Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001190594
Ethics application status
Approved
Date submitted
5/09/2024
Date registered
30/09/2024
Date last updated
30/09/2024
Date data sharing statement initially provided
30/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Body Project in New Zealand
Scientific title
Evaluation of the impact of the Body Project on dieting behaviours and dietary intake, and experience of participation in New Zealand university students, peer educators and counsellors.
Secondary ID [1] 312898 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
body dissatisfaction 335053 0
Condition category
Condition code
Mental Health 331563 331563 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Body Project (developed by Eric Stice, Paul Rohde & Heather Shaw) delivered in synchronous group format online over 4 consecutive weeks by peer educators. Peer educators are Massey University Health Science students who have undergone Body Project training with Massey University Health & Counselling counselors who have themselves undergone Body Project training with Eric Stice.

The Body Project is a programme that has been designed to prevent eating disorder development by targeting young females with known risk factors, such as body dissatisfaction. It specifically aims to reduce thin idealisation by challenging them to reduce the pursuit for this unrealistic ideal.

The Body Project is run over 4 weeks in weekly 1-hour online sessions. Session 1 topics are introduction, voluntary commitment and overview, definition and origin of the thin ideal, costs associated with the thin ideal and homework. Session 2 topics are reinforcing voluntary commitment, letter to adolescent girl exercise debriefing, mirror exercise debriefing, role plays to discourage the pursuit of thin ideal and homework. Session 3 topics are reinforcing voluntary commitment, community interview debriefing, role play on disrupting thin ideal statements, reasons for signing up, behavioural challenge, top 10 list debriefing and homework. Session 4 topics are reinforcing voluntary commitment, behavioural challenge debriefing, body activism debriefing, letter to a younger self debriefing, discussion of benefits of group and closure, self-affirmation exercise, homework and closure. Participants complete a consent form and questionnaire including the outcome measures prior to the first session. Following the intervention, they are requested to complete the questionnaire again and invited to participate in a 30-minute semi-structured depth interview with a member of the research team. Interviews will be audio recorded. All intervention sessions are video/audio recorded to enable fidelity rating and attendance check. For inclusion in the evaluation, participants are required to attend at least one of the weekly online sessions. Participants are provided with weekly homework estimated to take up to 30 minutes to complete, but inclusion in the evaluation won't be dependent on homework completion.
Intervention code [1] 329433 0
Prevention
Comparator / control treatment
Provided with a link via email to a 1-hour eating disorder documentary video "Dying to be Thin" . Adherence to the control treatment (i.e., whether they watched the documentary will be monitored by seeing how times the video was viewed using the Mediasite video platform analytics.
Control group
Active

Outcomes
Primary outcome [1] 339297 0
Dieting behaviours
Timepoint [1] 339297 0
Baseline and immediately following completion of the fourth intervention session
Primary outcome [2] 339298 0
Body dissatisfaction
Timepoint [2] 339298 0
Baseline and immediately following completion of the fourth intervention session
Primary outcome [3] 339299 0
Student experiences
Timepoint [3] 339299 0
Invitations immediately following completion of the fourth intervention session. Interviews to be completed within 4 weeks of the invitation.
Secondary outcome [1] 439390 0
Healthcare utilisation
Timepoint [1] 439390 0
Baseline and immediately following completion of the fourth intervention session
Secondary outcome [2] 439391 0
Thin-ideal internalisation
Timepoint [2] 439391 0
Baseline and immediately following completion of the fourth intervention session
Secondary outcome [3] 439393 0
Negative affect
Timepoint [3] 439393 0
Baseline and immediately following completion of the fourth intervention session
Secondary outcome [4] 439394 0
Psychosocial functioning
Timepoint [4] 439394 0
Baseline and immediately following completion of the fourth intervention session
Secondary outcome [5] 439395 0
Wellbeing
Timepoint [5] 439395 0
Baseline and following intervention/control
Secondary outcome [6] 439417 0
Dietary intake
Timepoint [6] 439417 0
Baseline and immediately following completion of the fourth intervention session
Secondary outcome [7] 439756 0
Peer-educator experiences - this is a primary outcome.
Timepoint [7] 439756 0
Invitations immediately following completion of the fourth intervention session. Interviews to be completed within 4 weeks of the invitation.
Secondary outcome [8] 439757 0
Counsellor experiences - this is a primary outcome
Timepoint [8] 439757 0
Invitations immediately following completion of the fourth intervention session. Interviews to be completed within 4 weeks of the invitation.

Eligibility
Key inclusion criteria
Participants will be individuals identifying as female aged 18-30 years old enrolled at Massey University with self-reported body image concerns. Peer educators will be individuals identifying as female aged 18-35 enrolled at Massey University who have completed Body Project training. Counsellor trainers will be employed at Massey University Student Health and Counselling and completed Body Project training.
Minimum age
18 Years
Maximum age
30 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those undergoing treatment for a diagnosed eating disorder.

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)
1. Participants self report meeting inclusion criteria during sign up (identify as female, 18-30yrs, Massey student, never diagnosed with ED)
2. Participants assigned an ID number (BP001, etc) based on order of recruitment.
3. ID numbers put into randomisation website
4. Even randomised numbers allocated to 1 session group, odd numbers allocated to 4 session group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation completed using an online list randomiser and allocating odd/even numbers to intervention/control.
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
Actual
9/09/2024
Date of last participant enrolment
Anticipated
3/04/2026
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
80
Accrual to date
7
Final
Recruitment outside Australia
Country [1] 26544 0
New Zealand
State/province [1] 26544 0

Funding & Sponsors
Funding source category [1] 317332 0
University
Name [1] 317332 0
Massey University Postgraduate Research Support Fund
Country [1] 317332 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Country
New Zealand
Secondary sponsor category [1] 319617 0
None
Name [1] 319617 0
Address [1] 319617 0
Country [1] 319617 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316064 0
Massey University Human Ethics Committee: Ohu Matatika 2 (formerly Northern Committee)
Ethics committee address [1] 316064 0
Ethics committee country [1] 316064 0
New Zealand
Date submitted for ethics approval [1] 316064 0
26/04/2024
Approval date [1] 316064 0
20/06/2024
Ethics approval number [1] 316064 0
Human Ethics Application OM1 24/11

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

Contacts
Principal investigator
Name 136658 0
Prof Ajmol Ali
Address 136658 0
Massey University - Albany College of Sport, Exercise and Nutrition, SNW Extension Building Private Bag 102 904 North Shore Auckland 0745
Country 136658 0
New Zealand
Phone 136658 0
+64 09 213 6414
Fax 136658 0
Email 136658 0
[email protected]
Contact person for public queries
Name 136659 0
Ajmol Ali
Address 136659 0
Massey University - Albany College of Sport, Exercise and Nutrition, SNW Extension Building Private Bag 102 904 North Shore Auckland 0745
Country 136659 0
New Zealand
Phone 136659 0
+64 09 213 6414
Fax 136659 0
Email 136659 0
[email protected]
Contact person for scientific queries
Name 136660 0
Ajmol Ali
Address 136660 0
Massey University - Albany College of Sport, Exercise and Nutrition, SNW Extension Building Private Bag 102 904 North Shore Auckland 0745
Country 136660 0
New Zealand
Phone 136660 0
+64 09 213 6414
Fax 136660 0
Email 136660 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?

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.