Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001322729
Ethics application status
Approved
Date submitted
5/10/2022
Date registered
12/10/2022
Date last updated
3/05/2023
Date data sharing statement initially provided
12/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Your Body Is Your Home: A School-Based Intuitive Eating Program for Early Adolescents
Scientific title
Your Body Is Your Home: The Feasibility of a School-Based Intuitive Eating Program for Early Adolescents
Secondary ID [1] 308046 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
disordered eating 327738 0
Condition category
Condition code
Mental Health 324806 324806 0 0
Eating disorders
Public Health 324979 324979 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The present study aims to evaluate a brief intuitive eating intervention adapted for adolescents using a single-arm crossover-style design. A non-randomised control group will be used. Allocation will be done on a convenience basis; upon their recruitment schools can select to take part in the first half of the term or the second half of the term based on their own scheduling preferences. The intervention will be facilitated face-to-face in four school classrooms (2 intervention, 2 non-randomised control) by a certified intuitive eating counsellor. In total, there will be 5x 1 hour sessions delivered weekly for five weeks. No homework or out-of-hours learning will be required. The in-class lessons will cover key intuitive eating skills and emotional regulation, and self-care tools, adapted from the evidence-based intuitive eating model (Tribole & Resch, 1995) and designed to fit within Aotearoa New Zealand's Health & Physical Education (HPE) curriculum. They will be a conducted as a series of interactive activities, including lecture-style lessons, group discussions, small group/paired activities, and creative worksheets. Adherence will be measured using session attendance checklists. The facilitator will use a scripted guide in all sessions to ensure framework adherence. Students will be in classroom groups of approximately 30 and will be provided with a student workbook designed for the purposes of this study to consolidate student learning.
Intervention code [1] 324550 0
Prevention
Comparator / control treatment
Non-randomised control groups will consist of two classrooms (group A) that will provide baseline data and have delayed access to the intervention. Group A classrooms will complete regular teacher-directed HPE lessons for the first five weeks of term (while active classroom conditions are completed) and then commence the intervention after two other classrooms (group B) have completed it. Teachers in group A will be asked to provide a brief overview of their lesson planning for the start of term so key differences can be identified between their lessons and the intervention content.
Control group
Active

Outcomes
Primary outcome [1] 332700 0
Intuitive eating assesed by the Early Adolescent Intuitive Eating Scale (IES-EA), an adaptation of the IES-2 (Tylka & Kroon Van Diest, 2013)
Timepoint [1] 332700 0
Data will be collected at four time-points, using a crossover-style design. (1) Baseline (groups A & B), (2) five weeks after baseline (group A) or end of intervention (group B), (3) end of intervention (group A) and five weeks after intervention (group B), (4) four weeks after time-point 3 (groups A & B).
Primary outcome [2] 332701 0
Positive body image and body satisfaction as measured by the Body Appreciation Scale (Avalos et al., 2005).
Timepoint [2] 332701 0
Data will be collected at four time-points, using a crossover-style design. (1) Baseline (groups A & B), (2) six weeks after baseline (group A) or end of intervention (group B), (3) end of intervention (group A) and six weeks after intervention (group B), (4) four weeks after time-point 3 (groups A & B).
Secondary outcome [1] 414407 0
Acceptability as measured by structured questions and a five-point Likert-type scale from 1 (strongly disagree) to 5 (strongly agree). Questions will index their attitudes towards the intervention as related to key components of feasibility research: accessibility and implementation, demand and practicality, and integration and expansion (Bowen et al., 2009).
Timepoint [1] 414407 0
Secondary data will be collected at the end of the intervention (at the conclusion of the final session) for both Group A and Group B.

Eligibility
Key inclusion criteria
Participants in this study are students and their teachers in English medium intermediate school settings. Schools are eligible for inclusion if they are located in the Auckland and Waikato regions of Aotearoa New Zealand and teach students aged 10-13 years.
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for data inclusion include the inability to understand English or read and respond for themselves.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/11/2022
Actual
9/01/2023
Date of last participant enrolment
Anticipated
6/01/2023
Actual
6/02/2023
Date of last data collection
Anticipated
28/04/2023
Actual
27/04/2023
Sample size
Target
100
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 25043 0
New Zealand
State/province [1] 25043 0

Funding & Sponsors
Funding source category [1] 312303 0
University
Name [1] 312303 0
The University of Auckland
Country [1] 312303 0
New Zealand
Primary sponsor type
Individual
Name
Katie Babbott
Address
The University of Auckland
Department of General Practice and Primary Health Care
Faculty of Medical and Health Sciences
Building 507, Level 3
85 Park Rd
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 313935 0
Individual
Name [1] 313935 0
Dr Marion Roberts
Address [1] 313935 0
The University of Auckland
Department of General Practice and Primary Health Care
Faculty of Medical and Health Sciences
Building 507, Level 3
85 Park Rd
Grafton
Auckland 1023
Country [1] 313935 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311672 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 311672 0
Ethics committee country [1] 311672 0
New Zealand
Date submitted for ethics approval [1] 311672 0
26/09/2022
Approval date [1] 311672 0
20/10/2022
Ethics approval number [1] 311672 0
AH24863

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

Contacts
Principal investigator
Name 121942 0
Dr Marion Roberts
Address 121942 0
The University of Auckland
Department of General Practice and Primary Health Care
Faculty of Medical and Health Sciences
Building 507, Level 3
85 Park Rd
Grafton
Auckland 1023
Country 121942 0
New Zealand
Phone 121942 0
+64 21509085
Fax 121942 0
Email 121942 0
[email protected]
Contact person for public queries
Name 121943 0
Katie Babbott
Address 121943 0
The University of Auckland
Department of General Practice and Primary Health Care
Faculty of Medical and Health Sciences
Building 507, Level 3
85 Park Rd
Grafton
Auckland 1023
Country 121943 0
New Zealand
Phone 121943 0
+64 211745044
Fax 121943 0
Email 121943 0
[email protected]
Contact person for scientific queries
Name 121944 0
Katie Babbott
Address 121944 0
The University of Auckland
Department of General Practice and Primary Health Care
Faculty of Medical and Health Sciences
Building 507, Level 3
85 Park Rd
Grafton
Auckland 1023
Country 121944 0
New Zealand
Phone 121944 0
+64 211745044
Fax 121944 0
Email 121944 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.