Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000730909
Ethics application status
Approved
Date submitted
12/07/2011
Date registered
13/07/2011
Date last updated
15/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Eating Learning Program (HELP) Study for Children Born Preterm.
Scientific title
In children with complex medical backgrounds, is child focused individual intervention more effective than child focused group intervention in improving dietary variety and overall nutrition, and decreasing maladaptive behaviours and parent stress.
Secondary ID [1] 262616 0
Nil
Universal Trial Number (UTN)
U1111-1122-9079
Trial acronym
HELP Study for Children Born Preterm
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Feeding Difficulties 268313 0
Children born preterm 268314 0
Condition category
Condition code
Diet and Nutrition 268441 268441 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 268442 268442 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Type of intervention: One-on-one behaviour modification therapy.
Delivery of intervention: To be run in individual sessions for 1 hour per week over 10 weeks (weekly schedule) or run twice daily over 1 week (intensive schedule).
Description of intervention: Involves providing verbal prompts to encourage consumption of food/s with positive reinforcement (verbal prompts with/without toy etc), upon consumption of target 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.
Arm Two: HELPing Mealtime Experience
Type of Intervention: Small group sensory desensitisation therapy.
Delivery of intervention: Run in small group sessions for 1 hour per week over 10 weeks (weekly schedule) or twice daily for 1 week (intensive schedule).
Description of intervention: Involves the child being exposed to a gradually more challenging modelling and play with food (based on a sensory heirarchy of look>touch>smell>taste). Parents initially observe the sessions from behind a one-way mirror with a second therapist and assist in observing transitions and reactions in their children. As the block continues, parents are rotated in and out of the room to assist in modeling play using the sensory hierarchy (i.e. 1 parent and primary therapist in the room; 1 parent and secondary therapist outside of the room).
Intervention code [1] 266963 0
Behaviour
Intervention code [2] 266964 0
Treatment: Other
Intervention code [3] 266965 0
Lifestyle
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 a subsequent 10-week block. As recruitment for this study will occur in an ongoing fashion, there will be multiple opportunities therapy if it is not immediately available.
Control group
Active

Outcomes
Primary outcome [1] 269198 0
Adequacy of diet and overall increase in dietary variety

Assessed via 3-day weighed food diary, Modified Children's Dietary Questionnaire (Margarey et al., 1999), and a Food Frequency Questionnaire. In addition to this, there will be a New Foods List where parents indicate, in an ongoing fashion, how many times their child is offered new foods and the number of acceptances or rejections.
Timepoint [1] 269198 0
Baseline
Mid- intervention
Immediately post-intervention
3 months post-intervention
Primary outcome [2] 269199 0
Change in fat-free mass as measured by body composition assessments.

Measured via Body Impedence Analysis and Total Body Potassium Measurement.
Timepoint [2] 269199 0
Baseline
Immediately post-intervention
3 months post-intervention
Primary outcome [3] 269200 0
Change in growth (weight and height)
Timepoint [3] 269200 0
Baseline
Immediately post-intervention
3 months post-intervention
Secondary outcome [1] 279102 0
Improvement in mealtime behaviours (% desirable vs undesirable behaviours; mealtime duration)

Measured via Behaviour 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] 279102 0
Baseline
Immediately post-intervention
3 months post-intervention
Secondary outcome [2] 279103 0
Improvement in mealtime interactions 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 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] 279103 0
Baseline
3 months post-intervention
Secondary outcome [3] 279104 0
Improvement in parental stress (overall and mealtime specific).

Measured via self-developed HELP Study: Parent Perceived Stress Questionnaire and the Parenting Stress Index - Short Form.
Timepoint [3] 279104 0
Baseline
Immediately post-intervention
3 months post-intervention
Secondary outcome [4] 279105 0
Increased interest in trying unfamiliar foods

Measured with the Children's Picky Eating Questionnaire (Adapted from Carruth and Skinner, 2000) and the New Foods List, 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] 279105 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 1 and 6 years
*Child was born at <37 weeks GA.
*Child must present with at least one of the following features:
1. Limited range of textures; 2. Limited range of foods; 3. Prolonged mealtime duration; 4. Battles or problematic behaviour at mealtimes; 5. Family stress related to mealtimes
Minimum age
1 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Acutely unwell children
*Children with documented aspiration on solid food textures (children with liquid aspiration are still eligible)
*Children who are nutritionally unstable (severe malnutrition, gut malabsorption disorders, allergy/intolerance to > 2 food types)
*Children whose parent or carer has a documented mental health condition
*Children whose family’s primary language is that other than English, or children 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)
Sealed envelopes containing three stratified participant numbers will be developed using a random number generator before enrolment 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 the parents' to determine eligibility. Parents provide written consent for their child to participate in the study if they are eligible. After initial assessment is booked with the principal investigator, the participants will then be allocated a number as per their order of enrolment. Assessment will need to be completed with a minimum of 3 participants before treatment can begin.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As per above, sealed envelopes containing three (because one arm needs to operate in at least small groups of three), participants will be developed before intervention commences. A computer generated random number sequence will be used to allocate the numbers to sealed envelopes in groups of three.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Inter-rater reliability for assessments requiring objective scoring will be reviewed 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
Suspended
Date of first participant enrolment
Anticipated
18/07/2011
Actual
20/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267428 0
University
Name [1] 267428 0
Children's Nutrition Research Centre, University of Queensland
Country [1] 267428 0
Australia
Primary sponsor type
University
Name
Children's Nutrition Research Centre, University of Queensland
Address
School of Medicine (HERSTON CAMPUS)
Level 3, RCH Foundation Building, Royal Children's Hospital, Herston Rd, Herston, QLD, 4029
Country
Australia
Secondary sponsor category [1] 266478 0
Government body
Name [1] 266478 0
Queensland Health
Address [1] 266478 0
Health Research Fellowship for Dr Pamela Dodrill
Speech Pathology Department
Royal Children's Hospital
Herston Rd
Herston, QLD 4029
Country [1] 266478 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269401 0
Children's Health Service Human Research Ethics Committee
Ethics committee address [1] 269401 0
C/ Department of Paediatrics & Child Health
Level 3, Foundation Building
Royal Children's Hospital
Herston Rd, Herston, QLD
4029
Ethics committee country [1] 269401 0
Australia
Date submitted for ethics approval [1] 269401 0
Approval date [1] 269401 0
12/05/2010
Ethics approval number [1] 269401 0
HREC/10/QRCH/30
Ethics committee name [2] 269402 0
Delete
Ethics committee address [2] 269402 0
Level 2, Aubigny Place
Mater Health Services
Raymond Terrace
South Brisbane, QLD, 4101
Australia
Ethics committee country [2] 269402 0
Australia
Date submitted for ethics approval [2] 269402 0
Approval date [2] 269402 0
01/03/2011
Ethics approval number [2] 269402 0
1575C
Ethics committee name [3] 269403 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [3] 269403 0
Human Ethics Unit
The University of Qld
St Lucia Qld 4068
Ethics committee country [3] 269403 0
Australia
Date submitted for ethics approval [3] 269403 0
Approval date [3] 269403 0
12/05/2010
Ethics approval number [3] 269403 0
2010000677

Summary
Brief summary
This study will be a randomised controlled trial to evaluate the clinical benefits and cost-effectiveness of two child-directed feeding intervention programs for children from complex medical backgrounds (cardiac, respiratory, gastrointestinal) with feeding difficulties and restricted range of oral intake (<30 foods across the food groups). Baseline assessments will include parent-completed questionnaires on-site (Herston) and feeding and growth evaluations. There are two arms of intervention. Arm One is an individual behaviour modification program. Arm Two involves small group sensory desensitization therapy. Intervention will be provided over three phases. In Phase One, interventions will be provided weekly, over a 10-week period. Phase Two will involve offering a further block of therapy, (Arm One or Arm Two), where appropriate, over a 10 week period. Phase Three will involve providing either arm one or arm two on an intensive basis.
Trial website
www2.som.uq.edu.au/som/Research/ResearchCentres/cnrc/Pages/CNRCHome.aspx
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32868 0
Dr Pamela Dodrill
Address 32868 0
Speech Pathology Department Level 4, Coles Building Royal Children's Hospital, Herston Rd, Herston BRISBANE, QLD 4000
Country 32868 0
Australia
Phone 32868 0
+61736368508
Fax 32868 0
Email 32868 0
[email protected]
Contact person for public queries
Name 16115 0
Pamela Dodrill
Address 16115 0
Speech Pathology Department Level 4, Coles Building Royal Children's Hospital, Herston Rd, Herston BRISBANE, QLD 4000
Country 16115 0
Australia
Phone 16115 0
+61 7 36368508
Fax 16115 0
Email 16115 0
[email protected]
Contact person for scientific queries
Name 7043 0
Pamela Dodrill
Address 7043 0
Speech Pathology Department Level 4, Coles Building Royal Children's Hospital, Herston Rd, Herston BRISBANE, QLD 4000
Country 7043 0
Australia
Phone 7043 0
+61736368508
Fax 7043 0
Email 7043 0
[email protected]

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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