NCT06427837

Brief Summary

The purpose of this study is to determine how consumption of a snack food at a first course affects the hedonic ratings of that snack food compared to other foods, and how it affects intake of a second course. 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

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

June 21, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2024

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

May 20, 2024

Last Update Submit

October 7, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change between interventions of snack intake by weight

    Weight (grams) of food and water consumed

    Study weeks 1 and 2

  • Change between interventions of snack intake by energy

    Energy (kcal) of food consumed

    Study weeks 1 and 2

Secondary Outcomes (3)

  • Change between interventions in liking of each test food

    Study weeks 1 and 2

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

    Study weeks 1 and 2

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

    Study weeks 1 and 2

Study Arms (2)

Same 2nd course

EXPERIMENTAL

The same snack food will be served in the second course

Other: Same 2nd course

Different 2nd course

EXPERIMENTAL

A different snack food will be served in the second course

Other: Different 2nd course

Interventions

The same snack food will be served in the second course

Same 2nd course

A different snack food will be served in the second course

Different 2nd course

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children who are enrolled in a participating childcare center
  • Children who are between the ages of 6 and 14 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 study days
  • Children who are not able to complete study measures (e.g. refuse to eat study foods, only use the anchors or have low variability for their liking ratings, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

311 Chandlee Laboratory

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

May 20, 2024

First Posted

May 24, 2024

Study Start

June 21, 2024

Primary Completion

August 16, 2024

Study Completion

August 16, 2024

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations