Child Sweet and Savory Snack Study

• Sponsor: Penn State University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06137677
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9.5
• Patients Per Site Per Month: 7.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eating Behavior	Other: Sweet Snack; Other: Savory Snack	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Child Sweet and Savory Snack Study
• Anticipated Study Start Date: Jan 22, 2024
• Anticipated Primary Completion Date: Oct 30, 2024
• Anticipated Study Completion Date: Nov 7, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sweet Snack A sweet food will be served as the snack	Other: Sweet Snack; A sweet food will be served for the snack
Experimental: Savory Snack A savory food will be served as the snack	Other: Savory Snack; A savory food will be served for the snack

Outcome Measures

Primary Outcome Measures

1. Change between interventions in liking of each test food [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).

2. Change between interventions in ranked preference of each test food from before to after consumption [Study weeks 1 and 2]

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

Secondary Outcome Measures

1. Change between interventions of intake by weight [Study weeks 1 and 2]

   Weight (grams) of food and water consumed

2. Change between interventions of intake by energy [Study weeks 1 and 2]

   Energy (kilocalories) of food consumed

3. Change between interventions in fullness ratings from before to after consumption [Study weeks 1 and 2]

   Change in fullness ratings (before to after consumption) measured using a 4-point scale ranging from empty to full.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Pennsylvania State University	University Park	Pennsylvania	United States	16802

Sponsors and Collaborators

• Penn State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Barbara J. Rolls, Professor of Nutritional Sciences, Penn State University
• ClinicalTrials.gov Identifier: NCT06137677
• Other Study ID Numbers: ChildFood701
• First Posted: Nov 18, 2023
• Last Update Posted: Nov 18, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 18, 2023