NCT06137677

Brief Summary

The purpose of this study is to determine how consumption of a snack food affects the hedonic ratings of that snack food compared to other foods. The results will have implications for guidance about the provision of snacks for preschool children and may help in identifying strategies for the prevention of obesity in children.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 5, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

November 14, 2023

Last Update Submit

January 15, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change between interventions in liking of each test food

    Change between interventions in liking (before to after consumption) of the 5 test foods, measured using a visual analog scale (0-100 points).

    Study weeks 1 and 2

  • Change between interventions in ranked preference of each test food from before to after consumption

    Change in ranked preference (before to after consumption) of the 5 test foods.

    Study weeks 1 and 2

Secondary Outcomes (3)

  • Change between interventions of intake by weight

    Study weeks 1 and 2

  • Change between interventions of intake by energy

    Study weeks 1 and 2

  • Change between interventions in fullness ratings from before to after consumption

    Study weeks 1 and 2

Study Arms (2)

Sweet Snack

EXPERIMENTAL

A sweet food will be served as the snack

Other: Sweet Snack

Savory Snack

EXPERIMENTAL

A savory food will be served as the snack

Other: Savory Snack

Interventions

A sweet food will be served for the snack

Sweet Snack

A savory food will be served for the snack

Savory Snack

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children who are enrolled in a scheduled classroom of the participating childcare centers
  • Children who are between the ages of 4 and 6 years old at the time of enrollment

You may not qualify if:

  • Children who are allergic to any of the foods served
  • Children whose diets exclude any of the foods served
  • Children who are absent from the childcare center on the acclimation day or both study days
  • Children who are not able to complete study measures (e.g. only use the anchors or have low variability for their liking ratings)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutritional Sciences

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

February 5, 2024

Primary Completion

May 15, 2024

Study Completion

May 15, 2024

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations