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Trial registered on ANZCTR


Registration number
ACTRN12617000236392
Ethics application status
Approved
Date submitted
9/02/2017
Date registered
15/02/2017
Date last updated
14/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Achieving Body Confidence for Young Children (ABC-4-YC): Helping teachers promote a positive body image for 5- to 8-year-old children.
Scientific title
Evaluating the ‘Achieving Body Confidence for Young Children’ (ABC-4-YC) program compared with delayed intervention to improve child weight bias, appearance-based teasing and body satisfaction in 5- to 8-year-old children.
Secondary ID [1] 291010 0
Nil known
Universal Trial Number (UTN)
U1111-1192-0332
Trial acronym
ABC-4-YC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children's body image 301783 0
Children's weight stigma 301784 0
Children's appearance-based teasing 301785 0
Children's self-esteem 301786 0
Condition category
Condition code
Mental Health 301472 301472 0 0
Eating disorders
Mental Health 301501 301501 0 0
Other mental health disorders
Public Health 301676 301676 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The evaluation of the ABC-4-YC program will be conducted as a cluster randomised controlled trial (RCT), whereby participating classes from each participating school will be randomly allocated to either receive the intervention or delayed intervention.

Arm 1: ABC-4-YC intervention
Children in intervention classes will receive the ABC-4-YC program at school as part of their classroom curriculum via 3 x 1 hour lessons during school hours, delivered over three consecutive days by their regular classroom teacher. Each ABC-4-YC lesson entails reading the children’s storybook Your Body Is Brilliant: Body Respect for children, which aims to teach children about appreciated diversity in body shapes and sizes and respecting and appreciating their own body’s functions. This is followed by class discussions and an individual worksheet activity that aim to help children appreciate differences in their body, celebrate their unique qualities, and appreciate the functionality of their body. One lesson also involves a dance and move activity whereby children listen to a body positive song, and a short video summarising the key messages of the program lessons.
Teachers in the intervention condition will receive a 2-hour face-to-face professional development workshop and teacher handbook and a children's story book to guide the delivery of the ABC-4-YC program in their classroom. The teacher workshop will be delivered by the Chief Investigator who has a PhD in the area of psychology, and is the first author of the ABC-4-YC program materials.

Arm 2: Delayed intervention
Children in the control condition will only be asked to complete interviews. Teachers in the control condition will receive a brief online video informing them about the research and will only be asked to complete questionnaires.

All child participants will complete interviews and teacher participants will complete questionnaires at baseline, post-test, and 6 week follow-up. Parents of children will complete one questionnaire at baseline.

To measure fidelity, a member of the research team will attend at least one lesson from each intervention teacher participant and complete an observation checklist to assess completion of activities, fidelity to the teacher handbook guidelines, and student participation. Intervention teachers will also complete a feedback questionnaire at post-test to assess the degree of completion of program activities and response from their students.
Intervention code [1] 296976 0
Prevention
Comparator / control treatment
Teachers in the delayed intervention group (control condition) will receive a brief online video informing them about the research and then receive the ABC-4-YC teacher workshop online at the completion of their participation. Children in the control condition will receive their regular classroom curriculum during the intervention period, and then the classroom teacher will be able to deliver the program to their class at the completion of their participation. Teachers in the control condition will receive their ABC-4-YC training workshop within 12 weeks after the last data is collected from all participants at their school, and they will be able to deliver the program to their students following that.
Control group
Active

Outcomes
Primary outcome [1] 300893 0
Children's mean Body Esteem Scale score, as measured by the Body Esteem Scale for Children.
Timepoint [1] 300893 0
Baseline, post-test (two weeks after baseline), and 6 week follow-up (6 weeks after post-test assessment).
Primary outcome [2] 300894 0
Children's weight bias, assessed by the Children's Body Attitudes Scale that measures positive and negative weight bias, and an adjective body size scale that measures attribution of characteristics to large and thin body sizes.
Timepoint [2] 300894 0
Baseline, post-test (two weeks after baseline), and 6 week follow-up (6 weeks after post-test assessment).
Primary outcome [3] 300895 0
Frequency of children's appearance-based teasing, as measured by an age-adapted version of the Perception of Teasing Scale and Teasing About My Body subscale from the Child-Adolescent Teasing Scale.
Timepoint [3] 300895 0
Baseline, post-test (two weeks after baseline), and 6 week follow-up (6 weeks after post-test assessment).
Secondary outcome [1] 331141 0
Children's mean self-worth, as measured by an age-adapted version of the Global Self-worth Scale from the Self-perception Assessment.
Timepoint [1] 331141 0
Baseline, post-test (two weeks after baseline), and 6 week follow-up (6 weeks after post-test assessment).
Secondary outcome [2] 331142 0
Children's internalisation of media thin ideals, as measured by an age-adapted version of the Sociocultural Attitudes Towards Appearance Questionnaire.
Timepoint [2] 331142 0
Baseline, post-test (two weeks after baseline), and 6 week follow-up (6 weeks after post-test assessment).

Eligibility
Key inclusion criteria
All participants will live in Melbourne, Australia.
Child participants will be 5- to 8-year-old students from participating Foundation to Year 2 classes.
Teacher participants will be recruited from participating schools, must teach either Foundation, Year 1 or Year 2 (or a composite 1-2 class) and be over the age of 18 years.
Parent participants will be over the age of 18 years, have a good understanding of written and spoken English, and have a child in a participating class.
Minimum age
5 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they live outside of Melbourne, Australia. Child participants will be excluded if they are not in Foundation, Year 1 or Year 2. Teacher participants will be excluded if they do not teach Foundation, Year 1 or Year 2 classes. Parents will be excluded if they are not a parent of child in a participating class, are under the age of 18, or do not have a good understanding of written or spoken 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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Teachers who register to participate will be allocated to the intervention (ABC-4-YC) or control (delayed intervention) condition using a computer generated block randomisation list to sequentially allocate teachers from each school. Each school will represent a new block, and participating teachers from each school will be sequentially allocated based on the order in which they register to participate.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To determine the child participant sample size, a power analysis was conducted using a medium effect size (f=0.20) for a repeated measures design with two groups, resulting in a total sample of 84 participants, however, to allow for potential attrition of approximately 25% we are aiming to recruit 120 children to the study (60 in each condition).

ANCOVA and MMRM will be used to assess how groups change over time and whether they are significantly different from each other at each time point, taking into account differences at baseline and missing data at follow-up.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Largely due to delays in recruitment and changes in researcher availability.
Date of first participant enrolment
Anticipated
28/02/2017
Actual
8/05/2017
Date of last participant enrolment
Anticipated
Actual
2/08/2017
Date of last data collection
Anticipated
Actual
12/10/2017
Sample size
Target
120
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295439 0
University
Name [1] 295439 0
La Trobe University
Country [1] 295439 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
School of Psychology and Public Health
Plenty Road & Kingsbury Drive
Melbourne VIC 3086
Country
Australia
Secondary sponsor category [1] 294257 0
None
Name [1] 294257 0
Address [1] 294257 0
Country [1] 294257 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296769 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 296769 0
Ethics committee country [1] 296769 0
Australia
Date submitted for ethics approval [1] 296769 0
23/11/2016
Approval date [1] 296769 0
19/12/2016
Ethics approval number [1] 296769 0
HEC16-124

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

Contacts
Principal investigator
Name 72002 0
Dr Stephanie R Damiano
Address 72002 0
School of Psychology and Public Health
La Trobe University
Plenty Road & Kingsbury Drive
Melbourne VIC 3086
Country 72002 0
Australia
Phone 72002 0
+61394791906
Fax 72002 0
Email 72002 0
s.damiano@latrobe.edu.au
Contact person for public queries
Name 72003 0
Stephanie R Damiano
Address 72003 0
School of Psychology and Public Health
La Trobe University
Plenty Road & Kingsbury Drive
Melbourne VIC 3086
Country 72003 0
Australia
Phone 72003 0
+61394791906
Fax 72003 0
Email 72003 0
s.damiano@latrob.edu.au
Contact person for scientific queries
Name 72004 0
Stephanie R Damiano
Address 72004 0
School of Psychology and Public Health
La Trobe University
Plenty Road & Kingsbury Drive
Melbourne VIC 3086
Country 72004 0
Australia
Phone 72004 0
+61394791906
Fax 72004 0
Email 72004 0
s.damiano@latrobe.edu.au

No information has been provided regarding IPD availability


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.