Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000332426
Ethics application status
Approved
Date submitted
4/04/2025
Date registered
17/04/2025
Date last updated
17/04/2025
Date data sharing statement initially provided
17/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing the Body Blocks Program: Helping Early Childhood Educators Support Children's Positive Body Image
Scientific title
Impact of the Body Blocks Program on Early Childhood Educators’ Knowledge and Competency for Promoting Positive Body Image: A Randomised Controlled Trial
Secondary ID [1] 314133 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 336942 0
Body dissatisfaction 336943 0
Eating Disorders 336944 0
Condition category
Condition code
Mental Health 333414 333414 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Body Blocks by The Embrace Collective (https://theembracehub.com/body-blocks-by-embrace-kids/) is a universal prevention program for early childhood educators that aims to prevent body image issues in young people by getting in early with messages of body appreciation. The program aims to provide knowledge and strategies for early learning educators to support young children to develop positive relationships with food, movement and their bodies. The program targets educators working with children aged zero to eight years of age and consists of 7 x 5-minute online evidence-based and inspirational modules, which can be completed in their entirety or in a self-paced manner. The modules include practical strategies designed to be easily implemented. The program was intentionally designed be succinct, to be completed in short work breaks, allowing for reflection and integration into practice.
The seven modules cover the following topics:
1. Body Talk: Avoiding negative body talk; using non-appearance-based compliments; treating movement as fun; reframing diet talk
2. Body Talk & Kids: Helping kids develop a positive body image; talking about what bodies can do and focusing on functionality; avoiding praising appearance. Activities to support educators to help kids develop positive body image focusing on unique body strengths and non-physical features.
3. Playtime: Aiming to teach children: (1) we appreciate their positive skills and qualities (and they can too); (2) what’s on the inside is more important than what is on the outside; (3) lots of people look different and can-do different things; (4) we accept them just as they are.
4. Food Talk: Importance of avoiding labelling food (as either good or bad, junk food); focusing on the joy of food and its function; ideas on how to update food-based activities (i.e., food collages, food I spy; food Bingo).
5. Mealtimes: Supporting children to build positive relationships with food and eating by: (1) getting curious during mealtimes; (2) bringing all five senses into meals; (3) encouraging kids to listen to their bodies; (4) remembering: “I provide, they decide!”; (5) speaking about all foods in a positive way.
6. Home time: How to support parents and family to build their children’s body image; Body Blocks guide for parents’ information sheet; communicating to parents the information educators’ have learnt through the program and what positive messages they are implementing.
7. Me time: How to support educators to build their own self-compassion and self-care practices and practice being kinder to themselves instead of self-critical.

Participants had 1-week after randomization to complete the 7x5 minute modules. To assess adherence to the intervention, participants were asked qualitative questions such as "What were the key takeaway messages from the Body Blocks program?"
Intervention code [1] 330726 0
Prevention
Intervention code [2] 330794 0
Behaviour
Comparator / control treatment
Waitlist control. The waitlist group were provided with access to the Body Blocks materials upon completion of their 4-week follow-up survey.
Control group
Active

Outcomes
Primary outcome [1] 340994 0
Body Image Knowledge
Timepoint [1] 340994 0
baseline, 1-week post randomization (primary endpoint) and 4 weeks post randomization
Primary outcome [2] 340995 0
Competence and Awareness of positive body image (composite primary outcome)
Timepoint [2] 340995 0
baseline, 1-week post randomization (primary endpoint)
Secondary outcome [1] 445727 0
Body image self-efficacy
Timepoint [1] 445727 0
baseline, 1-week post randomization and 4 weeks post randomization
Secondary outcome [2] 445728 0
Body appreciation
Timepoint [2] 445728 0
baseline, 1-week post randomization and 4 weeks post randomization
Secondary outcome [3] 445729 0
Functionality appreciation
Timepoint [3] 445729 0
baseline, 1-week post randomization and 4 weeks post randomization
Secondary outcome [4] 445730 0
Fat attitudes
Timepoint [4] 445730 0
baseline, 1-week post randomization and 4 weeks post randomization
Secondary outcome [5] 445731 0
Body positive work setting
Timepoint [5] 445731 0
baseline, 1-week post randomization and 4 weeks post randomization

Eligibility
Key inclusion criteria
Eligibility criteria included consent from ELC director and minimum of two or more staff members expressing interest in participating in the research trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria.

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 was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was conducted in a 1:1 ratio using the RAND formula list procedure in Excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Linear Mixed Model (LMM) analyses were performed to evaluate between group changes in knowledge and attitudes over time with fixed effects of group, time and interaction between group and time. LMM analyses are robust in handling missing data and unbalanced designs in repeated measures research (Nich et al., 1997), using estimation maximization (EM) for observed and missing data based on maximizing likelihood for population parameters as a function of observed data (Norusis, 2007). Thus, all participants who completed the baseline survey (regardless of missing data at follow-up) are included in the data analyses which is not possible with traditional ANOVA techniques (Gueorguieva et al., 2004).
Moderator analyses additionally included fixed effects for moderator, group × moderator, time × moderator and group × time × moderator. Potential moderators of change in knowledge and awareness included: age category (0 = below 40; 1 = above 40), years worked in the profession (0 = less than 15 years; 1 = more than 15 years), SEIFA category (0 = SEIFA score below 1000; 1 = SEIFA score above 1000), educators’ body appreciation (0 = below sample mean of 3.41; 1 = above sample mean of 3.41), educators’ functionality appreciation (0 = below sample mean of 4.13; 1 = above sample mean of 4.13) and lastly educators’ positive fat attitudes as measured by the size acceptance (0 = below sample mean of 5.8; 1 = above sample mean of 5.8) and critical health subscales (0 = below mean of 5.7; 1 = above mean of 5.7).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/05/2024
Date of last participant enrolment
Anticipated
Actual
29/10/2024
Date of last data collection
Anticipated
Actual
6/12/2024
Sample size
Target
170
Accrual to date
Final
221
Recruitment in Australia
Recruitment state(s)
QLD,SA

Funding & Sponsors
Funding source category [1] 318642 0
Government body
Name [1] 318642 0
The Australian Federal Government Department of Health and Aged Care
Country [1] 318642 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Embrace Collective
Address
Country
Australia
Secondary sponsor category [1] 321070 0
University
Name [1] 321070 0
Flinders University
Address [1] 321070 0
Country [1] 321070 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317252 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 317252 0
Ethics committee country [1] 317252 0
Australia
Date submitted for ethics approval [1] 317252 0
05/04/2024
Approval date [1] 317252 0
03/05/2024
Ethics approval number [1] 317252 0
HREC6484

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

Contacts
Principal investigator
Name 140470 0
Prof Ivanka Prichard
Address 140470 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country 140470 0
Australia
Phone 140470 0
+61 8 82013713
Fax 140470 0
Email 140470 0
[email protected]
Contact person for public queries
Name 140471 0
Ivanka Prichard
Address 140471 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country 140471 0
Australia
Phone 140471 0
+61 8 82013713
Fax 140471 0
Email 140471 0
[email protected]
Contact person for scientific queries
Name 140472 0
Ivanka Prichard
Address 140472 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country 140472 0
Australia
Phone 140472 0
+61 8 82013713
Fax 140472 0
Email 140472 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.