Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000890730
Ethics application status
Approved
Date submitted
18/07/2013
Date registered
9/08/2013
Date last updated
9/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
ENeRgy-Kids: An E-Health eating and nutrition intervention that will provide parents of children aged 5-12 years who have recently completed cancer treatment with skills to help deal with the changes in their child’s eating habits after cancer treatment.
Scientific title
‘ENeRgy-Kids’ : A study to assess the feasibility of implementing a parent and child-targeted e-Health diet/feeding behaviour program to improve diet quality after childhood cancer treatment.
Secondary ID [1] 282855 0
Nil
Universal Trial Number (UTN)
Trial acronym
ENeRgy-Kids
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood cancer survivor, nutrition/dietetics, feeding behaviour 289661 0
Condition category
Condition code
Diet and Nutrition 289981 289981 0 0
Other diet and nutrition disorders
Cancer 289982 289982 0 0
Children's - Leukaemia & Lymphoma
Cancer 289983 289983 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention 'ENeRgy-KIDS' is a parent and child-targeted e-Health diet/feeding behavior program. The program will consist of weekly, 90 minute E-Health treatment sessions, delivered over 6 weeks to provide diet education specific to the needs of childhood cancer patients after cancer treatment. The program will include information on how to manage child feeding behaviors, evidence-based best feeding practices by parents, healthy nutrition/diet after cancer treatment, medical long term effects of cancer treatment, healthy lifestyle now and in the future and goal setting. The program will also consist of a 15 minute child component that will deliver nutrition information and feeding therapy techniques through fun messy play and workbook activities. Sessions will be delivered through video conferencing software on the Internet (WebEx, by Cisco). WebEx combines a teleconference with a web-based video-conference and requires a phone line, a computer with standard browser and a webcam. It is a secure, password-protected videoconferencing program that allows participants access to the online system only through a personal email invitation from the study coordinator. WebEx includes an automated upcoming session reminder and can record sessions. Participants will also receive a reminder SMS on their mobile phone 24 hours before their session. Several SCH staff are trained WebEx technicians and will support the technical aspects of this study. The use of this delivery method was also following recommendations of the systematic review that suggested that if frequent session delivery is not feasible in clinic (often due to the rural location of patients), telephone or online sessions in the home environment, may be a practical alternative.

After each session the study coordinator will collect session-specific feedback through a short 10 minute online survey using Lime Survey Trademark completed by the parent participant. This will enable the study investigators to determine the feasibility and effectiveness of each individual program treatment session and module content for the parent. The information collected will be on: If participant found the session useful, what they and their child enjoyed from the session, the skills they gained from the session and any barriers (time or technological) that they may have experienced for the running of the session.
Intervention code [1] 287544 0
Lifestyle
Intervention code [2] 287545 0
Prevention
Intervention code [3] 287546 0
Behaviour
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290031 0
To evaluate the feasibility of delivering a diet and feeding program: ENeRgy-KIDS (Eating and Nutrition inteRvention post childhood cancer treatment) to childhood cancer patients who have recently competed treatment and their parents. Primary outcome measure: Overall Program feasibility (patient satisfaction and efficacy questionnaire – 15 minutes).
Feasibility of ENeRgy-KIDS will be assessed using a questionnaire developed by the research team and is based on a Likert-style and written qualitative response format successfully used in other studies from our centre. The questionnaire will ask participants how they perceived the length of time it took to complete the program, ease of completion of assessments, relevance for their situation and the perceived impact of the program and the study on their child. Participants will also be asked if they would recommend the program to other people in the same situation as themselves. They will also be given the opportunity to comment on areas which may need improvement.
Timepoint [1] 290031 0
an assessment at the end of the program (post- test assessment T2) and at a 3 month follow up time point (post-test assessment T3)
Secondary outcome [1] 303808 0
To assess the feasibility of the ENeRgy-KIDS study protocol on selected measures Dietary intake (3 pass 24 hour food recall - 20 minutes): A three-pass 24 hour dietary recall will be used to assess nutrient intake of the patient at T1, 2 and 3. This method consists of a structured interview conducted by the study coordinator who asks the adult caregiver to list everything the child ate or drank during the previous day. The three-pass 24 hour dietary recall is considered to have one of the highest validation standards for dietary assessment methods as the methods utilizes a very structured interview procedure that has a ‘3 pass method’ involving three distinct probing sessions (or passes) during the interview. The first pass will obtain a list of foods, the second pass adds detailed descriptions of the foods and the third pass reviews for missing items. This methodology is the least burden on participants, has no literacy requirements, does not allow the participant to alter food intake behaviour and can allow for the participant to report all foods consumed not just those that fall into certain sub groups such as ‘grains’ (McPherson et al 2000). The three-pass 24 hour dietary recall provides an estimate of actual dietary intake that also includes a detailed description of the food (brand, ingredients, portion size etc) (McPherson et al 2000). From this measure an accurate nutrient intake can be calculated using Foodworks (Xyris Software, 2007) for the previous day. Intake will be compared with age-matched Australian Nutrient Reference Values.

Food variety score:
Diet quality will be measured through food variety which evaluates the overall nutritional quality of an individual diet by assessing food items and groups (Drewnowski, A., et al. 1997). An increased number of food items/groups is correlated with an improved diet quality (Drewnowski, A., et al. 1997). The food variety score will be derived from the three-pass 24 hour dietary recall. The frequency of individual foods or food groups identified through the use of the three-pass 24 hour dietary recall provides the count of food items/groups for the food variety score as an absolute number.
Timepoint [1] 303808 0
baseline pre-test assessment (T1), an assessment at the end of the program (post- test assessment T2) and at a 3 month follow up time point (post-test assessment T3)
Secondary outcome [2] 304053 0
Child’s eating behaviour (fussy eating) - Children’s Eating Behaviour Questionnaire (CEBQ) (15 minutes)
The Children’s Eating Behaviour Questionnaire (CEBQ) will be used to assess the prevalence of fussy eating behaviours in this population. The CEBQ is a validated parent report measure of child eating style (Wardle, J., et al. 2003). One subscale of this questionnaire, “food fussiness” (6 items) examines parent’s reports of how selective their children are about the range of foods they accept. Response options are scored on a 5-point likert scale (1= “never” to 5= “always”). This subscale is then scored and if I child receives above the designated cut off they are considered to be a clinically fussy eater (Wardle, J., et al. 2003)
Timepoint [2] 304053 0
baseline pre-test assessment (T1), an assessment at the end of the program (post- test assessment T2) and at a 3 month follow up time point (post-test assessment T3)
Secondary outcome [3] 304054 0
Anthropometric measures (height, weight, BMI, waist circumference- 10 minutes):
Each patient’s weight and height will be measured by the study coordinator at T1, 2, and 3 to generate Body Mass Index (BMI). BMI is a quick and simple way to define obesity in children in remission from cancer, a population at risk of developing excess body fat (Murphy, A.J.2009). Abdominal adiposity will be assessed by converting waist circumference measurements to waist: height ratio. A waist: height ratio > 0.5 will be classified as a risk factor for metabolic abnormalities (Neville, K.A., et al 2006).
Timepoint [3] 304054 0
baseline pre-test assessment (T1), an assessment at the end of the program (post- test assessment T2) and at a 3 month follow up time point (post-test assessment T3)
Secondary outcome [4] 304055 0
Body composition (Bioelectrical impedance machine- Impedimed DF50 -10 minutes):
Bioelectrical Impedance (BIA) is a safe, non-invasive method to measure the electrical responses to the introduction of a low-level, alternating current in a patient, to assess their body composition by measuring fat mass and fat-free mass (Lukaski, H.C 2013). This is a simple, quick, and pain-free measurement that will be taken using a Bioelectrical impedance machine- Impedimed DF50 that is potable with electrodes attached to the child’s fingers and can calculate the proportions of fat and fat-free mass in the body in the child. This measurement of body composition and has been validated in the paediatric population (Montagnese, C., et al 2013). As this population is at risk of increased body fatness (Nysom, K., et al.2013) which can increase their risk of the metabolic syndrome, we will use BIA assessment to determine whether an increase in improvement nutritional intake can improve their body composition.
Timepoint [4] 304055 0
baseline pre-test assessment (T1), an assessment at the end of the program (post- test assessment T2) and at a 3 month follow up time point (post-test assessment T3)

Eligibility
Key inclusion criteria
Parents/carers and patients treated for childhood cancer at Sydney Children’s Hospital, who are:
- Recently off treatment (< 5 years)
- <12 years of age and of a pre or primary school cognitive development level.
- Have been clinically identified as having a maladaptive feeding behaviour of ‘fussy eating’ post childhood cancer treatment.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parent/caregiver and or child:
a) Has cognitive or other impairment as identified by their clinical team
b) Have insufficient English skills to complete the written questionnaire, as identified by their clinical team.
Have a child who has been treated for childhood cancer treatment that:
a) Is > 12 years of age
b) Is > 5 years off treatment
c) Is currently on active treatment for childhood cancer
d) Does not have a clinical maladaptive feeding disorder of ‘fussy eating’ as identified by The Children’s Eating Behaviour Questionnaire (Cooke et al 2003) or from a health professionals concerns.

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)
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): The eligible child and their parents will be identified in two ways: 1) through their participation in a previous study assessing diet quality and eating behaviours in childhood cancer patients recently off treatment conducted by the principal investigator (CF). This was initially used to identify potential participants, through the validated measure: ‘The Children’s Eating Behaviour Questionnaire CEBQ’ (Wardel 2001 et al), which identified ‘fussy eating’ behaviours in children who have recently completed cancer treatment at SCH. The study found that 55% (n=22) children were clinically defined by the CEBQ to have a fussy eating feeding disorder. Fussy eating involves children with a significant decrease in food range/variety, often consuming less than 10 different types of fruit, vegetables, proteins and carbohydrates (Jacobi et al 2002). 2) Children will also be invited to participate if either the parents or a health professional (dietician, oncologist, psychologist) have identified concerns about the feeding behaviours and range of dietary intake.

Once identified from the previous study results, parents’ concerns or a health practitioner’s concerns, the principal investigator, Ms Fleming, will liaise with clinical staff at the participating oncology centre (SCH). This will be to ensure that identified potential participants are: a) appropriate to approach due to social and possible child protection issues b) all patients approached at the clinic have recently finished treatment and meet the study eligibility criteria and c) have not recently relapsed. Ms Fleming will then obtain contact/postal details for identified eligible participants from the participating oncology centre and potential participating families will be posted the study package.

The identified eligible families will be approached to participate in the study though a mailed personalised invitation letter from their oncologist explaining why they have been approached and what the study is about. Potential participating families will also be sent a consent form. Participating families can choose to participate in the study by returning the consent form in a supplied reply paid envelope or contact the study coordinator (contact details provided on information sheet) to ask any questions they may have about the research and the ENeRgy-KIDS program. As most child participants will be less than
The study coordinator (Catharine Fleming) will contact all parent participants who return the study consent form to confirm that they have read and understood the eligibility criteria written on the consent form and to address internet access issues. At this time it will be established that in order to participate they will need to complete three assessment time points (T1, T2 &T3) face to face in the clinic, to allow for study investigators to collect pre and post program information that involve physical non-invasive anthropometric measurements. In order to accommodate rural families that need to travel to SCH this face to face assessment will be aligned with the child’s next follow up appointment in the oncology clinic at SCH. This is plausible as patients that have recently completed cancer treatment still attended regular (3-6 monthly) follow up appointments and this will determine when their T1 assessment can take place. It will also be explained to parents that this assessment will provide an additional eligibility screening point to confirm the eligibility of their child for the program. This assessment will provide a re assessment of the CEBQ ‘fussy eating’ score and screen the child’s development level to ensure that no significant change (decrease in food fussiness) has occurred since they participated in the last study and will determine if they are still likely to benefit from these programs. This initial telephone conversation will also establish if the participant requires any additional IT equipment (laptop, internet connection, webcam) that they can borrow through the study centre. If required these items will then be posted through registered post to the participant or they can acquire the equipment from the study coordinator at the T1 assessment point.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The feasibility of implementing ENeRgy-KIDS will be assessed by examining the flow through of the study (from start of program to T3 assessment completion), using medians and ranges at each point. A percentage of compliance at each weekly (90 minute session) and at the completion of all program components (treatment sessions and assessments T1, T2 and T3) outlined above will be compared to provide a repeated measures analysis. With this primary comparison of compliance analysis occurring through a repeated measures test, a Cochran's Q will be used to further determine study feasibility outcomes.

Qualitative data collected through open-ended questions at both the T2 and T3 assessment time points to elicit parents/carers experiences or comments regarding parents’ experiences, barriers to participation in the program and possible suggestions for improvements will be analysed using the conceptual framework of Miles and Huberman (1994) and QSR NVivo 9 will be used to organise the qualitative findings into thematic categories.

Preliminary descriptive statistics and non-parametric testing (Friedman's ANOVA) of diet variety score, fussy eating score, anthropometric measures (BMI z scores, waist circumference) and body composition will be used to assess utility of program design.
This study is a feasibility study with aiming to identify and resolve methodological issues in implementing ‘ENeRgy-Kids’ program, such as: time to complete assessments at T1, 2 and 3, session complement rate, response rate, rates of participant adherence and attrition. It is recognised that a feasibility study is not adequately powered for conclusive statistical analysis of secondary outcomes; this study will provide descriptive statistics to sufficiently identify any problems in the program methodology and allow for modification to the program for future possible larger randomized controlled trials (RCT) (Hertzog 2008).
The total target sample size is n=20 participants (comprising 10 parents/caregivers, ONLY one from each family, and 10 patients). It is anticipated that 22 families will be approached who have a child classified has having a maladaptive feeding behaviour of ‘fussy eating’. This was established from a previous study conducted by the study coordinator which reported 55% (n=22) of children participating to have a clinically classified fussy eating behaviour. Assuming a response rate of 50% and attrition rate of 20%, based on previous research by our team (Cohen et al 2011, Sansom-Daly et al 2012, Karlson et al 2009), this sample size is feasible. A sample size of 10-15 is considered sufficient for a feasibility feasibility study to provide exploratory findings which can determine a suitable research design, data collection methods and sample selection for future programs in this population(Lancaster et al 2004, Hertzog 2008)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2013
Actual
Date of last participant enrolment
Anticipated
1/04/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1331 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 7173 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 287629 0
Charities/Societies/Foundations
Name [1] 287629 0
Anthony Rothe Memorial trust
Country [1] 287629 0
Australia
Funding source category [2] 287630 0
Hospital
Name [2] 287630 0
Sydney Children's Hospital
Country [2] 287630 0
Australia
Primary sponsor type
Individual
Name
Catharine Fleming
Address
Sydney Children's Hospital
High Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 286373 0
Individual
Name [1] 286373 0
Jennifer Cohen
Address [1] 286373 0
Sydney Children's Hospital
High Street
Randwick
NSW 2031
Country [1] 286373 0
Australia
Secondary sponsor category [2] 286374 0
Individual
Name [2] 286374 0
A/P Richard Cohn
Address [2] 286374 0
Sydney Children's Hospital
High Street
Randwick
NSW 2031
Country [2] 286374 0
Australia
Secondary sponsor category [3] 286375 0
Individual
Name [3] 286375 0
Dr Claire Wakefield
Address [3] 286375 0
Sydney Children's Hospital
High Street
Randwick
NSW 2031
Country [3] 286375 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289600 0
Hunter New England Human research ethics committee
Ethics committee address [1] 289600 0
Ethics committee country [1] 289600 0
Australia
Date submitted for ethics approval [1] 289600 0
Approval date [1] 289600 0
15/05/2013
Ethics approval number [1] 289600 0
HREC/13/HNE/37

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

Contacts
Principal investigator
Name 41526 0
Ms Catharine Fleming
Address 41526 0
Kids Cancer Centre
Sydney Children's Hospital
High Street
Randwick
NSW 2031
Country 41526 0
Australia
Phone 41526 0
+61 2 9382 3115
Fax 41526 0
Email 41526 0
Catharine.Fleming@sesiahs.health.nsw.gov.au
Contact person for public queries
Name 41527 0
Catharine Fleming
Address 41527 0
Kids Cancer Centre
Sydney Children's Hospital
High Street
Randwick
NSW 2031
Country 41527 0
Australia
Phone 41527 0
+61 2 9382 3115
Fax 41527 0
Email 41527 0
Catharine.Fleming@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 41528 0
Catharine Fleming
Address 41528 0
Kids Cancer Centre
Sydney Children's Hospital
High Street
Randwick
NSW 2031
Country 41528 0
Australia
Phone 41528 0
+61 2 9382 3115
Fax 41528 0
Email 41528 0
Catharine.Fleming@sesiahs.health.nsw.gov.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

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