Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Varying Portion Size and Palatability on Food Intake of Preschool Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03643250
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Barbara J. Rolls, Penn State University

Brief Summary:
The aim of the study is to determine the effect of varying both the portion size and the appeal (palatability and presentation) of foods served to preschool children at a meal on the outcomes of food and energy intake at the meal.

Condition or disease Intervention/treatment Phase
Feeding Behavior Other: Smaller Portion Size and Standard Appeal (non-divided plate) Other: Smaller Portion Size and Enhanced Appeal (divided plate) Other: Larger Portion Size and Standard Appeal (non-divided plate) Other: Larger Portion Size and Enhanced Appeal (divided plate) Other: Smaller Portion Size and Standard Appeal (divided plate) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: Lunch Feeding Study for Preschool Children
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

Arm Intervention/treatment
Experimental: Smaller Portion Size and Standard Appeal (non-divided plate)
Food with Smaller Portion Size and Standard Appeal on a non-divided plate
Other: Smaller Portion Size and Standard Appeal (non-divided plate)
Food with Smaller Portion Size and Standard Appeal on a non-divided plate

Experimental: Smaller Portion Size and Enhanced Appeal (divided plate)
Food with Smaller Portion Size and Enhanced Appeal on a divided plate
Other: Smaller Portion Size and Enhanced Appeal (divided plate)
Food with Smaller Portion Size and Enhanced Appeal on a divided plate

Experimental: Larger Portion Size and Standard Appeal (non-divided plate)
Food with Larger Portion Size and Standard Appeal on a non-divided plate
Other: Larger Portion Size and Standard Appeal (non-divided plate)
Food with Larger Portion Size and Standard Appeal on a non-divided plate

Experimental: Larger Portion Size and Enhanced Appeal (divided plate)
Food with Larger Portion Size and Enhanced Appeal on a divided plate
Other: Larger Portion Size and Enhanced Appeal (divided plate)
Food with Larger Portion Size and Enhanced Appeal on a divided plate

Experimental: Smaller Portion Size and Standard Appeal (divided plate)
Food with Smaller Portion Size and Standard Appeal on a divided plate
Other: Smaller Portion Size and Standard Appeal (divided plate)
Food with Smaller Portion Size and Standard Appeal on a divided plate




Primary Outcome Measures :
  1. Difference between interventions in meal energy intake [ Time Frame: Study weeks 1, 2, 3, 4, and 5 ]
    Energy consumed at the meal (kcal)


Secondary Outcome Measures :
  1. Difference between interventions in food intake [ Time Frame: Study weeks 1, 2, 3, 4, and 5 ]
    Weight of food consumed at the meal (g)

  2. Difference between interventions in meal energy density [ Time Frame: Study weeks 1, 2, 3, 4, and 5 ]
    Energy density of the food consumed at the meal (kcal/g)


Other Outcome Measures:
  1. Liking of food served at the meal [ Time Frame: Study week 6 ]
    The Yummy-Yucky Cartoon Faces Scale (1=Yucky, 2=Just Okay, and 3=Yummy)

  2. Preference of plate and vegetables served at the meal [ Time Frame: Study week 6 ]
    Preferred version of plate (1=non-divided plate, 2=divided plate), broccoli (1=standard appeal, 2=enhanced appeal), and corn (1=standard appeal, 2=enhanced appeal) of the two versions presented



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643250


Contacts
Layout table for location contacts
Contact: Christine Sanchez 814-863-8481 cqv5011@psu.edu

Locations
Layout table for location information
United States, Pennsylvania
Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University Recruiting
University Park, Pennsylvania, United States, 16802
Contact: Christine Sanchez    814-863-8481    cqv5011@psu.edu   
Sponsors and Collaborators
Penn State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Layout table for additonal information
Responsible Party: Barbara J. Rolls, Professor of Nutrition and Director of the Laboratory for the Study Human Ingestive Behavior, Penn State University
ClinicalTrials.gov Identifier: NCT03643250     History of Changes
Other Study ID Numbers: ChildFood401
R01DK082580 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No