NCT03926065

Brief Summary

The aim of the study is to determine the effect of varying both the palatability and portion size of vegetables served to preschool children at a meal on the outcomes of food and energy intake at the meal.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 28, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 4, 2020

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

April 19, 2019

Results QC Date

August 18, 2020

Last Update Submit

September 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference Between Interventions in Vegetable Intake

    Weight of vegetables consumed at the meal (grams)

    One meal per week for each intervention (Study weeks 1, 2, 3, and 4)

Secondary Outcomes (3)

  • Difference Between Interventions in Food Intake

    One meal per week for each intervention (Study weeks 1, 2, 3, and 4)

  • Difference Between Interventions in Meal Energy Intake

    One meal per week for each intervention (Study weeks 1, 2, 3, and 4)

  • Difference Between Interventions in Meal Energy Density

    One meal per week for each intervention (Study weeks 1, 2, 3, and 4)

Other Outcomes (3)

  • Preference of Vegetables Served at the Meal

    Study week 5

  • Liking of All Foods Served at the Meal

    Study week 5

  • Ranking of All Foods Served at the Meal

    Study week 5

Study Arms (4)

Standard Palatability and Standard Portion Size

EXPERIMENTAL

Vegetables with Standard Palatability and Standard Portion Size

Other: Plain Vegetables Served in 100% Portion Size

Standard Palatability and Larger Portion Size

EXPERIMENTAL

Vegetables with Standard Palatability and Larger Portion Size

Other: Plain Vegetables Served in 200% Portion Size

Enhanced Palatability and Standard Portion Size

EXPERIMENTAL

Vegetables with Enhanced Palatability and Standard Portion Size

Other: Enhanced Vegetables Served in 100% Portion Size

Enhanced Palatability and Larger Portion Size

EXPERIMENTAL

Vegetables with Enhanced Palatability and Larger Portion Size

Other: Enhanced Vegetables Served in 200% Portion Size

Interventions

Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables

Standard Palatability and Standard Portion Size

Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables

Standard Palatability and Larger Portion Size

Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables

Enhanced Palatability and Standard Portion Size

Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables

Enhanced Palatability and Larger Portion Size

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children who are enrolled in a scheduled classroom of the designated childcare centers

You may not qualify if:

  • Children who are allergic to any of the foods served
  • Children whose diets exclude any of the foods served
  • Children who will not be present at the childcare center for all of the scheduled study days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

  • Diktas HE, Roe LS, Keller KL, Sanchez CE, Rolls BJ. Promoting vegetable intake in preschool children: Independent and combined effects of portion size and flavor enhancement. Appetite. 2021 Sep 1;164:105250. doi: 10.1016/j.appet.2021.105250. Epub 2021 Apr 6.

MeSH Terms

Conditions

Feeding Behavior

Interventions

Portion Size

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Results Point of Contact

Title
Dr. Barbara J. Rolls
Organization
Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition and Director of the Laboratory for the Study Human Ingestive Behavior

Study Record Dates

First Submitted

April 19, 2019

First Posted

April 24, 2019

Study Start

May 28, 2019

Primary Completion

October 24, 2019

Study Completion

October 29, 2019

Last Updated

September 25, 2020

Results First Posted

September 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations