Picky EatingPEatersNCT05445193
PEaters Choice™: Nutrition Intervention Module for Picky Eaters
A study testing PEaters Choice Module in people with Picky Eating, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
Picky eaters (PE) are defined as individuals with a lack of diversity in food intake and fear of trying new foods which generally leads to malnutrition. Globally, between 20% to 55% of children worldwide are being reported as PE. Malaysia particularly has 31.8% PE children. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Picky Eating
- What is being tested?
- PEaters Choice Module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteMalaysia
- Study dates
- Mar 2023to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects are between three and five years old
- Subjects had PE problems (screened using the CEBQ)
Who cannot join
- subject has clinical health problems such as autism, down syndrome, global developmental delay, dyslexia, or any health problem interfering with eating habits.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
UKM Specialist Children's Hospital
Kuala Lumpur, Kuala Lumpur, 56000
Nur Hana Hamzaid, +03-9289 7511 ext. 7080, hanahamzaid@ukm.edu.my
Mohd Shah Kamarudin
About this study
Official title: PEaters Choice™: Randomized Control Trial to Improve Picky Eating Behaviour Among Children Aged 3-5 Years
Picky eaters (PE) are defined as individuals with a lack of diversity in food intake and fear of trying new foods which generally leads to malnutrition. Globally, between 20% to 55% of children worldwide are being reported as PE. Malaysia particularly has 31.8% PE children. To date, limited comprehensive modules on dietary recommendations are designed to help parents and/or primary healthcare workers to address this issue. This study is a single-blind randomized controlled trial to evaluate the effectiveness of PEaters Choice™ designed for PE children aged three to five years, with the objective to increase the food repertoire of the children. The PEaters Choice™ is a 12-week intervention program designed for mother, father or guardian-child dyads. The dyads will be divided into two groups; Intervention and Control Group. This trial will require each group to complete a list of commonly eaten foods, Child Eating Behavior Questionnaires, and a set of anthropometric data. Intervention groups will then follow three phases of the intervention program. This module suits primary healthcare settings, helping parents or guardians strategize meal planning, hence lowering the risk of malnutrition among PE children.
Read the detailed description
The study will be conducted at the UKM Specialist Children's Hospital (HPKK UKM) in Kuala Lumpur to simulate real-life situations for this module. All briefings, therapies, and activities will be conducted in this setting. Considering several factors, especially subjects' commitment to attend the prescribed session, the selected area to participate in the study is a 5km radius from HPKK UKM.
The study information sheet and consent form are written in Malay, the Malaysian national language, and in the English language. The head researcher is responsible for the consent process and answering all relevant questions. However, other researchers will also assist in conveying this information from time to time. After the briefing session, mother, father or guardian will be given time to understand and ask any questions related to the study. If the parents or guardians feel it is necessary to take a longer time before making a decision, they may also take the study information form and consent form home.
Sample size calculation using the G-Power program (95% confidence interval, 80% power) found a minimum of 138 subjects required. The study sample was increased by 10%, considering the dropout factors to 154 subjects (77 people for each group).
The dyads who have consented to participate in the study will be placed in the same age nursery or kindergartens group and randomly selected to participate in intervention groups. Children in the same nursery/kindergarten will receive the same intervention. As the intervention will be conducted by the researcher, the dyads will not be informed (blinded) of their type of intervention.
The research team will manage all data. Data will be entered into the SPSS program by the researcher and reviewed by the head researcher. Questionable data will be confirmed with original forms or relevant sources. Outlier data that is deemed unreasonable will be removed and marked as missing.
Most of the questionnaires will be filled out by mothers, fathers or guardians, in ensuring they understand the questions correctly. To avoid data loss, each form will be carefully reviewed once completed by mothers, fathers or guardians. Weighing scales and stadiometers will always be calibrated using standard weights and rulers before weight and height measurements are taken. The head researcher will check 10% of the BMI calculation and nutritional status as a quality control measure.
Data will be analyzed using the SPSS program. Using mixed ANOVA, the investigators compared the list of foods eaten (food repertoire) before, during, and after the intervention between the two groups to evaluate the impact of the intervention. On the Child Eating Behavior Questionnaires, the comparison of eight primary constructs scores between the two groups was also accomplished with mixed ANOVA. A similar statistical analysis was used to assess the nutritional status of the intervention and control groups.
All data will be kept in a safe location that only the research team will have access to. Password protection will be implemented on all user computers. Once the data is no longer required for this study, it will be destroyed. After the trial ends, the data will be kept for at least three years. The trial data will be disposed of in compliance with the Malaysian Good Clinical Practice Guidelines 2018, which will be followed.
The procedure in this study will not involve any invasive process and provided only minimal risk to the subjects. Therefore, the subjects will continue participating in the study for 12 weeks. If any subject fails to attend two consecutive therapy/activity sessions and does not attend three sessions in total, the subject will be removed from the study. However, the final decision to discontinue the subject will be made after discussion with the research team members.
- Conditions
- Picky Eating
- Being tested
- PEaters Choice Module
- Keywords
- picky eaters, food repertoire, children eating behaviour, nutrition intervention module
- Medical subject headings
- Food Fussiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEaters Choice ModuleBehavioural
There will be nine sessions conducted throughout the intervention period, which include module activity, assessment sessions and follow-up sessions. This module will have four primary sub modules (SM): SM1- An overview of picky eaters, SM2-Healthy eating for children, SM3-Parental Strategies and SM4- Sensory perception.
| Study group | Role | What they receive |
|---|---|---|
| Module PEaters Choice™ | Experimental | Using module that will be develop Receives: Behavioral: PEaters Choice Module |
| Standard nutrition information | No intervention | No intervention done, just a standard information about nutrition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of food repertoire from baseline at sixth weeks
List of food eaten by the subject
Measured: The list will be collected at the sixth weeks.
Change of food repertoire from baseline at 12th weeks
List of food eaten by the subject
Measured: The list will be collected the 12th weeks.
Secondary outcomes (10)
Change of children's eating behaviors (CEBQ) from baseline at sixth weeks
CEBQ is an instrument used to identify eating behaviors for children. There are eight primary constructs: 1) food responsiveness 2) enjoyment of food 3) emotional-overeating 4) desire to drink 5) satiety responsiveness 6) slowness in eating 7) emotional under-eating 8) food fussiness. Each question must be answered using a Likert scale with a choice of 5 answers, namely never (1), rarely (2), sometimes (3), often (4), and always (5). A high average score for each construct indicates a high intensity for the behaviour.
Measured: It will be collected at the sixth weeks
Change of children's eating behaviors (CEBQ) from baseline at 12th weeks
CEBQ is an instrument used to identify eating behaviors for children. There are eight primary constructs: 1) food responsiveness 2) enjoyment of food 3) emotional-overeating 4) desire to drink 5) satiety responsiveness 6) slowness in eating 7) emotional under-eating 8) food fussiness. Each question must be answered using a Likert scale with a choice of 5 answers, namely never (1), rarely (2), sometimes (3), often (4), and always (5). A high average score for each construct indicates a high intensity for the behaviour. The construct used in the CEBQ is food fussiness, with six questions to assess PE behaviour. Children were categorized as PE if they obtained a mean value of three and above
Measured: It will be collected at the 12th weeks
Change of weight-for-age (z-scores) from baseline at sixth weeks
Weight and height will be collected and weight-for-age (z-scores) will be assessed through a WHO Anthro Software.
Measured: It will be collected at the sixth weeks
Change of weight-for-age (z-scores) from baseline at 12th weeks
Weight and height will be collected and weight-for-age (z-scores) will be assessed through a WHO Anthro Software.
Measured: It will be collected at the 12th weeks
Change of height-for-age (z-scores) from baseline at sixth weeks
Weight and height will be collected and height-for-age (z-scores) will be assessed through a WHO Anthro Software.
Measured: It will be collected at the sixth weeks
Change of height-for-age (z-scores) from baseline at 12th weeks
Weight and height will be collected and height-for-age (z-scores) will be assessed through a WHO Anthro Software.
Measured: It will be collected at the 12th weeks
Change of weight-for-height (z-scores) from baseline at sixth weeks
Weight and height will be collected and weight-for-height (z-scores) will be assessed through a WHO Anthro Software.
Measured: It will be collected at the sixth weeks
Change of weight-for-height (z-scores) from baseline at 12th weeks
Weight and height will be collected and weight-for-height (z-scores) will be assessed through a WHO Anthro Software.
Measured: It will be collected at the 12th weeks
Change of BMI-for-age (z-scores) from baseline at sixth weeks
Weight and height will be collected and Body Mass Index (BMI) is calculated from weight and height readings. Then, BMI-for-age will be assessed through a WHO Anthro Software.
Measured: It will be collected at the sixth weeks
Change of BMI-for-age (z-scores) from baseline at 12th weeks
Weight and height will be collected and Body Mass Index (BMI) is calculated from weight and height readings. Then, BMI-for-age will be assessed through a WHO Anthro Software.
Measured: It will be collected at the 12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study startMar 2023 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Picky EatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is single-blinded, with balance randomization (1:1) and parallel-group design. Dyads will be recruited from chosen nurseries and kindergartens. Following that, the dyads will be randomly assigned to either an intervention group or a controlled group by using Microsoft Excel Random Number Generator. Dyads will then fill out the sociodemographic information form, the Child Healthy Eating Knowledge Questionnaire, and the food intake form. The research team will also measure the children's weight and height using standard methods. Next, the nutritional status of each child is assessed by using WHO Anthro Software version 3.2.2.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nur Hana Hamzaid, National University of Malaysia
- Investigators
- Nur Hana Hamzaid, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445193
- Sponsor's protocol ID
- PEatersChoice_NUMas
- Acronym
- PEaters
- Status last verified
- Jul 2022
- First submitted
- 22 Jun 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the research team and the Research Ethics Committee (REC), UKM can access this data. Data will be reported collectively without reference to individuals. Therefore subject identity and personal data will be kept confidential.
Publications
Goh DY, Jacob A. Perception of picky eating among children in Singapore and its impact on caregivers: a questionnaire survey. Asia Pac Fam Med. 2012 Jul 20;11(1):5. doi: 10.1186/1447-056X-11-5.
PubMed 22816553Li Z, van der Horst K, Edelson-Fries LR, Yu K, You L, Zhang Y, Vinyes-Pares G, Wang P, Ma D, Yang X, Qin L, Wang J. Perceptions of food intake and weight status among parents of picky eating infants and toddlers in China: A cross-sectional study. Appetite. 2017 Jan 1;108:456-463. doi: 10.1016/j.appet.2016.11.009. Epub 2016 Nov 4.
PubMed 27825943Machado BC, Dias P, Lima VS, Campos J, Goncalves S. Prevalence and correlates of picky eating in preschool-aged children: A population-based study. Eat Behav. 2016 Aug;22:16-21. doi: 10.1016/j.eatbeh.2016.03.035. Epub 2016 Apr 5.
PubMed 27077700Mohd Hanapi, H. & Mohd Fahmi Teng, N. I. 2022. Picky Eating Behaviour and Nutritional Status of Preschool Children in Kuala Selangor, Malaysia. Mal J Med Health Sci 18(1): 145-150.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEaters Choice™: Randomized Control Trial to Improve Picky Eating Behaviour Among Children Aged 3-5 Years
- ClinicalTrials.gov ID
- NCT05445193
- Acronym / sponsor ID
- PEaters / PEatersChoice_NUMas
- Conditions
- Picky Eating
- Keywords
- picky eaters, food repertoire, children eating behaviour, nutrition intervention module
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Picky eaters (PE) are defined as individuals with a lack of diversity in food intake and fear of trying new foods which generally leads to malnutrition. Globally, between 20% to 55% of children worldwide are being reported as PE. Malaysia particularly has 31.8% PE children. To date, limited comprehensive modules on dietary recommendations are designed to help parents and/or primary healthcare workers to address this issue. This study is a single-blind randomized controlled trial to evaluate the effectiveness of PEaters Choice™ designed for PE children aged three to five years, with the objective to increase the food repertoire of the children. The PEaters Choice™ is a 12-week intervention program designed for mother, father or guardian-child dyads. The dyads will be divided into two groups; Intervention and Control Group. This trial will require each group to complete a list of commonly eaten foods, Child Eating Behavior Questionnaires, and a set of anthropometric data. Intervention groups will then follow three phases of the intervention program. This module suits primary healthcare settings, helping parents or guardians strategize meal planning, hence lowering the risk of malnutrition among PE children.
Detailed description
The study will be conducted at the UKM Specialist Children's Hospital (HPKK UKM) in Kuala Lumpur to simulate real-life situations for this module. All briefings, therapies, and activities will be conducted in this setting. Considering several factors, especially subjects' commitment to attend the prescribed session, the selected area to participate in the study is a 5km radius from HPKK UKM.
The study information sheet and consent form are written in Malay, the Malaysian national language, and in the English language. The head researcher is responsible for the consent process and answering all relevant questions. However, other researchers will also assist in conveying this information from time to time. After the briefing session, mother, father or guardian will be given time to understand and ask any questions related to the study. If the parents or guardians feel it is necessary to take a longer time before making a decision, they may also take the study information form and consent form home.
Sample size calculation using the G-Power program (95% confidence interval, 80% power) found a minimum of 138 subjects required. The study sample was increased by 10%, considering the dropout factors to 154 subjects (77 people for each group).
The dyads who have consented to participate in the study will be placed in the same age nursery or kindergartens group and randomly selected to participate in intervention groups. Children in the same nursery/kindergarten will receive the same intervention. As the intervention will be conducted by the researcher, the dyads will not be informed (blinded) of their type of intervention.
The research team will manage all data. Data will be entered into the SPSS program by the researcher and reviewed by the head researcher. Questionable data will be confirmed with original forms or relevant sources. Outlier data that is deemed unreasonable will be removed and marked as missing.
Most of the questionnaires will be filled out by mothers, fathers or guardians, in ensuring they understand the questions correctly. To avoid data loss, each form will be carefully reviewed once completed by mothers, fathers or guardians. Weighing scales and stadiometers will always be calibrated using standard weights and rulers before weight and height measurements are taken. The head researcher will check 10% of the BMI calculation and nutritional status as a quality control measure.
Data will be analyzed using the SPSS program. Using mixed ANOVA, the investigators compared the list of foods eaten (food repertoire) before, during, and after the intervention between the two groups to evaluate the impact of the intervention. On the Child Eating Behavior Questionnaires, the comparison of eight primary constructs scores between the two groups was also accomplished with mixed ANOVA. A similar statistical analysis was used to assess the nutritional status of the intervention and control groups.
All data will be kept in a safe location that only the research team will have access to. Password protection will be implemented on all user computers. Once the data is no longer required for this study, it will be destroyed. After the trial ends, the data will be kept for at least three years. The trial data will be disposed of in compliance with the Malaysian Good Clinical Practice Guidelines 2018, which will be followed.
The procedure in this study will not involve any invasive process and provided only minimal risk to the subjects. Therefore, the subjects will continue participating in the study for 12 weeks. If any subject fails to attend two consecutive therapy/activity sessions and does not attend three sessions in total, the subject will be removed from the study. However, the final decision to discontinue the subject will be made after discussion with the research team members.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is single-blinded, with balance randomization (1:1) and parallel-group design. Dyads will be recruited from chosen nurseries and kindergartens. Following that, the dyads will be randomly assigned to either an intervention group or a controlled group by using Microsoft Excel Random Number Generator. Dyads will then fill out the sociodemographic information form, the Child Healthy Eating Knowledge Questionnaire, and the food intake form. The research team will also measure the children's weight and height using standard methods. Next, the nutritional status of each child is assessed by using WHO Anthro Software version 3.2.2.
| Arm | Type | Receives |
|---|---|---|
| Module PEaters Choice™ | Experimental | Behavioral: PEaters Choice ModuleUsing module that will be develop |
| Standard nutrition information | No intervention | –No intervention done, just a standard information about nutrition. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Subjects are between three and five years old
- Subjects had PE problems (screened using the CEBQ)
Key exclusion criteria (1 listed)
- subject has clinical health problems such as autism, down syndrome, global developmental delay, dyslexia, or any health problem interfering with eating habits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEaters Choice ModuleThere will be nine sessions conducted throughout the intervention period, which include module activity, assessment sessions and follow-up sessions. This module will have four primary sub modules (SM): SM1- An overview of picky eaters, SM2-Healthy eating for children, SM3-Parental Strategies and SM4- Sensory perception. | Behavioural | Module PEaters Choice™ |
Primary outcome
Change of food repertoire from baseline at sixth weeks
Time frame: The list will be collected at the sixth weeks.
List of food eaten by the subject
Change of food repertoire from baseline at 12th weeks
Time frame: The list will be collected the 12th weeks.
List of food eaten by the subject
10 secondary outcomes
Change of children's eating behaviors (CEBQ) from baseline at sixth weeks
Time frame: It will be collected at the sixth weeks
Change of children's eating behaviors (CEBQ) from baseline at 12th weeks
Time frame: It will be collected at the 12th weeks
Change of weight-for-age (z-scores) from baseline at sixth weeks
Time frame: It will be collected at the sixth weeks
Change of weight-for-age (z-scores) from baseline at 12th weeks
Time frame: It will be collected at the 12th weeks
Change of height-for-age (z-scores) from baseline at sixth weeks
Time frame: It will be collected at the sixth weeks
Change of height-for-age (z-scores) from baseline at 12th weeks
Time frame: It will be collected at the 12th weeks
Change of weight-for-height (z-scores) from baseline at sixth weeks
Time frame: It will be collected at the sixth weeks
Change of weight-for-height (z-scores) from baseline at 12th weeks
Time frame: It will be collected at the 12th weeks
Change of BMI-for-age (z-scores) from baseline at sixth weeks
Time frame: It will be collected at the sixth weeks
Change of BMI-for-age (z-scores) from baseline at 12th weeks
Time frame: It will be collected at the 12th weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Background: PubMed 22816553Goh DY, Jacob A. Perception of picky eating among children in Singapore and its impact on caregivers: a questionnaire survey. Asia Pac Fam Med. 2012 Jul 20;11(1):5. doi: 10.1186/1447-056X-11-5.
- Background: PubMed 27825943Li Z, van der Horst K, Edelson-Fries LR, Yu K, You L, Zhang Y, Vinyes-Pares G, Wang P, Ma D, Yang X, Qin L, Wang J. Perceptions of food intake and weight status among parents of picky eating infants and toddlers in China: A cross-sectional study. Appetite. 2017 Jan 1;108:456-463. doi: 10.1016/j.appet.2016.11.009. Epub 2016 Nov 4.
- Background: PubMed 27077700Machado BC, Dias P, Lima VS, Campos J, Goncalves S. Prevalence and correlates of picky eating in preschool-aged children: A population-based study. Eat Behav. 2016 Aug;22:16-21. doi: 10.1016/j.eatbeh.2016.03.035. Epub 2016 Apr 5.
- BackgroundMohd Hanapi, H. & Mohd Fahmi Teng, N. I. 2022. Picky Eating Behaviour and Nutritional Status of Preschool Children in Kuala Selangor, Malaysia. Mal J Med Health Sci 18(1): 145-150.
- Individual participant dataSharing planned: No. Only the research team and the Research Ethics Committee (REC), UKM can access this data. Data will be reported collectively without reference to individuals. Therefore subject identity and personal data will be kept confidential.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nur Hana Hamzaid principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEaters Choice Module in people with Picky Eating, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nur Hana Hamzaid (+03-9289 7511 ext. 7080, hanahamzaid@ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of food repertoire from baseline at sixth weeks (time frame: The list will be collected at the sixth weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05445193, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.