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Trial registered on ANZCTR


Registration number
ACTRN12611000956909
Ethics application status
Approved
Date submitted
5/09/2011
Date registered
6/09/2011
Date last updated
17/11/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Eating Learning Program (HELP) Study for Children with Feeding Difficulties
Scientific title
In children with feeding difficulties, is traditional operant conditioning intervention more effective than novel systematic desensitisation intervention at improving dietary variety and nutrition, and decreasing maladaptive mealtime behaviours and parental stress?
Secondary ID [1] 262988 0
Nil
Universal Trial Number (UTN)
U1111-1124-2919
Trial acronym
HELP Study for children with feeding difficulties
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Feeding Difficulties 270714 0
Children with a complex medical history (e.g. cardiorespiratory disease, gastrointestinal disease, history of cancer or ex-premature birth <37 weeks) where medical issues are currently well controlled. 270717 0
Children with a non-medically complex history. Children defined as non-medically complex have never received treatment by a specialist physician for a medical condition. 270718 0
Condition category
Condition code
Diet and Nutrition 270890 270890 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm One: Operant conditioning therapy. Run in a 30-60 minute individual session for 10 sessions with a primary therapist (speech pathologist or occupational therapist). Involves providing a verbal prompt to encourage consumption of spoonfuls of new food/s with positive reinforcement (verbal and/or with toys) upon consumption of these foods. Parents initially observe from behind a one-way mirror and assist in collecting information about the behaviours they are observing in their child with a second therapist. As sessions continue, parents are transitioned into the room, and are trained to offer new foods and provide positive reinforcement by the end of the therapy block. Parents will also receive standardised education about nutrition, behaviour management and feeding development.

Arm Two: Systematic desensitisation therapy. Run in a 30-60 minute individual or small group session for 10 sessions with a primary therapist (speech pathologist or occupational therapist). Involves the child being exposed to gradually more challenging modelling and play with food (based on a hierarchy of look>smell>touch>taste). Parents initially observe the sessions from behind a one-way mirror with a second therapist and assist in observing transitions and reactions for their child. As the block continues, parents are rotated in and out of the room to assist in modelling play using the hierarchy. Parents will also receive standardised education about nutrition, behaviour management and feeding development.

Therapy will be offered in an intensive format (10 times over 1 week) or in a weekly format (10 times over 10 weeks). This will be based on parent choice.
Intervention code [1] 269332 0
Behaviour
Intervention code [2] 269333 0
Lifestyle
Intervention code [3] 269334 0
Treatment: Other
Comparator / control treatment
There will be a natural control group who is on the wait-list to receive therapy. Following assessment, and in determining eligibility for intervention, these children will either be offered input via an intensive schedule (as described above) or during subsequent 10-week block. As recruitment for this study will occur in an ongoing fashion, there will be multiple opportunities for therapy even if it's not immediately available.
Control group
Active

Outcomes
Primary outcome [1] 279568 0
Adequacy of diet and overall increase in dietary variety. Assessed via 3-day weighed food diary, and a list of foods consumed ("HELP Study Current, Previous and Goal Foods") provided by the parents.
Timepoint [1] 279568 0
Baseline
Immediately post-intervention
3 months post-intervention
Primary outcome [2] 279569 0
Change in fat-free mass as measured by Bioelectrical Impedance Analysis (BIA).
Timepoint [2] 279569 0
Baseline
Immediately post-intervention
3 months post-intervention
Primary outcome [3] 279570 0
Change in growth (weight and height)
Timepoint [3] 279570 0
Baseline
Immediately post-intervention
3 months post-intervention
Secondary outcome [1] 287923 0
Improvement in mealtime behaviours (% desirable vs undesirable behaviours; mealtime duration)

Measured via Behavioural Paediatrics Feeding Assessment (Adapted from Crist et al., 2001), and self-developed HELP Study: Eating Skills and Behaviour Questionnaire. Questionnaire involves parent-rated likert scales (parents rate how often their child presents with a certain behaviour from 0 = never to 4 = always).
Timepoint [1] 287923 0
Baseline
Immediately post-intervention
3 months post-intervention
Secondary outcome [2] 287924 0
Improvement in mealtime interactions between parent and child measured via Dyadic Parent-Child Interaction Coding System (Revised) (Eyeberg, 1994). A video-tape is taken of the parent interacting with their child in a non-food related activity, a parent offering their child a preferred food and the parent offering their child a non-preferred food. All videos will be rated externally by the team psychologist who will not be working directly with the children involved.
Timepoint [2] 287924 0
Baseline
3 months post-intervention
Secondary outcome [3] 287925 0
Improvement in parental stress (overall and mealtime specific)

Measured via a self-developed HELP Study: Parent Perceived Stress Questionnaire and the Parenting Stress Index - Short form.
Timepoint [3] 287925 0
Baseline
Immediately psot-intervention
3 months post-intervention
Secondary outcome [4] 287926 0
Increase interest in trying unfamiliar foods Measured with the Children's Picky Eating Questionnaire (Adapted from Carruth and Skinner, 2000)
Timepoint [4] 287926 0
Baseline
Immediately post-intervention
3 months post-intervention

Eligibility
Key inclusion criteria
Children will be eligible for assessment to further determine suitability for participation if:
*Child is aged between 2 and 6 years
*Child must present with at least one of the following features:
1. Limited range of textures (e.g. only eats puree);
2. Limited range of foods (<10 carbohydrates, <10 proteins, <10 fruits/ vegetables);
3. Prolonged mealtime duration (>30 minutes);
4. Battles or problematic behaviour at mealtimes that are contributing to parental stress
Minimum age
2 Years
Maximum age
6 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Acutely unwell children
* Children with severe oral motor disorders/ oropharyngeal dysphagia where aspiration is occurring
* Children who are nutritionally unstable (severe malnutrition, gut malabsorption disorders, allergy/intolerance to > 2 food types).
* Children who are tube-fed
* Children whose parent/carer has a documented mental health condition

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomly generated numbers have been placed in sealed envelopes by a colleague who is not involved with the study. After children have received their initial assessment and are deemed eligible to receive intervention, the next envelope in the sequence will be opened.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random number sequence will be used to allocate the numbers to sealed envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Inter-rater reliability for assessments requiring objective scoring will be viewed by a blinded clinician. Coders for dietary variety measures and parent-child interaction measures will be blinded.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 269799 0
Hospital
Name [1] 269799 0
Lady Cilento Children's Hospital
Children's Health Queensland
Address [1] 269799 0
Speech Pathology – Allied Health Outpatients
Level 6a
Lady Cilento Children’s Hospital
501 Stanley Street, South Brisbane
Queensland
4101
Country [1] 269799 0
Australia
Funding source category [2] 290260 0
University
Name [2] 290260 0
Children's Nutrition Research Centre
Queensland Children's Medical Research Institute
The University of Queensland
Address [2] 290260 0
Old Milk Kitchen
Cnr Fourth and Back Roads
(off Bramston Terrace)
Royal Children's Hospital
Brisbane
Queensland
4029
Country [2] 290260 0
Australia
Primary sponsor type
Individual
Name
Dr Pamela Dodrill
Address
Boston Children’s Hospital
Dept of Otolaryngology & Communication Enhancement
300 Longwood Ave
Boston, MA 02115
Country
United States of America
Secondary sponsor category [1] 268833 0
Government body
Name [1] 268833 0
Children's Health Queensland
Address [1] 268833 0
Speech Pathology – Allied Health Outpatients
Level 6a
Lady Cilento Children’s Hospital
501 Stanley Street, South Brisbane
Queensland
4101
Country [1] 268833 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271757 0
Children's Health Service Human Research Ethics Committee
Ethics committee address [1] 271757 0
C / Department of Paediatrics & Child Health
Royal Children's Hospital
Herston Rd, Herston, QLD 4029
Ethics committee country [1] 271757 0
Australia
Date submitted for ethics approval [1] 271757 0
Approval date [1] 271757 0
01/03/2011
Ethics approval number [1] 271757 0
HREC/10/QRCH/30
Ethics committee name [2] 271759 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 271759 0
Human Ethics Unit
The University of Qld
St Lucia, QLD, 4068
Ethics committee country [2] 271759 0
Australia
Date submitted for ethics approval [2] 271759 0
Approval date [2] 271759 0
12/05/2010
Ethics approval number [2] 271759 0
2010000677

Summary
Brief summary
This study is a randomised clinical trial designed to evaluate the clinical benefits of two child-focused feeding intervention programs for children with feeding difficulties and restricted range of dietary intake. Baseline assessments will include parent-completed questionnaires, on-site assessment, and feeding and growth evaluations.

After assessment, participants will be randomised into one of two intervention arms. Arm One is an individual operant conditioning program. Arm Two involves systematic desensitisation therapy. Although dose of intervention will be the same (10 sessions), intervention will either be provided in a weekly (once/ week for 10 weeks), or intensive format (all 10 sessions within a week). Parents will be able to choose between weekly or intensive therapy.

Some outcome measures will be reviewed immediately post-treatment, and the participants will return for a full evaluation at 3-months post treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33118 0
Dr Pamela Dodrill
Address 33118 0
Boston Children’s Hospital
Dept of Otolaryngology & Communication Enhancement
300 Longwood Ave
Boston, MA 02115
Country 33118 0
United States of America
Phone 33118 0
+1 617 919 3648
Fax 33118 0
Email 33118 0
Pamela.Dodrill@childrens.harvard.edu
Contact person for public queries
Name 16365 0
Ms Jeanne Marshall
Address 16365 0
Speech Pathology – Allied Health Outpatients
Level 6a
Lady Cilento Children’s Hospital
501 Stanley Street, South Brisbane
Queensland
4101
Country 16365 0
Australia
Phone 16365 0
+61 7 3068 2850
Fax 16365 0
Email 16365 0
jeanne.marshall@health.qld.gov.au
Contact person for scientific queries
Name 7293 0
Ms Jeanne Marshall
Address 7293 0
Speech Pathology – Allied Health Outpatients
Level 6a
Lady Cilento Children’s Hospital
501 Stanley Street, South Brisbane
Queensland
4101
Country 7293 0
Australia
Phone 7293 0
+61 7 3068 2850
Fax 7293 0
Email 7293 0
jeanne.marshall@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
No Results