- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06427837
Child Snack Variety Study
May 20, 2024 updated by: Barbara J. Rolls, Penn State University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
50
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 Contact
- Name: Cara Meehan
- Phone Number: 814-863-8481
- Email: cmt5070@psu.edu
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 participating childcare center
- Children who are between the ages of 6 and 14 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 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.)
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: Same 2nd course
The same snack food will be served in the second course
|
The same snack food will be served in the second course
|
Experimental: Different 2nd course
A different snack food will be served in the second course
|
A different snack food will be served in the second course
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change between interventions of snack 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 snack intake by energy
Time Frame: Study weeks 1 and 2
|
Energy (kcal) of food consumed
|
Study weeks 1 and 2
|
Secondary 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
|
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 (Estimated)
June 10, 2024
Primary Completion (Estimated)
September 20, 2024
Study Completion (Estimated)
September 27, 2024
Study Registration Dates
First Submitted
May 20, 2024
First Submitted That Met QC Criteria
May 20, 2024
First Posted (Actual)
May 24, 2024
Study Record Updates
Last Update Posted (Actual)
May 24, 2024
Last Update Submitted That Met QC Criteria
May 20, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- ChildFood802
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
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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