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Trial registered on ANZCTR


Registration number
ACTRN12611000942954
Ethics application status
Approved
Date submitted
1/09/2011
Date registered
1/09/2011
Date last updated
30/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Eating Learning Program (HELP) Study for Fussy Eaters with no major medical history
Scientific title
In children who are fussy eaters but with no major medical history, is child-focused individual operant conditioning intervention more effective than child-focused group systematic desensitisation intervention at improving dietary variety and nutrition, and decreasing maladaptive mealtime behaviours and parental stress?
Secondary ID [1] 262972 0
Nil
Universal Trial Number (UTN)
U1111-1124-2093
Trial acronym
HELP Study for Fussy Eaters with No Major Medical History
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy children who are fussy eaters, but have no major medical history (have never been hospitalized for a primary medical condition, OR have no medical diagnosis e.g. Down Syndrome) 270698 0
Condition category
Condition code
Diet and Nutrition 270870 270870 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm One: One-on-one operant conditioning therapy. Run in a 1 hour 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. 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: Small group systematic desensitisation therapy. Run in a 1 hour 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 sensory 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 sensory hierarchy (i.e. 1 parent and primary therapist in room, 2 parents and secondary therapist outside of room). 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] 269313 0
Behaviour
Intervention code [2] 269314 0
Treatment: Other
Comparator / control treatment
Natural control will be waiting for therapy. As recruitment for this study will occur in an ongoing fashion, and the data collection period will continue for a period of at least 18 months, there will be multiple opportunities to access therapy in subsequent blocks if it is not immediately available.
Control group
Active

Outcomes
Primary outcome [1] 279549 0
Adequacy of diet and overall increase in dietary variety

Assessed via 3-day weighed food diary, modified Children's Dietary Questionnaire (Magarey et al. 1999) (food frequency questionnaire) and New Food Lists, where parents indicate in an ongoing fashion how many times their child is offered new foods and the number of acceptances and rejections
Timepoint [1] 279549 0
Baseline
Immediately post-intervention
For 3 months post-intervention (parents will collect at home in an ongoing fashion until they return for a 3-month review)
Primary outcome [2] 279550 0
Growth (change in weight and height)
Timepoint [2] 279550 0
Baseline
Immediately post-intervention
3 months post-intervention
Primary outcome [3] 279551 0
Change in fat-free mass as measured by body composition measure
Measured by Bioelectrical Impedance Analysis (BIA)
Timepoint [3] 279551 0
Baseline
Immediately post-intervention
3 months post-intervention
Secondary outcome [1] 287882 0
Improvement in mealtime behaviours (%desirable vs undesirable behaviours; mealtime duration)

Measured via Behaviour Pediatrics Feeding Assessment (Adapted from Crist et al. 2001) and self-developed HELP Study: Eating Skills and Behaviours Questionnaire. Questionnaires involve parent-rated likert scales (parents rate level of concern).
Timepoint [1] 287882 0
Baseline
Immediately post-intervention
3 months post-intervention
Secondary outcome [2] 287883 0
Improvement in mealtime interaction between parent and child

Measured via Dyadic Parent-Child Interaction Coding System (Revised) (Eyberg, 1994). A video-tape is taken of the parent interacting with the child in a non-food related activity, the 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] 287883 0
Baseline
3 months post-intervention
Secondary outcome [3] 287884 0
Improvement of parental stress (overall and mealtime specific)

Measured via self developed HELP Study: Parent Perceived Feeding Stress Questionnaire and the Parenting Stress Index - Short Form (Abidin, 1995).
Timepoint [3] 287884 0
Baseline
3 months post-intervention
Secondary outcome [4] 287885 0
Increased interest in trying unfamiliar foods

Measured with Children's Picky Eating Questionnaire (Adapted from Carruth and Skinner, 2000) and New Foods Lists, where parents indicate in an ongoing fashion how many times their child is offered new foods and the number of acceptances or rejections.
Timepoint [4] 287885 0
Baseline
For 3 months post-intervention (parents will collect at home in an ongoing fashion until they return for a 3-month review)

Eligibility
Key inclusion criteria
Children with a history of ongoing fussy eating (persisting for a period of 6 months or longer) but who have never been hospitalized for a primary medical condition (e.g gastroesophageal reflux), or who have never received a medical diagnosis with significant intellectual or developmental implications (e.g. Down Syndrome).

"Fussy eating" includes:
* Limited dietary variety across the food groups
(diet currently includes less than 10 foods which are predominantly carbohydrates, 10 foods which are predominantly proteins, and 10 fruits/vegetables)
* Limited range of textures consumed (don't eat an age-appropriate range of textures; limit diet to 1 or 2 food textures; consume predominantly 'easy to eat' junk foods)
* Mealtimes are taking longer than 30 minutes
* There are problematic behaviours at mealtimes which are contributing to parental stress
Minimum age
1 Years
Maximum age
6 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children who are medically unstable: acutely unwell children who may experience a deterioration in health

Children with documented aspiration on any solid food textures (children on modified liquids will be accepted)

Children with severe malnutrition, whose primary goal of nutrition could only be achieved by supplementary tube feeding

Children with gut disorders which are not well controlled or understood (e.g. dumping syndrome)

Children with an allergy or current intolerance to more than 2 types of foods

Children whose primary health carer has a known/declared mental health condition

Children whose primary language is that other than English, or children identified as being from an Aboriginal or Torres Strait Islander background

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)
Children will need to be grouped into above and below 3 years for groups. Sealed envelopes containing 3 stratified participant numbers (i.e. >3 number 1) will be developed using a random number generator before the enrollment commences. This box will be kept under the control of a blinded colleague who will not have direct contact with any of the participants. An intake questionnaire is completed on contact with parents to determine eligibility. Parents provide written consent for their child to participate in the study if they are eligible. After initial assessment, the participants are allocated to >3 years or <3 years and allocated a participant number as per order of enrollment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As per above, sealed envelopes containing 3 (because one arm will be operating in small groups of 3) stratified participants will be developed before the study commences. A computer generated random number sequence will be used to allocate the numbers to sealed envelopes in groups of 3.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Inter-rater reliability for assessments. 10% of assessments requiring subjective scoring will be reviewed by a blind 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
Completed
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)

Funding & Sponsors
Funding source category [1] 269779 0
Hospital
Name [1] 269779 0
Queensland Children's Medical Research Institute, Royal Children's Hospital
Address [1] 269779 0
Queensland Children's Medical Research Institute, Level 4, Foundation Building, Royal Children's Hospital, Herston Road, Herston, Queensland, 4029.
Country [1] 269779 0
Australia
Funding source category [2] 269780 0
University
Name [2] 269780 0
The University of Queensland
Address [2] 269780 0
Sir Fred Schonell Drive, St. Lucia, Queensland, 4068.
Country [2] 269780 0
Australia
Funding source category [3] 269781 0
Self funded/Unfunded
Name [3] 269781 0
Jeanne Marshall
Address [3] 269781 0
Queensland Children's Medical Research Institute, Level 4, Foundation Building, Royal Children's Hospital, Herston Road, Herston, Queensland, 4029
Country [3] 269781 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Medical Research Institute
Address
Queensland Children's Medical Research Institute, Level 4, Foundation Building, Royal Children's Hospital, Herston Road, Herston, Queensland, 4029
Country
Australia
Secondary sponsor category [1] 268821 0
University
Name [1] 268821 0
The University of Queensland
Address [1] 268821 0
Sir Fred Schonell Drive, St. Lucia, Queensland, 4068.
Country [1] 268821 0
Australia
Secondary sponsor category [2] 268822 0
Government body
Name [2] 268822 0
Queensland Health
Address [2] 268822 0
Health Research Fellowship for Dr. Pamela Dodrill
Speech Pathology Department
Royal Children's Hospital
Herston Road
Herston
Queensland 4029
Country [2] 268822 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271737 0
Children's Health Services Human Research Ethics Committee
Ethics committee address [1] 271737 0
c/ Department of Paediatrics and Child Health
Level 3, Foundation Building
Royal Children's Hospital
Herston Road
Herston Queensland 4029
Ethics committee country [1] 271737 0
Australia
Date submitted for ethics approval [1] 271737 0
Approval date [1] 271737 0
12/05/2010
Ethics approval number [1] 271737 0
HREC/10/QRCH/30
Ethics committee name [2] 271738 0
Delete
Ethics committee address [2] 271738 0
Level 2, Aubigny Place
Mater Health Services,
Raymond Terrace
South Brisbane
Queensland 4101
Ethics committee country [2] 271738 0
Australia
Date submitted for ethics approval [2] 271738 0
Approval date [2] 271738 0
01/03/2011
Ethics approval number [2] 271738 0
1575C
Ethics committee name [3] 271739 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [3] 271739 0
Human Ethics Unit
The University of Queensland
St. Lucia Queensland 4068
Ethics committee country [3] 271739 0
Australia
Date submitted for ethics approval [3] 271739 0
Approval date [3] 271739 0
12/05/2010
Ethics approval number [3] 271739 0
2010000677

Summary
Brief summary
This study will be a randomised controlled trial to evaluate the clinical benefits of two feeding intervention programs for children with a history of fussy eating, but no major medical history. Baseline assessment will include parent completed questionnaires and on-site feeding and growth assessments. There are two arms of intervention. Arm One is an individual operant conditioning arm. Arm Two involves small group systematic desensitisation therapy. Both arms will involve group parent education sessions regarding nutrition, behaviour management and feeding development. Intervention will be provided in either an intensive format (10 times over the course of a week) or in a weekly format (10 times over 10 weeks) at the discretion of the parent.
Trial website
www.qcmri.org.au
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33104 0
Mrs Jeanne Marshall
Address 33104 0
Queensland Children's Medical Research Institute
Level 4, Royal Children's Hospital
Herston Road
Herston
Brisbane
Queensland, 4029
Country 33104 0
Australia
Phone 33104 0
+61 7 3636 6107
Fax 33104 0
Email 33104 0
j.marshall@uq.edu.au
Contact person for public queries
Name 16351 0
Mrs Jeanne Marshall
Address 16351 0
Queensland Children's Medical Research Institute, Level 4, Foundation Building, Royal Children's Hospital, Herston Road, Herston, Queensland, 4029
Country 16351 0
Australia
Phone 16351 0
+61 7 3636 1290
Fax 16351 0
+61 7 3636 5578
Email 16351 0
j.marshall@uq.edu.au
Contact person for scientific queries
Name 7279 0
Mrs Jeanne Marshall
Address 7279 0
Queensland Children's Medical Research Institute, Level 4, Foundation Building, Royal Children's Hospital, Herston Road, Herston, Queensland, 4029
Country 7279 0
Australia
Phone 7279 0
+61 7 3636 1290
Fax 7279 0
+61 7 3636 5578
Email 7279 0
j.marshall@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary