- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06137677
Child Sweet and Savory Snack Study
January 15, 2025 updated by: Barbara J. Rolls, Penn State University
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
University Park, Pennsylvania, United States, 16802
- The Pennsylvania State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sweet Snack
A sweet food will be served as the snack
|
A sweet food will be served for the snack
|
|
Experimental: Savory Snack
A savory food will be served as the snack
|
A savory food will be served for the snack
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change between interventions in liking of each test food
Time Frame: Study weeks 1 and 2
|
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
Time Frame: Study weeks 1 and 2
|
Change in ranked preference (before to after consumption) of the 5 test foods.
|
Study weeks 1 and 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change between interventions of intake by weight
Time Frame: Study weeks 1 and 2
|
Weight (grams) of food and water consumed
|
Study weeks 1 and 2
|
|
Change between interventions of intake by energy
Time Frame: Study weeks 1 and 2
|
Energy (kilocalories) of food consumed
|
Study weeks 1 and 2
|
|
Change between interventions in fullness ratings from before to after consumption
Time Frame: Study weeks 1 and 2
|
Change in fullness ratings (before to after consumption) measured using a 4-point scale ranging from empty to full.
|
Study weeks 1 and 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2024
Primary Completion (Actual)
May 15, 2024
Study Completion (Actual)
May 15, 2024
Study Registration Dates
First Submitted
November 14, 2023
First Submitted That Met QC Criteria
November 14, 2023
First Posted (Actual)
November 18, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 15, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- ChildFood701
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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