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

• Sponsor: Penn State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03926065
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 67
• Location: 1
• Arms: 4
• Actual Duration (Months): 5.1
• Patients Per Site Per Month: 13.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 67 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
• Actual Primary Completion Date: Oct 24, 2019
• Actual Study Completion Date: Oct 29, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Difference Between Interventions in Vegetable Intake [One meal per week for each intervention (Study weeks 1, 2, 3, and 4)]

   Weight of vegetables consumed at the meal (grams)

Secondary Outcome Measures

1. Difference Between Interventions in Food Intake [One meal per week for each intervention (Study weeks 1, 2, 3, and 4)]

   Weight of food (including milk) consumed at the meal (grams)

2. Difference Between Interventions in Meal Energy Intake [One meal per week for each intervention (Study weeks 1, 2, 3, and 4)]

   Energy consumed at the meal (kilocalories)

3. Difference Between Interventions in Meal Energy Density [One meal per week for each intervention (Study weeks 1, 2, 3, and 4)]

   Energy density of the food consumed at the meal (kilocalories/gram)

Other Outcome Measures

1. Preference of Vegetables Served at the Meal [Study week 5]

   Preferred version of vegetables (1=standard palatability, 2=enhanced palatability)

2. Liking of All Foods Served at the Meal [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 [Study week 5]

   Ranking of all foods in order of preference (1= most preferred, 2= next most preferred, etc.)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University	University Park	Pennsylvania	United States	16802

Sponsors and Collaborators

• Penn State University
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 26, 2020
• Informed Consent Form - Feb 26, 2020

More Information

Publications

None provided.

• 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
• Other Study ID Numbers: ChildFood402; R01DK082580
• First Posted: Apr 24, 2019
• Last Update Posted: Sep 25, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Recruitment Details	Children aged 3 to 5 years old were recruited from classrooms at three childcare centers in State College, Pennsylvania by distributing letters to parents between May 2019 and October 2019.

Arm/Group Title	St Pal/Lg PS, En Pal/St PS, St Pal/St PS, En Pal/Lg PS	En Pal/Lg PS, St Pal/St PS, En Pal/St PS, St Pal/Lg PS	En Pal/St PS, En Pal/Lg PS, St Pal/Lg PS, St Pal/St PS	St Pal/St PS, St Pal/Lg PS, En Pal/Lg PS, En Pal/St PS	En Pal/Lg PS, St Pal/Lg PS, En Pal/St PS, St Pal/St PS
Arm/Group Description	Participants who received the meals in the order of Plain Vegetables served in 200% Portion Size first, then Enhanced Vegetables served in 100% Portion Size, then Plain Vegetables served in 100% Portion Size, then Enhanced Vegetables served in 200% Portion Size	Participants who received the meals in the order of Enhanced Vegetables served in 200% Portion Size first, then Plain Vegetables served in 100% Portion Size, then Enhanced Vegetables served in 100% Portion Size, then Plain Vegetables served in 200% Portion Size	Participants who received the meals in the order of Enhanced Vegetables served in 100% Portion Size first, then Enhanced Vegetables served in 200% Portion Size, then Plain Vegetables served in 200% Portion Size, then Plain Vegetables served in 100% Portion Size	Participants who received the meals in the order of Plain Vegetables served in 100% Portion Size first, then Plain Vegetables served in 200% Portion Size, then Enhanced Vegetables served in 200% Portion Size, then Enhanced Vegetables served in 100% Portion Size	Participants who received the meals in the order of Enhanced Vegetables served in 200% Portion Size first, then Plain Vegetables served in 200% Portion Size, then Enhanced Vegetables served in 100% Portion Size, then Plain Vegetables served in 100% Portion Size
Period Title: Study Week 1
STARTED	11	9	14	18	15
COMPLETED	11	9	14	18	15
NOT COMPLETED	0	0	0	0	0
Period Title: Study Week 1
STARTED	11	9	14	18	15
COMPLETED	11	9	14	18	15
NOT COMPLETED	0	0	0	0	0
Period Title: Study Week 1
STARTED	11	9	14	18	15
COMPLETED	11	9	14	18	15
NOT COMPLETED	0	0	0	0	0
Period Title: Study Week 1
STARTED	11	9	14	18	15
COMPLETED	11	9	14	18	15
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	Enrolled participants who completed the study
Overall Participants	67
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	4.2 (0.6)
Sex: Female, Male (Count of Participants)
Female	41 61.2%
Male	26 38.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 10.4%
Not Hispanic or Latino	59 88.1%
Unknown or Not Reported	1 1.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	5 7.5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 4.5%
White	51 76.1%
More than one race	7 10.4%
Unknown or Not Reported	1 1.5%
Region of Enrollment (Count of Participants)
United States	67 100%

Outcome Measures

1. Primary Outcome

Title	Difference Between Interventions in Vegetable Intake
Description	Weight of vegetables consumed at the meal (grams)
Time Frame	One meal per week for each intervention (Study weeks 1, 2, 3, and 4)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Palatability and Standard Portion Size	Standard Palatability and Larger Portion Size	Enhanced Palatability and Standard Portion Size	Enhanced Palatability and Larger Portion Size
Arm/Group Description	Vegetables with Standard Palatability and Standard Portion Size Plain Vegetables Served in 100% Portion Size: Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables	Vegetables with Standard Palatability and Larger Portion Size Plain Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables	Vegetables with Enhanced Palatability and Standard Portion Size Enhanced Vegetables Served in 100% Portion Size: Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables	Vegetables with Enhanced Palatability and Larger Portion Size Enhanced Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables
Measure Participants	67	67	67	67
Mean (Standard Error) [grams]	32 (3)	57 (5)	31 (3)	50 (4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Palatability and Standard Portion Size, Standard Palatability and Larger Portion Size, Enhanced Palatability and Standard Portion Size, Enhanced Palatability and Larger Portion Size
	Comments	Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1260
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Standard Palatability and Standard Portion Size, Standard Palatability and Larger Portion Size, Enhanced Palatability and Standard Portion Size, Enhanced Palatability and Larger Portion Size
	Comments	Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Standard Palatability and Standard Portion Size, Standard Palatability and Larger Portion Size, Enhanced Palatability and Standard Portion Size, Enhanced Palatability and Larger Portion Size
	Comments	Interaction between Portion Size and Palatability
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0992
	Comments
	Method	Mixed Models Analysis
	Comments

2. Secondary Outcome

Title	Difference Between Interventions in Food Intake
Description	Weight of food (including milk) consumed at the meal (grams)
Time Frame	One meal per week for each intervention (Study weeks 1, 2, 3, and 4)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Palatability and Standard Portion Size	Standard Palatability and Larger Portion Size	Enhanced Palatability and Standard Portion Size	Enhanced Palatability and Larger Portion Size
Arm/Group Description	Vegetables with Standard Palatability and Standard Portion Size Plain Vegetables Served in 100% Portion Size: Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables	Vegetables with Standard Palatability and Larger Portion Size Plain Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables	Vegetables with Enhanced Palatability and Standard Portion Size Enhanced Vegetables Served in 100% Portion Size: Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables	Vegetables with Enhanced Palatability and Larger Portion Size Enhanced Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables
Measure Participants	67	67	67	67
Mean (Standard Error) [grams]	283 (10)	302 (12)	287 (10)	305 (12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Palatability and Standard Portion Size, Standard Palatability and Larger Portion Size, Enhanced Palatability and Standard Portion Size, Enhanced Palatability and Larger Portion Size
	Comments	Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5502
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Standard Palatability and Standard Portion Size, Standard Palatability and Larger Portion Size, Enhanced Palatability and Standard Portion Size, Enhanced Palatability and Larger Portion Size
	Comments	Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0072
	Comments
	Method	Mixed Models Analysis
	Comments

3. Secondary Outcome

Title	Difference Between Interventions in Meal Energy Intake
Description	Energy consumed at the meal (kilocalories)
Time Frame	One meal per week for each intervention (Study weeks 1, 2, 3, and 4)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Palatability and Standard Portion Size	Standard Palatability and Larger Portion Size	Enhanced Palatability and Standard Portion Size	Enhanced Palatability and Larger Portion Size
Arm/Group Description	Vegetables with Standard Palatability and Standard Portion Size Plain Vegetables Served in 100% Portion Size: Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables	Vegetables with Standard Palatability and Larger Portion Size Plain Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables	Vegetables with Enhanced Palatability and Standard Portion Size Enhanced Vegetables Served in 100% Portion Size: Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables	Vegetables with Enhanced Palatability and Larger Portion Size Enhanced Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables
Measure Participants	67	67	67	67
Mean (Standard Error) [kilocalories]	262 (10)	282 (10)	277 (8)	284 (11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Palatability and Standard Portion Size, Standard Palatability and Larger Portion Size, Enhanced Palatability and Standard Portion Size, Enhanced Palatability and Larger Portion Size
	Comments	Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1030
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Standard Palatability and Standard Portion Size, Standard Palatability and Larger Portion Size, Enhanced Palatability and Standard Portion Size, Enhanced Palatability and Larger Portion Size
	Comments	Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0178
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Standard Palatability and Standard Portion Size, Standard Palatability and Larger Portion Size, Enhanced Palatability and Standard Portion Size, Enhanced Palatability and Larger Portion Size
	Comments	Interaction between Portion Size and Palatability
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2410
	Comments
	Method	Mixed Models Analysis
	Comments

4. Secondary Outcome

Title	Difference Between Interventions in Meal Energy Density
Description	Energy density of the food consumed at the meal (kilocalories/gram)
Time Frame	One meal per week for each intervention (Study weeks 1, 2, 3, and 4)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Palatability and Standard Portion Size	Standard Palatability and Larger Portion Size	Enhanced Palatability and Standard Portion Size	Enhanced Palatability and Larger Portion Size
Arm/Group Description	Vegetables with Standard Palatability and Standard Portion Size Plain Vegetables Served in 100% Portion Size: Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables	Vegetables with Standard Palatability and Larger Portion Size Plain Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables	Vegetables with Enhanced Palatability and Standard Portion Size Enhanced Vegetables Served in 100% Portion Size: Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables	Vegetables with Enhanced Palatability and Larger Portion Size Enhanced Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables
Measure Participants	67	67	67	67
Mean (Standard Error) [kilocalories/gram]	1.41 (0.03)	1.35 (0.03)	1.48 (0.03)	1.40 (0.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Palatability and Standard Portion Size, Standard Palatability and Larger Portion Size, Enhanced Palatability and Standard Portion Size, Enhanced Palatability and Larger Portion Size
	Comments	Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0012
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Standard Palatability and Standard Portion Size, Standard Palatability and Larger Portion Size, Enhanced Palatability and Standard Portion Size, Enhanced Palatability and Larger Portion Size
	Comments	Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments

5. Other Pre-specified Outcome

Title	Preference of Vegetables Served at the Meal
Description	Preferred version of vegetables (1=standard palatability, 2=enhanced palatability)
Time Frame	Study week 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Other Pre-specified Outcome

Title	Liking of All Foods Served at the Meal
Description	The Yummy-Yucky Cartoon Faces Scale (1=Yucky, 2=Just Okay, and 3=Yummy)
Time Frame	Study week 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Other Pre-specified Outcome

Title	Ranking of All Foods Served at the Meal
Description	Ranking of all foods in order of preference (1= most preferred, 2= next most preferred, etc.)
Time Frame	Study week 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	5 weeks
Arm/Group Title	Standard Palatability and Standard Portion Size		Standard Palatability and Larger Portion Size		Enhanced Palatability and Standard Portion Size		Enhanced Palatability and Larger Portion Size
Arm/Group Description	Vegetables with Standard Palatability and Standard Portion Size Plain Vegetables Served in 100% Portion Size: Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables		Vegetables with Standard Palatability and Larger Portion Size Plain Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables		Vegetables with Enhanced Palatability and Standard Portion Size Enhanced Vegetables Served in 100% Portion Size: Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables		Vegetables with Enhanced Palatability and Larger Portion Size Enhanced Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables
All Cause Mortality
	Standard Palatability and Standard Portion Size		Standard Palatability and Larger Portion Size		Enhanced Palatability and Standard Portion Size		Enhanced Palatability and Larger Portion Size
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/67 (0%)		0/67 (0%)		0/67 (0%)
Serious Adverse Events
	Standard Palatability and Standard Portion Size		Standard Palatability and Larger Portion Size		Enhanced Palatability and Standard Portion Size		Enhanced Palatability and Larger Portion Size
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/67 (0%)		0/67 (0%)		0/67 (0%)
Other (Not Including Serious) Adverse Events
	Standard Palatability and Standard Portion Size		Standard Palatability and Larger Portion Size		Enhanced Palatability and Standard Portion Size		Enhanced Palatability and Larger Portion Size
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/67 (0%)		0/67 (0%)		0/67 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.