Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000634178
Ethics application status
Approved
Date submitted
23/04/2019
Date registered
30/04/2019
Date last updated
30/04/2019
Date data sharing statement initially provided
30/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Practical mealtime strategies to increase food variety in preschool children
Scientific title
Practical mealtime strategies to increase food variety in preschool children
Secondary ID [1] 298027 0
nil known
Universal Trial Number (UTN)
U1111-1232-0933
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
feeding 312481 0
Condition category
Condition code
Diet and Nutrition 311026 311026 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The following stages of the study will generally take place during two to three weekly
visits to the child's home, dependent on family availability. All participants will progress through the following phases. Procedures will be implemented by a Masters level behavior therapist, under the supervision of a Registered Psychologist and Board Certified Behavior Analyst (BCBA)

Assessment
- Interview with parents to gather more information regarding child's feeding habits,
routines, mealtime problem behaviours and parent's feeding goals. An overall list of
12 target foods will be developed.
- Caregiver will complete the Behavioural Pediatrics Feeding Assessment Scale
(BPFAS)
- Meal observation - the caregiver will be instructed to present foods to their child,
one at a time, from an initial group of 4 target foods. They will otherwise be
instructed to act as they usually would. This meal will continue for up to 15 min, or
may end early if the caregiver requests to do so.
-
Intervention
Intervention sessions will generally be conducted by the behavior therapist 2-3 times per week, depending on
family availability. The length of each meal session will be limited to 20 minutes.
Each meal session will generally involve a group of four foods, and all foods will
initially be presented in pea-size bites. Caregivers will be requested to sit at the
table and participate in each session.
If a child leaves the table during any meal session, the experimenter will remove
access to toys or other activities and state "it's our meal time now". If the child does
not return to the table within 5-minutes, the session will be terminated for that day.
The interventions will be introduced in the following order. If after at least three
meals, the child is not consuming at least 80% of foods, we will proceed to the next
listed intervention.
Intervention A. Repeated Exposure
During repeated exposure, four foods will be prepared and ready. The experimenter
will use flashcards to randomly choose a different food to present to the child, one at
a time. The experimenter will place the food on a small plate in front of the child,
with the instruction "Try ___". The food may be presented on a spoon to the child
where required (e.g., yoghurt). If the child approaches (e.g., tastes, licks) or accepts
the food within 15-seconds, the experimenter and caregiver will provide praise
specific to the child, for instance "well done [child's name], you are doing so great".
If the child has placed the food in their mouth, after 15-s the experimenter will
instruct the child to 'show me' and check that the child has swallowed the bite of food
(praise provided). If the child has not swallowed the bite of food, they will be
instructed again to do so.
If the child does not approach or accept the food within 15-s of acceptance the
experimenter will remove the food with no comment, and then present the next food
with instruction.
Procedural integrity (i.e., treatment fidelity) will be monitored by measuring experimenter behavior against a checklist that outlines the components of treatment.

After an initial session, behavioural skills training (BST) will be used to teach parents
to conduct repeated exposure sessions on days where the experimenter is not
present. Behavioural skills training will involve reading written instructions together,
the experimenter modelling the procedures, and the caregiver and experimenter (or
child) role-playing the procedures. Caregiver adherence will be monitored by reminders (e.g., text message or email), as well as the caregiver completing a brief data sheet for each meal session.

Intervention A+B: Repeated exposure + Modelling
Repeated exposure will continue as above, though modelling will be involved as an
additional component.

Throughout the session, the experimenter and caregiver will now also have plate/s
containing the target foods and will eat small pieces. At regular time they will
express positive responses such as "oh this [name of food item] is delicious".
As described above, parents will then be instructed to add modelling to sessions
where the experimenter is not present.

Intervention A+B+C: Repeated exposure+ Modelling + Reinforcement
To identify reinforcement that is most relevant to the child, we will conduct an
assessment known as a Functional Analysis. A functional analysis looks to identify
potential reasons for food refusal, which are commonly a) caregiver attention, b)
escape from eating (the meal ending or food removed), and/or c) access to preferred
foods or activities (e.g., providing chips instead, turning TV on).
Information used from the initial interview and prior meal sessions will be used to
develop two conditions:

• CONTROL condition: the reported consequences of food refusal are absent. If the
caregiver highlighted that attention and preferred foods are often provided upon
food refusal, this condition would involve providing attention and preferred foods
continuously.

• TEST condition: the reported consequences of food refusal are present in this
condition. In comparison to the control condition example, the test condition would
involve the caregiver providing attention and a preferred food upon every instance
of food refusal.

The assessment would involve 5-minute conditions, rotating between the control and
test condition. If we see higher levels of problem behaviour in one condition over
another, this indicates potential events that are motivating for the child (such as
attention). If we do not see changes in the level of behaviour across conditions, we
will conduct further interview with the caregiver and modify conditions.
Once we have identified the relevant reinforcer, further intervention sessions will
involve providing this reinforcer upon acceptance of bites of food. The session will
continue to involve repeated exposure and modelling as described previously.
However, the child will be instructed at the start of sessions that "taking a bite" will
result in "________" (supported by a visual where required). During the session, if
the child accepts the bite within 15-s, praise will be provided as previously described,
as well as access to the reinforcer (e.g., attention and a bite of preferred food). If the
child does not accept the bite within 15-s, it will be removed with no comment and
the next food will be presented.
If this intervention level is effective for the child, we will continue with caregiver
training as described for the previous phases. As reinforcement is more detailed,
training is likely to require more time than previous interventions.
If this intervention level is not effective for the child, we will attempt further sessions
with a higher level of reinforcement (e.g., larger bites of preferred food), or reduce
the eating expectations (e.g., touching the food to the mouth results in
reinforcement). If modified procedures do not result in improvements within three
further meals, we will end the study for the child. If the caregiver consents, we will
assist with referral to an appropriate provider (e.g, speech language therapy, child
development team).
End of the study

The study will end for the child when they consume at least 80% of bites, during at
least three meals which involve 12 target foods, or by November 15th 2019,
whichever occurs earlier
At the end of the study, The BPFAS will be provided to the caregiver to be
completed again
The caregiver will be asked to complete a brief satisfaction survey
Follow-up
The experimenter will visit the family 1 and 3 month(s) after intervention. The
caregiver will be asked to conduct a meal during each visit, using foods that were
previously used during the intervention, as well as new foods.
Intervention code [1] 314257 0
Behaviour
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319827 0
Food acceptance

Food acceptance will be measured by direct observation of each occurrence, using pen-and-paper recording.
Timepoint [1] 319827 0
During each meal session conducted at:
Assessment
Intervention
Follow-up
Primary outcome [2] 319828 0
Mouth clean (swallowing)

Mouth clean will be measured by direct observation of each occurrence (asking to check inside the child's mouth, with no food larger than the size of a pea visible), using pen-and-paper recording.
Timepoint [2] 319828 0
During each meal session conducted at:
Assessment
Intervention
Follow-up
Primary outcome [3] 319829 0
Mealtime problem behaviour

Mealtime problem behaviour (e.g., whining, pushing food away) will be measured by direct observation of each occurrence, using pen-and-paper recording.
Timepoint [3] 319829 0
During each meal session conducted at:
Assessment
Intervention
Follow-up
Secondary outcome [1] 369610 0
Child rating of food preference

A visual scale (depicted smiley faces) will be presented to the child at random intervals during the meal. The child will be asked to "point to the face that shows how you feel about this food"
Timepoint [1] 369610 0
Conducted at random time points within each meal at phase below, for at least four food trials:
Assessment
Intervention
Follow-up
Secondary outcome [2] 369611 0
Scores on Behavioural Pediatrics Feeding Assessment Scale (BPFAS)
Timepoint [2] 369611 0
Scale administered at assessment and at the end of the study
Secondary outcome [3] 369612 0
Treatment satisfaction

A survey designed specifically for this study will be administered
Timepoint [3] 369612 0
Caregivers will be asked to complete a brief satisfaction survey at the end of the study

Eligibility
Key inclusion criteria
Child aged between 2 to 4 years old
Child is reported to refuse family foods
Family reside in Auckland area
Minimum age
2 Years
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Child is outside of age range
Child is already under the care of a paediatrician or dietitian with respect to eating

Family live outside of Auckland

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Single subject experimental designs will be used to demonstrate experimental control
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Single subject experimental designs use visual analysis as the primary method of analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/05/2019
Actual
Date of last participant enrolment
Anticipated
30/04/2021
Actual
Date of last data collection
Anticipated
30/11/2021
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment outside Australia
Country [1] 21426 0
New Zealand
State/province [1] 21426 0
Auckland

Funding & Sponsors
Funding source category [1] 302556 0
University
Name [1] 302556 0
University of Auckland
Country [1] 302556 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
School of Psychology
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 302463 0
None
Name [1] 302463 0
Address [1] 302463 0
Country [1] 302463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303200 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 303200 0
Ethics committee country [1] 303200 0
New Zealand
Date submitted for ethics approval [1] 303200 0
21/02/2019
Approval date [1] 303200 0
15/04/2019
Ethics approval number [1] 303200 0

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

Contacts
Principal investigator
Name 92830 0
Dr Sarah Leadley
Address 92830 0
School of Psychology
University of Auckland
Private Bag 92019
Auckland 1142
Country 92830 0
New Zealand
Phone 92830 0
+64279313551
Fax 92830 0
Email 92830 0
[email protected]
Contact person for public queries
Name 92831 0
Sarah Leadley
Address 92831 0
School of Psychology
University of Auckland
Private Bag 92019
Auckland 1142
Country 92831 0
New Zealand
Phone 92831 0
+64279313551
Fax 92831 0
Email 92831 0
[email protected]
Contact person for scientific queries
Name 92832 0
Sarah Leadley
Address 92832 0
School of Psychology
University of Auckland
Private Bag 92019
Auckland 1142
Country 92832 0
New Zealand
Phone 92832 0
+64279313551
Fax 92832 0
Email 92832 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not at this point


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.