## Protocol Section
### Identification Module
**NCT ID:** NCT06427837

**Brief Title:** Child Snack Variety Study

**Official Title:** Child Snack Variety Study

#### Organization Study ID Info
**ID:** ChildFood802
#### Organization
**Class:** OTHER
**Full Name:** Penn State University
### Status Module
#### Completion Date
**Date:** 2024-09-27

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-20

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Penn State University

#### Responsible Party

**Investigator Affiliation:** Penn State University

**Investigator Full Name:** Barbara J. Rolls

**Investigator Title:** Professor of Nutritional Sciences

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Eating Behavior

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The same snack food will be served in the second course

**Intervention Names:**

- Other: Same 2nd course

**Label:** Same 2nd course

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** A different snack food will be served in the second course

**Intervention Names:**

- Other: Different 2nd course

**Label:** Different 2nd course

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Same 2nd course

**Description:** The same snack food will be served in the second course

**Name:** Same 2nd course

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Different 2nd course

**Description:** A different snack food will be served in the second course

**Name:** Different 2nd course

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Weight (grams) of food and water consumed

**Measure:** Change between interventions of snack intake by weight

**Time Frame:** Study weeks 1 and 2

**Description:** Energy (kcal) of food consumed

**Measure:** Change between interventions of snack intake by energy

**Time Frame:** Study weeks 1 and 2

#### Secondary Outcomes

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

**Measure:** Change between interventions in liking of each test food

**Time Frame:** Study weeks 1 and 2

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

**Measure:** Change between interventions in ranked preference of each test food from before to after consumption

**Time Frame:** Study weeks 1 and 2

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

**Measure:** Change between interventions in fullness ratings from before to after consumption

**Time Frame:** Study weeks 1 and 2

### Eligibility Module

**Eligibility Criteria:** 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.)

**Healthy Volunteers:** True

**Maximum Age:** 14 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cmt5070@psu.edu

**Name:** Cara Meehan

**Phone:** 814-863-8481

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
