NCT05486403

Brief Summary

This study uses a Hybrid research design to assess the effectiveness and implementation of a preschool-based programme - the Appetite Toolbox - delivered by Early Childhood Educators to promote children's appetite awareness and eating regulation skills. Children, their caregivers and classroom teachers will be recruited across 18 classrooms from preschool childcare centers. Preschool educators will deliver the Appetite Toolbox over a period of six weeks. Using a waitlist-control design we will measure changes in children's appetite awareness and eating regulation skills in school and describe implementation outcomes, such as fidelity, acceptability, and feasibility of the programme.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

August 1, 2022

Last Update Submit

August 18, 2023

Conditions

Keywords

Hybrid DesignPreschoolEating BehaviourAppetiteEating RegulationFood intake

Outcome Measures

Primary Outcomes (2)

  • Child appetite awareness

    Difference in accuracy in identifying changes in hunger and fullness pre- and post- meal for i) self (measured at lunch time), and ii) a fictional character described in a story. Ratings will be made on a custom 5-point picture rating scale ranging from "very hungry, my tummy is empty" (1) to "Very full, there is no room left in my tummy".

    Baseline and Post-intervention (~6 weeks)

  • Child eating in the absence of hunger (EAH)

    Differences in the tendency for children to 'eat in the absence of hunger' (EAH) pre- and post-intervention. EAH is measured as the total calories consumed from a snack immediately presented within 10 minutes after consuming lunch, where more calories consumed confers greater EAH.

    Baseline and Post-intervention (~6 weeks)

Secondary Outcomes (3)

  • Implementation outcomes (quantitative)

    Baseline and Post-intervention (~6 weeks)

  • Implementation outcomes (qualitative)

    Post-intervention (~6 weeks)

  • Appetite Toolbox Fidelity

    During the intervention (~ week 1, 2, 3, 4, 5, and 6 of the Appetite Toolbox programme)

Other Outcomes (1)

  • Child appetite traits

    Baseline and Post-intervention (~6 weeks)

Study Arms (2)

Intervention

EXPERIMENTAL

Preschool Educators deliver the Appetite Toolbox programme directly to children over a period of six weeks after the pre-test and before the post-test effectiveness measures.

Behavioral: Appetite Toolbox Programme

Waitlist Control

OTHER

Preschool Educators continue to deliver their usual preschool curriculum over a period of six weeks after the pre-test and before the post-test effectiveness measures. They will deliver the Appetite Toolbox programme directly to children after the post-test measures.

Behavioral: Appetite Toolbox Programme

Interventions

Preschool educators are trained to deliver a bio-behavioural classroom-based programme focusing on building skills in i) appetite awareness, ii) attention/attention control and iii) sensing body cues. The programme is delivered using a combination of interactive story books, classroom props and activities, and mealtime transitions/routines.

InterventionWaitlist Control

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children:
  • Age 3 years 0 months to 6 years 11 months.
  • English speaker (primary or secondary language)
  • Enrolled in the childcare Program of the participating school
  • Parent/Legal guardian/Caregiver:
  • Age 21 years and older
  • English speaker (primary or secondary language)
  • Staff:
  • Age 21 years and older
  • English speaker (primary or secondary language)
  • Currently employed as teaching staff at a participating preschool

You may not qualify if:

  • Children:
  • Severe food allergy
  • Does not normally eat the school's meal and snack provisions
  • Non-English speaker (English is not primary or secondary language)
  • A medical condition affecting appetite and metabolism
  • Parent/Legal guardian/Caregiver:
  • Below 21 years old
  • A non-English speaker (English is not primary or secondary language)
  • Staff:
  • Below 21 years old
  • A non-English speaker (English is not primary or secondary language)
  • Not employed as teaching staff at a participating preschool

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Institute for Clinical Sciences

Singapore, 117609, Singapore

Location

MeSH Terms

Conditions

Feeding BehaviorSelf-ControlBody Weight

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorSocial BehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The effectiveness measures are assessed using a parallel cluster-controlled design. The preschool center is considered a cluster for randomisation to either an Intervention Group or Waitlist Control Group. All preschool centers will deliver the Appetite Toolbox programme by the end of the research and contribute to the implementation outcomes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 3, 2022

Study Start

July 18, 2022

Primary Completion

December 1, 2022

Study Completion

January 31, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Locations