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Trial registered on ANZCTR


Registration number
ACTRN12618001570279
Ethics application status
Approved
Date submitted
13/09/2018
Date registered
19/09/2018
Date last updated
19/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of an integrated nutrition program on parental nutrition knowledge, mealtime behaviour and nutritional status of children with neurological impairments
Scientific title
Development, validation and evaluation of integrated nutrition training program for caregivers of children with neurological impairment
Secondary ID [1] 296072 0
None
Universal Trial Number (UTN)
U1111-1220-4231
Trial acronym
Integrated Nutrition Training Program (INTP)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
children with neurological impairments 309638 0
Condition category
Condition code
Neurological 308443 308443 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1- An integrated nutrition training program (INTP) which adopts multidisciplinary approach in dealing with chronic malnutrition among children with neurological impairments has shown to produce positive impacts on children feeding skills and their health outcomes (Marchand V & Motil KJ, 2006)

2- This INTP was developed based on caregivers-health specialist discussion and recent literatures (Adams et.al, 2012; Das et. al, 2017; Mlinda et. al, 2018). It was designed as an early growth failure prevention as well as treatment for those who had clinically significant growth faltering.

2- The main topic of INTP is on safe feeding components which include nutrition knowledge, good positioning, chewing & swallowing stimulation, modification of food texture, responsive feeding techniques and feeding behaviour therapy. Among activities conducted were the modification of feeding utensils, stimulating chewing ability, demonstration of communication technique at mealtime and good behaviour skill training (i.e. rewards, positive reinforcement). Materials such as INTP module, healthy plate, feeding videos, kitchen appliances for texture modification, NUK sensory brush, corner chair and examples of modified feeding utensils were used during INTP.

3- Caregivers who registered their children with neurological impairments at 35 community-based rehabilitation (CBR) centres were invited and asked to sign a consent form if they agreed to participate. Then, purposive sampling based on the CBR distance from the research institution is used to assign consented caregivers into two groups. Those attended CBR within 40km from research institution were allocated as intervention while those located more than 40 km were assigned as the control. After group assignment, caregivers in the intervention required to attend the 6-session training within 3 months period i.e. once every two weeks.

4- This training should be conducted by a dietician. In this study, a trained dietician researcher conducted 6-sessions of training based on the prepared INTP module. Twenty minutes were spent on educational talk while 40 minutes were spent on practical session/skill training, where caregivers required to implement the skills together with their children.

5- Mode of delivery - each training session was conducted in a group where dietician act as facilitator and caregivers were encouraged to implement the skills as well as participate in the group discussion

6- Each training was conducted at the nearest community-based rehabilitation centres for caregivers.

7- Caregivers required to attend 6-sessions of INTP within 3 months period whereby training session was conducted once every 2 weeks i.e. session 1 & 2 in the first month, session 3 & 4 in the second month and session 5 & 6 in the third month. Each session lasted for only one hour.

8- No individual tailoring is made in this intervention

9- No modification is made for intervention in particular

10-We tried to maintain the fidelity of the intervention by contacting each caregiver prior to the training session
Intervention code [1] 312410 0
Treatment: Other
Intervention code [2] 312411 0
Rehabilitation
Comparator / control treatment
Comparator is an active control group who received standard dietary counselling without safe feeding components and behaviour skill training

A standard dietary counselling comprises only nutrition knowledge and food texture modification. It was delivered face-to-face for 45 minutes, In this study, caregivers in the control group were visited at their home and been given dietary counselling only once throughout the study period.
Control group
Active

Outcomes
Primary outcome [1] 307424 0
Feeding-related knowledge questionnaire (FRKQ) - parent-reported. This questionnaire was developed specifically for the study and been validated.
Timepoint [1] 307424 0
Baseline
Post-intervention (within 24 hours of 3 months intervention)(primary timepoint)
Follow-up (6 months after intervention commencement)
Primary outcome [2] 307425 0
Behavioural Pediatrics Feeding Assessment Scale (BPFS) score - parent-reported
Timepoint [2] 307425 0
Baseline
Post-intervention (within 24 hours of 3 months intervention)(primary timepoint)
Follow-up (6 months after intervention commencement)
Primary outcome [3] 307428 0
Body mass index z (BAZ) score of the child.

Body mass index of the child was calculated from her/his weight (wt) and height (ht) using the following calculation; wt in kg/(ht x ht) in cm. Z-score of body mass index was generated using AnthroPlus software

The child was weighed using digital weighing scale while his/her alternative height was measured using a flexible measuring tape. In this study, due to severe child contractures, the child height was estimated using Stevenson (1995) equation based on his/her knee height measurement. Knee height was measured from the sole of the foot to the anterior surface of the femoral condyle of the thigh, with the ankle and knee each flexed to a 90° angle.
Timepoint [3] 307428 0
Baseline
Post-intervention (within 24 hours of 3 months intervention)(primary timepoint)
Follow-up (6 months after intervention commencement)
Secondary outcome [1] 351877 0
Total energy intake of the child

Child total energy intake was assessed using diet history. Diet history is a structured interview method consisting of questions about habitual intake of foods from core food groups in the last 3 to 7 days. In this study, we continued our interview by cross-checking to clarify information about their usual intake in the past 3 months. Household measures and photographic aids were used to obtain food portion. The interview was conducted by an experienced dietician. Then, the information was translated into total calorie using NutritionistPro© software
Timepoint [1] 351877 0
Baseline
Post-intervention (within 24 hours of 3 months intervention)
Follow-up (6 months after intervention commencement)
Secondary outcome [2] 351965 0
Total protein intake of the child

Child total energy intake was assessed using diet history. Diet history is a structured interview method consisting of questions about habitual intake of foods from core food groups in the last 3 to 7 days. In this study, we continued our interview by cross-checking to clarify information about their usual intake in the past 3 months. Household measures and photographic aids were used to obtain food portion. The interview was conducted by an experienced dietician. Then, the information was translated into total protein intake using NutritionistPro© software
Timepoint [2] 351965 0
Baseline
Post-intervention (within 24 hours of 3 months intervention)
Follow-up (6 months after intervention commencement)
Secondary outcome [3] 351966 0
weight z (WAZ) score of the child

The child was weighed using a digital measuring scale in his/her minimal clothing. If the child is not able to stand, he/she was weighed with their mother and whose weights were later extracted. Z-score of weight was generated using AnthroPlus software
Timepoint [3] 351966 0
Baseline
Post-intervention (within 24 hours of 3 months intervention)
Follow-up (6 months after intervention commencement)
Secondary outcome [4] 351967 0
height z (HAZ) score of the child

The child height was estimated using Stevenson (1995) equation based on their knee height measurements. Knee height was measured using a flexible measuring tape from child's sole of the foot to the anterior surface of the femoral condyle of the thigh, with the ankle and knee each flexed to a 90° angle. Z-score of height was generated using AnthroPlus Software
Timepoint [4] 351967 0
Baseline
Post-intervention (within 24 hours of 3 months intervention)
Follow-up (6 months after intervention commencement)

Eligibility
Key inclusion criteria
a) the caregiver able to understand Malay language
b) the caregiver with child aged between 2 and 18 years old
c) the caregiver with child diagnosed as neurologically impaired by specialists in paediatric neurology.
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) the caregivers of child with other disabilities (i.e. Autism, learning disabilities)
b) the caregivers with child undergoing other nutrition trials

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



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For FRKQ, BPFAS, BAZ, WAZ, HAZ, total energy and protein intakes, we used Repeated Measure ANOVA to allow for measurement of the same variables made on each subject on two or more different occasions. Data from Repeated measure ANOVA analysis were interpreted in terms of Between groups (intervention effect) and Within-subject design (time effect).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/03/2017
Date of last participant enrolment
Anticipated
Actual
18/06/2017
Date of last data collection
Anticipated
Actual
11/02/2018
Sample size
Target
80
Accrual to date
Final
109
Recruitment outside Australia
Country [1] 20843 0
Malaysia
State/province [1] 20843 0
Kelantan

Funding & Sponsors
Funding source category [1] 300663 0
University
Name [1] 300663 0
Universiti Sains Malaysia: USM 1001/CSKK/870020
Country [1] 300663 0
Malaysia
Primary sponsor type
University
Name
Universiti Sains Malaysia
Address
Universiti Sains Malaysia
11800 USM
Penang
MALAYSIA
Country
Malaysia
Secondary sponsor category [1] 300193 0
None
Name [1] 300193 0
Address [1] 300193 0
Country [1] 300193 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301446 0
Human Research Ethics Committee USM (HREC)
Ethics committee address [1] 301446 0
Ethics committee country [1] 301446 0
Malaysia
Date submitted for ethics approval [1] 301446 0
10/09/2015
Approval date [1] 301446 0
02/12/2015
Ethics approval number [1] 301446 0
USM/JEPEM/15070242

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3093 3093 0 0
/AnzctrAttachments/375993-Kelulusan Etika JEPeM, USM.pdf (Ethics approval)
Attachments [2] 3094 3094 0 0
/AnzctrAttachments/375993-Parent-report instruments for assesing feeding difficulties in children with neurological impairments - A systematic review.pdf (Publication)
Attachments [3] 3095 3095 0 0
/AnzctrAttachments/375993-Consent Form.pdf (Participant information/consent)

Contacts
Principal investigator
Name 87030 0
Ms Nurul Hazirah Jaafar
Address 87030 0
Department of Pediatrics, School Medical Sciences, Health Campus, Universiti Sains Malaysia 16150, Kubang Kerian, Kelantan
Country 87030 0
Malaysia
Phone 87030 0
+6097676523
Fax 87030 0
Email 87030 0
hazirahjaafar@iium.edu.my
Contact person for public queries
Name 87031 0
Nurul Hazirah Jaafar
Address 87031 0
Department of Pediatrics, School Medical Sciences, Health Campus, Universiti Sains Malaysia 16150, Kubang Kerian, Kelantan
Country 87031 0
Malaysia
Phone 87031 0
+6097676523
Fax 87031 0
Email 87031 0
hazirahjaafar@iium.edu.my
Contact person for scientific queries
Name 87032 0
Nurul Hazirah Jaafar
Address 87032 0
Department of Pediatrics, School Medical Sciences, Health Campus, Universiti Sains Malaysia 16150, Kubang Kerian, Kelantan
Country 87032 0
Malaysia
Phone 87032 0
+6097676523
Fax 87032 0
Email 87032 0
hazirahjaafar@iium.edu.my

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

Documents added manually
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