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Completed

NCT Number: NCT05486403

The Appetite Toolbox for Preschools

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.

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Key information

Conditions

Eating Behavior Behavior Behavior, Animal Body Weight Feeding Behavior Pathological Conditions, Signs and Symptoms Self Regulation Self-Control Signs and Symptoms Social Behavior

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore Institute for Clinical Sciences

Singapore, 117609

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Appetite Toolbox Programme

Behavioral

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 outcomes

  1. Child appetite awareness

    Time frame: Baseline and Post-intervention (~6 weeks)

    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".

  2. Child eating in the absence of hunger (EAH)

    Time frame: Baseline and Post-intervention (~6 weeks)

    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 outcomes

  1. Implementation outcomes (quantitative)

    Time frame: Baseline and Post-intervention (~6 weeks)

    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).

  2. Implementation outcomes (qualitative)

    Time frame: Post-intervention (~6 weeks)

    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) .

  3. Appetite Toolbox Fidelity

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

    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.

Other outcomes

  1. Child appetite traits

    Time frame: Baseline and Post-intervention (~6 weeks)

    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).

Sponsors and collaborators

Lead sponsor

Institute for Human Development and Potential (IHDP), Singapore

Other

Collaborators

  • National University of Singapore

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 3, 2022
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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