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The Appetite Toolbox for Preschools

Primary Purpose

Eating Behavior, Self Regulation, Body Weight

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Appetite Toolbox Programme
Sponsored by
Singapore Institute for Clinical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eating Behavior focused on measuring Hybrid Design, Preschool, Eating Behaviour, Appetite, Eating Regulation, Food intake

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Singapore Institute for Clinical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Waitlist Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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".
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.

Secondary Outcome Measures

Implementation outcomes (quantitative)
Educator reported measures of appropriateness, acceptability and feasibility of the Appetite Toolbox programme, utility of the training and self-efficacy and intention to continue using the Appetite Toolbox resources. The implementation outcomes will be assessed using validated scales from Weiner and colleagues, with additional measures guided by the Consolidated Framework for Implementation Research (CFIR).
Implementation outcomes (qualitative)
A series of focus-group discussions will be held to capture further information on the implementation of the Appetite Toolbox programme. The focus group guides and subsequent coding will be guided by constructs outlined in the CFIR, including characteristics of the Appetite Toolbox programme (e.g. adaptability, perceived complexity), the preschool staff (e.g. knowledge, beliefs, self-efficacy) and organisational settings (e.g. learning climate, goals, priorities) .
Appetite Toolbox Fidelity
Educator fidelity to the Appetite Toolbox programme will be estimated using educator log-books and a classroom observation made by the research team, to characterise the use and delivery of the programme and meal transitions across classrooms.

Full Information

First Posted
August 1, 2022
Last Updated
August 18, 2023
Sponsor
Singapore Institute for Clinical Sciences
Collaborators
National University of Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT05486403
Brief Title
The Appetite Toolbox for Preschools
Official Title
The Appetite Toolbox: A Hybrid Type I Pilot Trial Testing the Effectiveness and Initial Implementation of a Programme Designed to Promote Children's Eating Regulation Skills in Preschool.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Singapore Institute for Clinical Sciences
Collaborators
National University of Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The Appetite Toolbox is a programme developed for use in preschools and designed to promote children's appetite awareness and eating regulation skills through a series of books, classroom activities and mealtime routines developed with curriculum specialists and aligned to the Centre's core curriculum competencies (e.g. Language and Literacy, and Social and Emotional Development). Using a Hybrid Type I cluster-controlled pilot design, the Appetite Toolbox for preschools study aims to: i) Characterise the effectiveness of the Appetite Toolbox delivered over to increase children's awareness of appetite and eating regulation skills over a six-week period. ii) Assess implementation of the Appetite Toolbox in preschool centers, with a focus on acceptability, appropriateness, fidelity, and feasibility of Appetite Toolbox as delivered by preschool educators. The research team will also explore whether differences in home feeding practices and implementation factors moderated the effectiveness of the Appetite Toolbox in preschools. Children will be recruited from N2, K1 and K2 classrooms across six preschools from the same anchor operator and three locations (18 classrooms in total, three per school). At each location, preschools will be randomised to complete the Appetite Toolbox programme over a period of six weeks, either immediately (intervention group) or later in the school year (waitlist-control group). Effectiveness will be characterised by changes in children's ability to communicate meaningful changes in appetite, portion selections and tendency to snack in the absence of hunger. While implementation measures will assess the utility of training provisions alongside fidelity, acceptability, and appropriateness of the Appetite Toolbox programme in both the intervention and waitlist schools, captured through a series of questionnaires, in-class observations and interviews with teaching staff, central curriculum leaders and specialists. The research results will provide important evidence for the impact and application of the Appetite Toolbox materials as a low-cost means to improve childhood eating behaviours via preschools and early years education, and inform the design of a larger-scale definitive trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Behavior, Self Regulation, Body Weight
Keywords
Hybrid Design, Preschool, Eating Behaviour, Appetite, Eating Regulation, Food intake

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Appetite Toolbox Programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child appetite awareness
Description
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".
Time Frame
Baseline and Post-intervention (~6 weeks)
Title
Child eating in the absence of hunger (EAH)
Description
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.
Time Frame
Baseline and Post-intervention (~6 weeks)
Secondary Outcome Measure Information:
Title
Implementation outcomes (quantitative)
Description
Educator reported measures of appropriateness, acceptability and feasibility of the Appetite Toolbox programme, utility of the training and self-efficacy and intention to continue using the Appetite Toolbox resources. The implementation outcomes will be assessed using validated scales from Weiner and colleagues, with additional measures guided by the Consolidated Framework for Implementation Research (CFIR).
Time Frame
Baseline and Post-intervention (~6 weeks)
Title
Implementation outcomes (qualitative)
Description
A series of focus-group discussions will be held to capture further information on the implementation of the Appetite Toolbox programme. The focus group guides and subsequent coding will be guided by constructs outlined in the CFIR, including characteristics of the Appetite Toolbox programme (e.g. adaptability, perceived complexity), the preschool staff (e.g. knowledge, beliefs, self-efficacy) and organisational settings (e.g. learning climate, goals, priorities) .
Time Frame
Post-intervention (~6 weeks)
Title
Appetite Toolbox Fidelity
Description
Educator fidelity to the Appetite Toolbox programme will be estimated using educator log-books and a classroom observation made by the research team, to characterise the use and delivery of the programme and meal transitions across classrooms.
Time Frame
During the intervention (~ week 1, 2, 3, 4, 5, and 6 of the Appetite Toolbox programme)
Other Pre-specified Outcome Measures:
Title
Child appetite traits
Description
Caregiver (home) reported child appetite traits, such as satiety responsivity, emotional overeating and slowness in eating, assessed using the Children's Eating Behaviour Questionnaire (CEBQ).
Time Frame
Baseline and Post-intervention (~6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Singapore Institute for Clinical Sciences
City
Singapore
ZIP/Postal Code
117609
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
De-identified data will be made available upon reasonable request for research purposes, pending relevant approvals from the Institutional Review Board(s) and preschool organisation.

Learn more about this trial

The Appetite Toolbox for Preschools

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