Body Weight Clinical Trial
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.
NCT number | NCT05486403 |
Other study ID # | 2020-169 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 18, 2022 |
Est. completion date | January 31, 2023 |
Verified date | August 2023 |
Source | Singapore Institute for Clinical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 205 |
Est. completion date | January 31, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 6 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Singapore | Singapore Institute for Clinical Sciences | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore Institute for Clinical Sciences | National University of Singapore |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Child appetite traits | 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) | |
Primary | 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) | |
Primary | 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 | 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). | Baseline and Post-intervention (~6 weeks) | |
Secondary | 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) . | Post-intervention (~6 weeks) | |
Secondary | 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. | During the intervention (~ week 1, 2, 3, 4, 5, and 6 of the Appetite Toolbox programme) |
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