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Variations in Palatability and Portion Size of Vegetables on Meal Intake of Preschool Children

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ClinicalTrials.gov Identifier: NCT03926065
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : June 4, 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 palatability and portion size of vegetables 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: Plain Vegetables Served in 100% Portion Size Other: Plain Vegetables Served in 200% Portion Size Other: Enhanced Vegetables Served in 100% Portion Size Other: Enhanced Vegetables Served in 200% Portion Size Not Applicable

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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: Lunchtime Meal Feeding Study for Preschool Children
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

Arm Intervention/treatment
Experimental: Standard Palatability and Standard Portion Size
Vegetables with Standard Palatability and Standard Portion Size
Other: Plain Vegetables Served in 100% Portion Size
Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables

Experimental: Standard Palatability and Larger Portion Size
Vegetables with Standard Palatability and Larger Portion Size
Other: Plain Vegetables Served in 200% Portion Size
Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables

Experimental: Enhanced Palatability and Standard Portion Size
Vegetables with Enhanced Palatability and Standard Portion Size
Other: Enhanced Vegetables Served in 100% Portion Size
Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables

Experimental: Enhanced Palatability and Larger Portion Size
Vegetables with Enhanced Palatability and Larger Portion Size
Other: Enhanced Vegetables Served in 200% Portion Size
Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables




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


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

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

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


Other Outcome Measures:
  1. Preference of vegetables served at the meal [ Time Frame: Study week 5 ]
    Preferred version of vegetables (1=standard palatability, 2=enhanced palatability)

  2. Liking of all foods served at the meal [ Time Frame: Study week 5 ]
    The Yummy-Yucky Cartoon Faces Scale (1=Yucky, 2=Just Okay, and 3=Yummy)

  3. Ranking of all foods served at the meal [ Time Frame: Study week 5 ]
    Ranking of all foods in order of preference (1= most preferred, 2= next most preferred, etc.)



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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): NCT03926065


Contacts
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Contact: Christine Sanchez 814-863-8481 cqv5011@psu.edu

Locations
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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)

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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: NCT03926065     History of Changes
Other Study ID Numbers: ChildFood402
R01DK082580 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No