PEaters Choice™: Nutrition Intervention Module for Picky Eaters

NCT05445193 | Unknown

• 1 other identifier: PEatersChoice_NUMas
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Picky Eating

Keywords

picky eaters; food repertoire; children eating behaviour; nutrition intervention module

Outcome Measures

Primary Outcomes (2)

• Change of food repertoire from baseline at sixth weeks

  List of food eaten by the subject

  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

  The list will be collected the 12th weeks.

Secondary Outcomes (10)

• Change of children's eating behaviors (CEBQ) from baseline at sixth weeks

  It will be collected at the sixth weeks

• Change of children's eating behaviors (CEBQ) from baseline at 12th weeks

  It will be collected at the 12th weeks

• Change of weight-for-age (z-scores) from baseline at sixth weeks

  It will be collected at the sixth weeks

• Change of weight-for-age (z-scores) from baseline at 12th weeks

  It will be collected at the 12th weeks

• Change of height-for-age (z-scores) from baseline at sixth weeks

  It will be collected at the sixth weeks

Study Arms (2)

Module PEaters Choice™

EXPERIMENTAL

Using module that will be develop

Behavioral: PEaters Choice Module

Standard nutrition information

NO INTERVENTION

No intervention done, just a standard information about nutrition.

Interventions

PEaters Choice Module BEHAVIORAL

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.

Module PEaters Choice™

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects are between three and five years old
• Subjects had PE problems (screened using the CEBQ)

You may not qualify if:

• subject has clinical health problems such as autism, down syndrome, global developmental delay, dyslexia, or any health problem interfering with eating habits.

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

UKM Specialist Children's Hospital

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (4)

• 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.

  PMID: 22816553 BACKGROUND

• Li 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.

  PMID: 27825943 BACKGROUND

• Machado 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.

  PMID: 27077700 BACKGROUND

• Mohd 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.

  BACKGROUND

MeSH Terms

Conditions

Food Fussiness

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Nur Hana Hamzaid

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nur Hana Hamzaid

CONTACT

+03-9289 7511; hanahamzaid@ukm.edu.my

Mohd Shah Kamarudin

CONTACT

+60123965367; mohdshahkamarudin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 6, 2022
• Study Start: March 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: February 1, 2025
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)