search
Back to results

Children's Taste Study to Increase Vegetable Intake in Preschoolers (CTS)

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Variety Intervention
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring Eating Behaviors, Preschool, Vegetable Intake

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Acceptance of test meal foods
  • Generally healthy

Exclusion Criteria:

  • Food allergies
  • Medications (prescription or OTC) that can affect taste, smell or appetite
  • Medical conditions

Sites / Locations

  • The Pennsylvania State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Variety

No Variety - Control

Arm Description

Children receive three servings of vegetables each prepared with a different herb and spice blend.

Children receive three servings of vegetables each prepared with the same herb and spice blend.

Outcomes

Primary Outcome Measures

Chang in Vegetable Intake
Consumption is measured by pre- and post- weights of carrot offered in both the variety and no variety conditions
Change in Total Food Intake
Consumption is measured by pre- and post- weights of all meal items offered in both the variety and no variety conditions
Change in Meal Energy Density
Calculated from the total calories consumed divided by the grams of food eaten

Secondary Outcome Measures

Spice Intake Questionnaire
A survey of maternally reported herb and spice consumption during pregnancy and breastfeeding as well as current home use
Home Spice Checklist
A comprehensive checklist of 34 herbs and spices for parents to fill out at home to evaluate children's overall herb and spice exposure
Infant Feeding Practices
A survey of maternally reported feeding practices, include breastfeeding, formula feeding, and introduction to solid foods.
Liking of Broccoli with Herbs and Spices
Liking is measured using a child friendly 5-pt hedonic scale; pilot data for future studies looking to apply this technique to green vegetables
Liking of Carrots with Herb and Spice Blends
Liking is measured using a child friendly 5-pt hedonic scale

Full Information

First Posted
October 6, 2016
Last Updated
April 4, 2022
Sponsor
Penn State University
search

1. Study Identification

Unique Protocol Identification Number
NCT03043118
Brief Title
Children's Taste Study to Increase Vegetable Intake in Preschoolers
Acronym
CTS
Official Title
A Pilot Study to Test the Influence of Vegetable Flavor Variety Using Herbs and Spices on Preschool Children's Vegetable Intake
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
November 2, 2016 (Actual)
Study Completion Date
November 2, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Studies have shown that when exposed to a variety of food and flavor options people tend to consume more than when only one item is presented. This strategy has been used to increase vegetable intake in adults and during snacktime in children. Increasing vegetable consumption in children is important because higher vegetable intake has been associated with reduced risk of disease and because vegetables can help prevent weight gain by lowering the energy density of a meal. The purpose of this study was to investigate the effects of using herb and spice blends to create flavor variety in carrots as a model vegetable in a laboratory test meal. We predict that children will consume more vegetables and that the energy density of the meal will be lower when a variety of seasoned carrots are presented in comparison to a single flavor. A secondary goal of the study was to determine other influences that may predict children's liking and intake of seasoned vegetables, such as previous exposure, infant feeding practices, and genetic bitter sensitivity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Eating Behaviors, Preschool, Vegetable Intake

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Variety
Arm Type
Experimental
Arm Description
Children receive three servings of vegetables each prepared with a different herb and spice blend.
Arm Title
No Variety - Control
Arm Type
No Intervention
Arm Description
Children receive three servings of vegetables each prepared with the same herb and spice blend.
Intervention Type
Other
Intervention Name(s)
Variety Intervention
Intervention Description
Vegetable flavor variety created with multiple herb and spice blends
Primary Outcome Measure Information:
Title
Chang in Vegetable Intake
Description
Consumption is measured by pre- and post- weights of carrot offered in both the variety and no variety conditions
Time Frame
Baseline and 1 week
Title
Change in Total Food Intake
Description
Consumption is measured by pre- and post- weights of all meal items offered in both the variety and no variety conditions
Time Frame
Baseline and 1 week
Title
Change in Meal Energy Density
Description
Calculated from the total calories consumed divided by the grams of food eaten
Time Frame
Baseline and 1 week
Secondary Outcome Measure Information:
Title
Spice Intake Questionnaire
Description
A survey of maternally reported herb and spice consumption during pregnancy and breastfeeding as well as current home use
Time Frame
Baseline
Title
Home Spice Checklist
Description
A comprehensive checklist of 34 herbs and spices for parents to fill out at home to evaluate children's overall herb and spice exposure
Time Frame
Baseline
Title
Infant Feeding Practices
Description
A survey of maternally reported feeding practices, include breastfeeding, formula feeding, and introduction to solid foods.
Time Frame
Baseline
Title
Liking of Broccoli with Herbs and Spices
Description
Liking is measured using a child friendly 5-pt hedonic scale; pilot data for future studies looking to apply this technique to green vegetables
Time Frame
Baseline
Title
Liking of Carrots with Herb and Spice Blends
Description
Liking is measured using a child friendly 5-pt hedonic scale
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
Age
Description
Age of the participant on visit 1
Time Frame
Baseline
Title
Height
Description
Height measured in cm on a stadiometer
Time Frame
Baseline
Title
Weight
Description
Weight measured to the 0.1 pounds using a digital scale
Time Frame
Baseline
Title
6-n-propylthiourcacil Sensitivity
Description
Children switch and spit a 56 umol solution of 6-n-propylthiouracil and are classified as tasters if it described as "bitter" or "yucky" and non-tasters if it's described as "nothing" or "like water".
Time Frame
Baseline
Title
Body Mass Index
Description
Calculated from height and weight (kg/m^2)
Time Frame
Baseline
Title
Children's Eating Behavior Questionnaire
Description
A validated parent-reported questionnaire on children's typical eating behaviors and attitudes toward foods
Time Frame
Baseline
Title
Preschool Adjusted Liking Scale
Description
A questionnaire to assess children's liking of various common foods and daily activities.
Time Frame
Baseline
Title
Family Demographics
Description
A parent-reported questionnaire
Time Frame
Baseline
Title
Parental Feeding Practices
Description
A parent-reported questionnaire on typical feeding practices
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Acceptance of test meal foods Generally healthy Exclusion Criteria: Food allergies Medications (prescription or OTC) that can affect taste, smell or appetite Medical conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen L Keller, Ph.D.
Organizational Affiliation
The Pennsylvania State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Children's Taste Study to Increase Vegetable Intake in Preschoolers

We'll reach out to this number within 24 hrs