- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05486403
The Appetite Toolbox for Preschools
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 117609
- Singapore Institute for Clinical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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 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.
|
Other: Waitlist Control
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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".
|
Baseline and Post-intervention (~6 weeks)
|
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.
|
Baseline and Post-intervention (~6 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline and Post-intervention (~6 weeks)
|
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) .
|
Post-intervention (~6 weeks)
|
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.
|
During the intervention (~ week 1, 2, 3, 4, 5, and 6 of the Appetite Toolbox programme)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline and Post-intervention (~6 weeks)
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-169
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Body Weight
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)RecruitingWeight Loss | Weight, BodyUnited States
-
Oslo University HospitalMayo Clinic; Sorlandet Hospital HF; The Hospital of Vestfold; University of TwenteActive, not recruiting
-
Fred Hutchinson Cancer CenterCompletedWeight Loss | Weight, BodyUnited States
-
Pusan National University HospitalCompletedWeight Change, Body
-
Erik Ramirez LopezCompletedWeight Loss | Body CompositionMexico
-
Xinhua Hospital, Shanghai Jiao Tong University...Not yet recruiting
-
University of TennesseeMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases...CompletedSmoking Cessation | Weight Change, BodyUnited States
-
University of LeedsDietary Assessment LtdRecruitingWeight Loss | Colorectal Surgery | Weight Change, Body | Gastroenterology SurgeryUnited Kingdom
-
Virta HealthCompleted
-
University of CopenhagenCompleted
Clinical Trials on Appetite Toolbox Programme
-
Nova Scotia Health AuthorityDalhousie University; Horizon Health Network; Canadian Frailty NetworkCompletedPrimary Health Care | Polypharmacy | Inappropriate PrescribingCanada
-
Academisch Medisch Centrum - Universiteit van Amsterdam...National Intensive Care Evaluation FoundationCompletedPain Management | Critical Care | Quality ImprovementNetherlands
-
Ethicon Endo-SurgeryCompleted
-
University of PennsylvaniaUniversity of BathNot yet recruitingDepression | Anxiety | Happiness
-
University of PennsylvaniaWithdrawnAnxiety | Depressive Symptoms | Happiness
-
University of PennsylvaniaAshoka University; Jindal Global UniversityCompletedAnxiety | Depressive Symptoms | HappinessIndia
-
Washington University School of MedicineRecruitingCentral Nervous SystemUnited States
-
Emory UniversityNational Institute on Aging (NIA)Completed
-
Milton S. Hershey Medical CenterCompletedColorectal Cancer ScreeningUnited States
-
University of PennsylvaniaOhio State University; Indiana University; University of Missouri, St. LouisRecruiting