Clinical trial NCT05486403: 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
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behavior
Self Regulation
Body Weight
Keywords: Hybrid Design
Preschool
Eating Behaviour
Appetite
Eating Regulation
Food intake
Lead sponsor: Institute for Human Development and Potential (IHDP), Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2022-08-03
Enrollment: 205
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Child appetite awareness
timeFrame: Baseline and Post-intervention (~6 weeks)
measure: Child eating in the absence of hunger (EAH)
timeFrame: Baseline and Post-intervention (~6 weeks)
Secondary outcomes:
measure: Implementation outcomes (quantitative)
timeFrame: Baseline and Post-intervention (~6 weeks)
measure: Implementation outcomes (qualitative)
timeFrame: Post-intervention (~6 weeks)
measure: Appetite Toolbox Fidelity
timeFrame: During the intervention (~ week 1, 2, 3, 4, 5, and 6 of the Appetite Toolbox programme)
Other outcomes:
measure: Child appetite traits
timeFrame: Baseline and Post-intervention (~6 weeks)
Locations:
city: Singapore
country: Singapore
facility: Singapore Institute for Clinical Sciences
Study officials:
References: