Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000729820
Ethics application status
Approved
Date submitted
9/04/2021
Date registered
10/06/2021
Date last updated
29/10/2021
Date data sharing statement initially provided
10/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Do They Like My Post? A Three Arm Randomised Control Trial Investigating the Effect of Exposure to Body Positivity (Self-Love) Compared to Fitspiration Social Media Content on Female Adults’ Perceived Body Image.
Scientific title
Do They Like My Post? A Three Arm Randomised Control Trial Investigating the Effect of Exposure to Body Positivity (Self-Love) Compared to Fitspiration Social Media Content on Female Adults’ Perceived Body Image.
Secondary ID [1] 303834 0
None.
Universal Trial Number (UTN)
Trial acronym
none.
Linked study record
None.

Health condition
Health condition(s) or problem(s) studied:
Body image dissatisfaction 321359 0
Disordered eating 321360 0
Condition category
Condition code
Mental Health 319141 319141 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prior to the intervention, the participants will complete the pre-intervention questionnaire, assessing body comparison, thin internalisation, self-esteem, disordered eating symptoms, social media activity, photo investment and photo modification. The pre-intervention questionnaire will occur two weeks prior to the intervention as part of a screening assessment. The pre-intervention questionnaire takes approximately 15 to 20 -minutes. The intervention will occur at the University of Auckland (assigned Grafton or city room), where the researchers will greet the participants and briefly outline the intervention, addressing any questions or concerns the participants may have. The researchers are the primary investigator (a Clinical Health Psychologist and senior lecturer) and the student investigator (a Master of Health Psychology candidate). The researchers will randomise participants using an online 3 digit number generator, which will randomly allocate the numbers to one of three conditions (the fitspiration, self-love, or home and living condition). The researchers will measure all participants screen time (an objective measure of social media use) through participants accessing their screen time through logging in to their personal phone settings. The participants will then be given the baseline questionnaire (on an Ipad) or Qualtrics link (if over Zoom), assessing state self-esteem, state mood and body dissatisfaction. The baseline questionnaire will take 8 minutes to complete. Following the completion of the questionnaire, participants will then complete the social media feed.

Participants in the fitspo condition will view a fitspo social media feed on Instagram using an iPad (or via screen share on Zoom). They will view the feed for 15-minutes by scrolling, reading and watching content. The 15-minutes will be timed using a stopwatch. The content viewed will consist of a range of fitspo quotes (i.e., on diet, exercise, reaching goals), workout images and videos of fitness models and celebrities, as well as women portraying 'fit' body ideals. Following the feed, the researchers will supply a document for the (timed) 5-minute writing task. The task will encourage participants to freely and truly express how they feel about their body right now. Following the task, the participants will then complete the second questionnaire (follow up questionnaire) on state mood, state self-esteem and body dissatisfaction (via a Qualtrics link), which will take 8 minutes.


Participants in the self-love condition will view a self-love/ body positivity social media feed on Instagram using an iPad (or through screen share on Zoom). They will view the feed for 15-minutes by scrolling, reading and watching content. The 15-minutes will be timed using a stopwatch. The content viewed will consist of a range of self-love, self-compassion, self-care, body positivity quotes, body diversity, photos and videos. Following the feed, the researchers will supply a document for the (timed) 5-minute writing task. The task will encourage participants to freely and truly express how they feel about their body right now. Following the task, the participants will then complete the second questionnaire (follow up questionnaire) on state mood, state self-esteem and body dissatisfaction (via a Qualtrics link). Overall, the intervention is anticipated to take 40-minutes to complete. The pre-intervention questionnaire and the intervention (baseline and follow up survey, writing task, screen time measure, introduction and debrief) are anticipated to take 60 minutes.


Intervention code [1] 320138 0
Prevention
Comparator / control treatment
Active control: 'Home living' condition
Participants will view a home living based social media feed on Instagram using an iPad (or via screen share on Zoom). They will view the feed for 15-minutes by scrolling, reading and watching content. The 15-minutes will be timed using a stopwatch. The content viewed will consist of a range of images surrounding gardening, gardening tools, life hacks, garden insects, domestic animals, fruits and vegetables, and garden styling. Following the feed, the researchers will supply a document for the (timed) 5-minute writing task. The task will encourage participants to freely and truly express how they feel about their body right now. Following the task, the participants will then complete the second questionnaire (follow up questionnaire) on state mood, state self-esteem and body dissatisfaction (via a Qualtrics link). The completion of the baseline questionnaire, exposure condition, writing task, follow up questionnaire, introduction and debrief is anticipated to take 40-minutes.
Control group
Active

Outcomes
Primary outcome [1] 327027 0
Body dissatisfaction

Body dissatisfaction will be measured using the Eating Disorder Examination Questionnaire 6.0 (Fairburn & Beglin, 1994; Fairburn & Beglin, 2008). Two items (items 25 and 26) will be used to measure body dissatisfaction. The two items include: “how satisfied are you with your weight?” and “how dissatisfied are you with your shape?” The two items are measured on a 7-point (0-6) forced-choice scale.
Timepoint [1] 327027 0
Pre-intervention, Baseline (questionnaire before exposure to the condition) and post-intervention (questionnaire after exposure to the condition).
The pre-intervention time point will be conducted as part of a screening assessment 2 weeks prior to the baseline assessment. The baseline questionnaire and follow up/post-intervention questionnaire will occur during the intervention, approximately two weeks after the pre-intervention questionnaire.
Primary outcome [2] 327029 0
State self-esteem

The State Self-Esteem Scale (Heatheron & Policy, 1991) is a 20-item measure used to measure state self-esteem. It includes three subscales: appearance, social and performance self-esteem. Items in the appearance subscale include items such as "I feel satisfied with the way my body looks right now", and "I feel self-conscious". Items are scored on a 5-point Likert scale ranging from 1 (not at all) to 5 (extremely). Higher scores reflect greater state self-esteem.
Timepoint [2] 327029 0
Baseline (questionnaire before exposure to the condition) and post-intervention (questionnaire after exposure to the condition).
Secondary outcome [1] 395334 0
Mood

Mood will be assessed through the Profile of Moods questionnaire (McNair et al., 1971). The scale is sensitive enough to measure small changes in mood. The original scale consists of 65-items with six mood subscales (Tension. Anger, Fatigue, Depression, Vigor and Confusion). However, the current study will utilise a 40 -item questionnaire that has been modified by Grove and Prapavessis (1992). The questionnaire asks respondents to circle the number (0-4) that best describes how they feel right now. It has five response options that are anchored as “not at all, a little, moderately, quite a lot, and extremely”. The researchers will calculate a total mood disturbance score by summing the totals for the negative subscales (tension, depression, fatigue, confusion, anger) and subtracting it from the positive subscales (vigour, esteem-related affect).
Timepoint [1] 395334 0
Baseline (questionnaire before exposure to the condition) and post-intervention (questionnaire after exposure to the condition).

Eligibility
Key inclusion criteria
Females eligible to participate in the study need to meet the following criteria: (1) are 18 years of age and above, (2) have access to and use an iPhone or Android phone with a 'screen time' application enabled for at least one week prior to the study intervention, and (3) willing to share their ‘screen time usage’ with the researchers.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they: (1) are unable to read and write English; (2) male; (3) do not have a phone that is able to run the screen time application; (4) unable to attend the intervention through zoom or face-to-face at the FMHS or the University of Auckland city campus.

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)
Online 3-digit number generator through the use of centralised online randomisation via a 3-digit number generator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The 3-digit numbers will be randomly generated with each number being randomly corresponded to a condition (one of three).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/06/2021
Actual
15/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
78
Accrual to date
49
Final
Recruitment outside Australia
Country [1] 23573 0
New Zealand
State/province [1] 23573 0
Auckland

Funding & Sponsors
Funding source category [1] 308229 0
University
Name [1] 308229 0
University of Auckland, Medical and Health Sciences
Country [1] 308229 0
New Zealand
Primary sponsor type
University
Name
University of Auckland, Medical and Health Sciences
Address
The University of Auckland, Medical and Health Sciences
85 Park road
Grafton, Auckland, 1023
Auckland
Private Bag 92019
Country
New Zealand
Secondary sponsor category [1] 309045 0
None
Name [1] 309045 0
Address [1] 309045 0
Country [1] 309045 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308211 0
UNIVERSITY OF AUCKLAND HUMAN PARTICIPANTS ETHICS COMMITTEE (UAHPEC)
Ethics committee address [1] 308211 0
Ethics committee country [1] 308211 0
New Zealand
Date submitted for ethics approval [1] 308211 0
25/01/2021
Approval date [1] 308211 0
26/02/2021
Ethics approval number [1] 308211 0
UAHPEC3279

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

Contacts
Principal investigator
Name 109946 0
Dr Liesje Donkin
Address 109946 0
M&HS Building 507
Level 3, Room 3035
28 Park Avenue
Grafton, Auckland, 1023
Auckland
New Zealand
Country 109946 0
New Zealand
Phone 109946 0
+64 09 923 4175
Fax 109946 0
Email 109946 0
[email protected]
Contact person for public queries
Name 109947 0
Liesje Donkin
Address 109947 0
M&HS Building 507
Level 3, Room 3035
28 Park Avenue
Grafton, Auckland, 1023
Auckland
New Zealand
Country 109947 0
New Zealand
Phone 109947 0
+64 09 923 4175
Fax 109947 0
Email 109947 0
[email protected]
Contact person for scientific queries
Name 109948 0
Liesje Donkin
Address 109948 0
M&HS Building 507
Level 3, Room 3035
28 Park Avenue
Grafton, Auckland, 1023
Auckland
New Zealand
Country 109948 0
New Zealand
Phone 109948 0
+64 09 923 4175
Fax 109948 0
Email 109948 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?




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.