Secondary sponsor category [2] 311643 0
Individual
Name [2] 311643 0
Dr Heike Roth
Address [2] 311643 0
Centre for Midwifery, Child and Family Health, University of Technology Sydney, CB.10.11.111, 235 Jones Street, Ultimo, NSW, 2007
Country [2] 311643 0
Australia
Secondary sponsor category [3] 311644 0
Individual
Name [3] 311644 0
A/Prof Amanda Henry
Address [3] 311644 0
Women's and Children's Health, Level 2, Prichard Wing, St George Hospital, Gray St Kogarah, NSW, 2217
Country [3] 311644 0
Australia
Secondary sponsor category [4] 311645 0
Individual
Name [4] 311645 0
Dr Lynne Roberts
Address [4] 311645 0
1 South Maternity, St George Public Hospital, Gray Street, Kogarah, NSW, 2217
Country [4] 311645 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310060 0
The University of Sydney’s Human Research Ethics Committee.
Ethics committee address [1] 310060 0
Ethics committee country [1] 310060 0
Australia
Date submitted for ethics approval [1] 310060 0
14/02/2022
Approval date [1] 310060 0
Ethics approval number [1] 310060 0

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

Contacts
Principal investigator
Name 116350 0
Dr Megan Gow
Address 116350 0
Institute of endocrinology & diabetes, The Children’s Hospital at Westmead, Westmead, NSW, 2145
Country 116350 0
Australia
Phone 116350 0
+61421078958
Fax 116350 0
Email 116350 0
[email protected]
Contact person for public queries
Name 116351 0
Megan Gow
Address 116351 0
Institute of endocrinology & diabetes, The Children’s Hospital at Westmead, Westmead, NSW, 2145
Country 116351 0
Australia
Phone 116351 0
+61421078958
Fax 116351 0
Email 116351 0
[email protected]
Contact person for scientific queries
Name 116352 0
Megan Gow
Address 116352 0
Institute of endocrinology & diabetes, The Children’s Hospital at Westmead, Westmead, NSW, 2145
Country 116352 0
Australia
Phone 116352 0
+61421078958
Fax 116352 0
Email 116352 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14517Informed consent form    Individuals interested in participating in this st... [More Details]
14518Clinical study report    At completion of the questionnaire, participants w... [More Details]



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.