Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000491864
Ethics application status
Approved
Date submitted
22/10/2020
Date registered
27/04/2021
Date last updated
27/04/2021
Date data sharing statement initially provided
27/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reboot Kids: feasibility of an online healthy eating intervention, delivered to parents of childhood cancer survivors aged 2-16 years old
Scientific title
Reboot Kids: a randomised controlled trial on feasibility of a behavioural medicine intervention in young cancer survivors recently off treatment
Secondary ID [1] 298539 0
Nil known
Universal Trial Number (UTN)
U1111-1259-9172
Trial acronym
NA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Paediatric cancer 313358 0
Condition category
Condition code
Cancer 311798 311798 0 0
Children's - Brain
Cancer 311799 311799 0 0
Children's - Leukaemia & Lymphoma
Cancer 311800 311800 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Reboot models a previous intervention aimed at increasing fruit and vegetable intake in over 400 Australian children (who did not receive cancer treatment). Following a parent-led interventional model, the parent (not the child) receives the intervention and is responsible for regulating the home food environment and acting as an important role model, which maintains children’s eating behaviors. To reduce geographical barriers to participation, Reboot Kids is delivered to parents at home using a combination of web-based modules and telephone sessions.

In line with the original intervention, Reboot will be delivered to only one parent by a trained health professional (either a registered psychologist or dietitian) using 4 web-based modules and 4 telephone sessions. Each web-based module takes approximately 30 to 45-minutes to complete. Parents will be encouraged to complete one web-based module every two-weeks, over eight-weeks. During each two-week module, parents are encouraged to choose specific and practical strategies suggested during the module, to try at home.

The web-based modules focus on important dietary information including national age-based dietary guidelines (e.g. child serving sizes/ recommended servings each day) and practical strategies for encouraging children to eat more fruit and vegetables. Before starting the program, parents are encouraged to read a ‘getting ready’ module, which explores the importance of healthy eating for children who have completed cancer treatment and the impact of cancer treatment on children’s taste functioning, food preferences and parent management of children’s dietary intake. In Module 1, parents are encouraged to set specific program goals, limit the availability and accessibility of non-core foods in the home and identify opportunities to increase parent providing of fruit and vegetables to children throughout the day.

In Module 2, parents are encouraged to explore their home food environment, including meal planning (planning what fruit and vegetables to busy), accessibility of ready-to-eat vegetables in the home, how often families: eat together and without TV or screens, maintain a positive and relaxed atmosphere (don’t pressure children to eat).

Module 3 explores the importance of role-modelling healthy eating to children by eating them regularly and the different responsibilities between children and adults with regards to feeding and eating. Practical strategies are encouraged such as getting children involved in the kitchen and preparing vegetables and meals in a creative, child-friendly way.

The last module reviews the topics presented in modules 1 to 3 and explores barriers to maintaining a healthy home food environment.

Parents will be offered up to four telephone sessions, every two-weeks, for up to 45-minutes. The purpose of each telephone session is to assess the participant’s psychological stress, address any issues the participant might have with the program, identify, plan and review parent strategies over the next two-weeks, highlight key educational information and assist with participant goal setting and barriers to completing home-based activities/strategies.

The program is tailored to each family as much as possible. The trial website requires participants to insert information on their child such as their age and gender. The website then provides tailored feedback on the number of fruit and vegetable servings required for a child of that age and gender. During the telephone sessions, participants will receive tailored advice from a dietitian or trained research officer based on the participants particular goals. The interventionist will also help parents to identify the most appropriate program strategies for achieving their goals and collaborate with the parent to identify specific and achievable steps for practicing these strategies at home.

Participant adherence to the website will be assessed as a measure of intervention feasibility using google analytics. This tool will collect data on the number of times a parent views a web-page, the average time spent on each web-page, and parent completion of interactive module activities.
Intervention code [1] 314789 0
Prevention
Intervention code [2] 314790 0
Lifestyle
Intervention code [3] 314791 0
Behaviour
Comparator / control treatment
The waitlist controls will serve as a comparison to the intervention group to measure differences between the two groups for changes in survivor’s vegetable consumption over the total intervention period, including the baseline assessment (may take up to 2-weeks), the intervention (8-weeks) and the post-intervention assessment (may take up to 2-weeks), resulting in a total of 12-weeks.

The wait-list group will wait for 12-weeks after which time they will be offered the Reboot Kids Program. Both the intervention and control group will receive the same questionnaires and diet history recall at the same time points, including, within one to two weeks before starting the intervention (pre) and within one to two weeks after the intervention period (post). The only exception to this will be that the intervention group will receive the program evaluation questionnaire after the intervention period has immediately finished (12-weeks). The control group will only receive the program evaluation questionnaire once they completed the intervention wait-list (12-weeks) and have completed the intervention (12-weeks), or after 24-weeks.
Control group
Active

Outcomes
Primary outcome [1] 320472 0
The primary outcome of this study is to undertake a multi-site, randomised controlled trial to evaluate the feasibility of Reboot-Kids on a national scale.

Feasibility will be assessed by the:
a) Study response rate (% of parents who were approached/invited into the study and who agree to participate and enroll. The study response rate will exclude
ineligible families (e.g. child under the age of 2 years) and families who are non-contactable (incorrect mailing address and/or telephone number).
b) Number of parent telephone sessions completed by each session (out of four)
c) Number of times a parent re-schedules a telephone interview
d) The average telephone session length
e) Number of parent drop outs during the program
f) The number of online modules completed
f) Proportion of each module content completed -All/Most/Half/Little
g) From website analytics
Timepoint [1] 320472 0
We aim to collect feasibility data at post-test (12-weeks post-enrolment).
Primary outcome [2] 320473 0
The second primary outcome in this study is to evaluate intervention acceptability among parents of young survivors of childhood cancer. Acceptability will be assessed by summing parent ratings on 34 acceptability 5-point Likert scales (ranging from strongly disagree to strongly agree).

Acceptability items will assess parent perceived satisfaction with:
a) the overall quality and amount of information provided in the program
b) the usefulness of the parent strategies suggested during the program
c) the number of web-based modules provided
d) the amount/quality of the information presented in the web-based modules,
e) reboot telephone sessions
f) assessment schedule
g) delivery methods.
Timepoint [2] 320473 0
We aim to collect acceptability data at post-test.(12-weeks post-enrolment).
Secondary outcome [1] 371762 0
Child vegetable intake will be assessed using a single 3 Pass 24 Hour Diet Recall

Child vegetable intake will be assessed by calculating the total daily number of parent-reported child vegetable servings, as a proportion of the child's age-based recommended total number of vegetable servings (based on the current 2013 National Health and Medical Research Australian Dietary Guidelines).




Timepoint [1] 371762 0
Measured at baseline and post-test. (0-weeks post-enrolment and 12-weeks post-enrolment).
Secondary outcome [2] 371763 0
Child fruit intake will be assessed using a single 3 Pass 24 Hour Diet Recall

Child fruit intake will be assessed by calculating the total daily number of parent-reported child fruit servings, as a proportion of the child's age-based recommended total number of fruit servings (based on the current 2013 National Health and Medical Research Australian Dietary Guidelines).


Timepoint [2] 371763 0
Measured at baseline and post-test (0-weeks post-enrolment and 12-weeks post-enrolment).
Secondary outcome [3] 371764 0
Home food environment score measured by Home Environment Questionnaire (developed and successfully trialed by Wyse et al in Healthy Habits study of fruit and vegetable intake of Australian children).
Timepoint [3] 371764 0
Measured at baseline and post-test (0-weeks post-enrolment and 12-weeks post-enrolment).
Secondary outcome [4] 371765 0
Parents will estimate their child's weight in kg based on the parents' current knowledge..
Timepoint [4] 371765 0
Measured at baseline and post-test. (0-weeks post-enrolment and 12-weeks post-enrolment).
Secondary outcome [5] 389286 0
Parent ratings of self-efficacy/confidence in providing healthy food to their child and managing their child's dietary habits.

A total self-efficacy score will calculated by summing parent endorsed ratings on ten, five-point self-efficacy Likert scales (ranging from strongly agree to strongly disagree).

Self-efficacy scales will include the following statements:

Over the next year, how confident are you that you can:
1) provide vegetables to your child on at least three occasions throughout the day?
2) provide a variety of vegetables to your child every week?
3) provide fruit to your child on at least two occasions throughout the day?
4) manage your child’s eating habits?
5) role-model eating vegetables to your child on at least two occasions throughout the day?
6) encourage your child to participate/help with food preparation?
7) prepare fruit and/or vegetables in an appealing way for children?
8) prepare (e.g. wash/clean/chop) ready to eat vegetables for your child every week?
9) not provide an alternative meal or snack when your child refuses to eat the healthy meal or snack
you have provided?
10) say no to your child’s demands for non-core foods (e.g. biscuits, muffins, potato crisps)?
Timepoint [5] 389286 0
Measured at post-test (12-weeks post-enrolment).

Eligibility
Key inclusion criteria
Eligible parents must be able to:
• Give informed consent
• Read English. Culturally and linguistically diverse backgrounds cannot be included with the current resourcing for this study. It is hoped to include CALD in the next phase.
• Provide the name and contact details of a trusted health professional, such as their local general practitioner or the social worker at their treating centre
• Access a telephone or Skype for the intervention telephone sessions.
• Access a computer or tablet for the intervention web-based modules. To ensure equity of access, these can be provided to a family who do not have these devices and:
• “Have a child who is a cancer survivor aged between 2 and 12 years who is considered “off treatment” (i.e. survivors who are in complete remission, and are either still on maintenance therapy, or have finished all forms of treatment)”
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parents will be excluded from the study if they:
• Have a child who is currently on active treatment, has relapsed, is in palliative care, or who is deceased.
• Have severe depression/suicidal ideation, as determined by clinical experience of the treating oncologist and or dietitian or CNC.
• Have a child who is still receiving supplementary feeding (i.e. Enteral or parental nutrition)
• Have a child who is meeting the Australian Dietary Guidelines (for their age) for fruits and vegetables, as measured by the 3 Pass 24 Hour Diet Recall.
• Are unable to access a telephone or the web based application.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An electronic randomiser (https://www.randomizer.org/) will be used to randomly allocate parents to receive the program straight-away (intervention group) or after the intervention period (12-week wait list).. Parents allocated to the intervention group will receive the program once pre-test measures are collected T0). Parents of survivors a;located to the wait-list control group will receive the program once they have completed the post-test measures (T1).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization list created through the Electronic randomiser (https://www.randomizer.org/) will be uploaded into the studies electornic database management system (REDCap). The database management system will randomly allocate parents to the intervention or wait-list control group based using the ranomisation list containing a total of 120 participant ID's, with a corresponding group allocation (1 or 2).
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
SAMPLE SIZE ESTIMATION & JUSTIFICATION
Sample size was calculated for the primary outcome of feasibility, as measured by the average number of modules completed by participants allocated to the Reboot Kids program. A group of equal size will be recruited to the waitlist arm in order to provide preliminary data on the efficacy outcomes of fruit and vegetable consumption to inform a potential phase III study.

POWER CALCULATIONS
If the average rate of module completion in the Reboot Kids program is 50% (2 out of 4 modules) or lower, the program may be considered to be infeasible. If the modules are assumed to be independent within and between participants,40 participants in the Reboot Kids program represents a sample of 160 modules. If the true average rate of module completion is at least 60% (2.4 out of 4 modules), we will have greater than 80% power to reject the null hypothesis that the rate is 50% or lower, with a one-sided significance level of 5%.[1]

A study of 40 participants also allows estimation of the proportion of participants who complete more than two modules with a 95% confidence interval of maximum width ±15%, and provide 80% power at 5% one-sided significance to detect an increase in this proportion above 50% if the true rate is 70% or higher.

Pilot data showed that the mean time to completion of a module was 55 minutes, with a standard deviation of 10. With 40 participants, the confidence interval around the mean time would have a width of 6.2 minutes.

STATISTICAL METHODS TO BE UNDERTAKEN
Participant demographic, family and clinical characteristics and study outcomes will be presented in randomised treatment groups and overall using standard descriptive statistics: frequencies and percentages for categorical variables and mean, standard deviation and range or median, interquartile range and range for continuous variables.

The primary analysis will include all participants allocated to the Reboot Kids program. The average rate of module completion will be estimated and presented with a one-sided 95% confidence interval based on the binomial distribution. If this confidence interval includes a rate of 50%, we cannot reject the null hypothesis that the program is infeasible.

Summary statistics for the other feasibility outcomes will also be calculated for participants in the Reboot Kids program, and presented with 95% confidence intervals as appropriate.

Based on pilot data, the planned sample size will not have sufficient power for a formal comparison of changes in fruit and vegetable consumption between the intervention and waitlist groups, and hence analysis of these outcomes will focus on descriptive statistics that will inform the design of a potential phase III study examining the efficacy of the Reboot Kids program.

[1] Hatcher, R.L. and J.A. Gillaspy, Development and validation of a revised short version of the working alliance inventory. Psychotherapy Research, 2006. 16(1): p. 12-25.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/07/2020
Date of last participant enrolment
Anticipated
23/07/2022
Actual
Date of last data collection
Anticipated
27/10/2022
Actual
Sample size
Target
80
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 14024 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 14026 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 26814 0
2031 - Randwick
Recruitment postcode(s) [2] 26816 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 303085 0
Charities/Societies/Foundations
Name [1] 303085 0
Cancer Council NSW
Country [1] 303085 0
Australia
Funding source category [2] 307010 0
Charities/Societies/Foundations
Name [2] 307010 0
The Kids Cancer Project
Country [2] 307010 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Behavioural Sciences Unit, Kids Cancer Centre
Address
Kids Cancer Centre, Level 1 South, Sydney Children's Hospital, High Street, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 307580 0
Hospital
Name [1] 307580 0
Monash Children's Hospital
Address [1] 307580 0
246 Clayton Rd, Clayton VIC 3168
Country [1] 307580 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303630 0
The Sydney Children's Hospitals Network Human Research Ethics Committee (SCHN HREC)
Ethics committee address [1] 303630 0
Ethics committee country [1] 303630 0
Australia
Date submitted for ethics approval [1] 303630 0
Approval date [1] 303630 0
17/10/2018
Ethics approval number [1] 303630 0

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

Contacts
Principal investigator
Name 94326 0
Prof Claire Wakefield
Address 94326 0
Kids Cancer Centre, Level 1 South, Sydney Children's Hospital, High Street, Randwick NSW 2031
Country 94326 0
Australia
Phone 94326 0
+61 0425336571
Fax 94326 0
Email 94326 0
[email protected]
Contact person for public queries
Name 94327 0
Jennifer Cohen
Address 94327 0
Kids Cancer Centre, Level 1 South, Sydney Children's Hospital, High Street, Randwick NSW 2031
Country 94327 0
Australia
Phone 94327 0
+61 405153595
Fax 94327 0
Email 94327 0
[email protected]
Contact person for scientific queries
Name 94328 0
Jennifer Cohen
Address 94328 0
Kids Cancer Centre, Level 1 South, Sydney Children's Hospital, High Street, Randwick NSW 2031
Country 94328 0
Australia
Phone 94328 0
+61 405153595
Fax 94328 0
Email 94328 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data of published results only.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it (only in publications)
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Data collected from this trial can be obtained by emailing the principal investigator ([email protected]) or by reading the published trial manuscript (to be submitted within 12-months of trial completion).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2397Study protocol    377817-(Uploaded-27-04-2021-15-11-45)-Study-related document.docx
2398Informed consent form    377817-(Uploaded-09-04-2021-16-01-19)-Study-related document.docx
2399Ethical approval    377817-(Uploaded-10-03-2021-11-03-44)-Study-related document.pdf



Results publications and other study-related documents

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