Feeding BehaviorNCT03926065

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

A study testing Plain Vegetables Served in 100% Portion Size, Plain Vegetables Served in 200% Portion Size and Enhanced Vegetables Served in 100% Portion Size in people with Feeding Behavior, run by Penn State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 3 to 5 years
Conditions the study is for: Feeding Behavior
What is being tested?: Plain Vegetables Served in 100% Portion Size, Plain Vegetables Served in 200% Portion Size and Enhanced Vegetables Served in 100% Portion Size
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 1 siteUnited States
Study dates: 28 May 2019to 29 Oct 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 5 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University
University Park, Pennsylvania, 16802

Other trials in United States

About this study

Official title: Lunchtime Meal Feeding Study for Preschool Children

Conditions: Feeding Behavior
Being tested: Plain Vegetables Served in 100% Portion Size, Plain Vegetables Served in 200% Portion Size, Enhanced Vegetables Served in 100% Portion Size, Enhanced Vegetables Served in 200% Portion Size
Medical subject headings: Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Plain Vegetables Served in 100% Portion SizeOther
Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables
Plain Vegetables Served in 200% Portion SizeOther
Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables
Enhanced Vegetables Served in 100% Portion SizeOther
Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables
Enhanced Vegetables Served in 200% Portion SizeOther
Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables

Study groups in NCT03926065
Study group	Role	What they receive
Standard Palatability and Standard Portion Size	Experimental	Vegetables with Standard Palatability and Standard Portion Size Receives: Other: Plain Vegetables Served in 100% Portion Size
Standard Palatability and Larger Portion Size	Experimental	Vegetables with Standard Palatability and Larger Portion Size Receives: Other: Plain Vegetables Served in 200% Portion Size
Enhanced Palatability and Standard Portion Size	Experimental	Vegetables with Enhanced Palatability and Standard Portion Size Receives: Other: Enhanced Vegetables Served in 100% Portion Size
Enhanced Palatability and Larger Portion Size	Experimental	Vegetables with Enhanced Palatability and Larger Portion Size Receives: Other: Enhanced Vegetables Served in 200% Portion Size

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Difference Between Interventions in Food Intake
Weight of food (including milk) consumed at the meal (grams)
Measured: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
Difference Between Interventions in Meal Energy Intake
Energy consumed at the meal (kilocalories)
Measured: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
Difference Between Interventions in Meal Energy Density
Energy density of the food consumed at the meal (kilocalories/gram)
Measured: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 May 201929 Oct 2019

First posted24 Apr 2019
Study start28 May 2019
Primary completion24 Oct 2019
Study completion29 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Feeding BehaviorStudies of the same condition, open and under way.
More trials run by Penn State UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03926065
Sponsor's protocol ID: ChildFood402
Other IDs: R01DK082580
Status last verified: Sep 2020
First submitted: 19 Apr 2019
Last updated: 25 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33836215

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Feeding Behavior trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lunchtime Meal Feeding Study for Preschool Children
ClinicalTrials.gov ID: NCT03926065
Acronym / sponsor ID: ChildFood402
Conditions: Feeding Behavior
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Penn State UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 28 May 2019 (actual)
Primary completion: 24 Oct 2019 (actual)
Study completion: 29 Oct 2019 (actual)
First posted: 24 Apr 2019 (actual)
Results: Posted 4 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, care provider)
Number of arms: 4

Arm	Type	Receives
Standard Palatability and Standard Portion Size	Experimental	Other: Plain Vegetables Served in 100% Portion SizeVegetables with Standard Palatability and Standard Portion Size
Standard Palatability and Larger Portion Size	Experimental	Other: Plain Vegetables Served in 200% Portion SizeVegetables with Standard Palatability and Larger Portion Size
Enhanced Palatability and Standard Portion Size	Experimental	Other: Enhanced Vegetables Served in 100% Portion SizeVegetables with Enhanced Palatability and Standard Portion Size
Enhanced Palatability and Larger Portion Size	Experimental	Other: Enhanced Vegetables Served in 200% Portion SizeVegetables with Enhanced Palatability and Larger Portion Size

Who may qualify

Ages: 3 to 5 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Plain Vegetables Served in 100% Portion SizeLunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables	Other	Standard Palatability and Standard Portion Size
Plain Vegetables Served in 200% Portion SizeLunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables	Other	Standard Palatability and Larger Portion Size
Enhanced Vegetables Served in 100% Portion SizeLunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables	Other	Enhanced Palatability and Standard Portion Size
Enhanced Vegetables Served in 200% Portion SizeLunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables	Other	Enhanced Palatability and Larger Portion Size

Primary outcome

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

3 secondary outcomes

Difference Between Interventions in Food Intake
Time frame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
Difference Between Interventions in Meal Energy Intake
Time frame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
Difference Between Interventions in Meal Energy Density
Time frame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)

Results and safety

Results posted to the registry on 4 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
St Pal/Lg PS, En Pal/St PS, St Pal/St PS, En Pal/Lg PS	11	11
En Pal/Lg PS, St Pal/St PS, En Pal/St PS, St Pal/Lg PS	9	9
En Pal/St PS, En Pal/Lg PS, St Pal/Lg PS, St Pal/St PS	14	14
St Pal/St PS, St Pal/Lg PS, En Pal/Lg PS, En Pal/St PS	18	18
En Pal/Lg PS, St Pal/Lg PS, En Pal/St PS, St Pal/St PS	15	15

Primary outcome: Difference Between Interventions in Vegetable Intake

Time frame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4). Mean (Standard Error). Unit: grams

Measure	Standard Palatability and Standard Portion Size n = 67	Standard Palatability and Larger Portion Size n = 67	Enhanced Palatability and Standard Portion Size n = 67	Enhanced Palatability and Larger Portion Size n = 67
Value	32 (3)	57 (5)	31 (3)	50 (4)

Standard Palatability and Standard Portion Size vs Standard Palatability and Larger Portion Size vs Enhanced Palatability and Standard Portion Size vs Enhanced Palatability and Larger Portion Size: p = 0.1260, Mixed Models Analysis
Standard Palatability and Standard Portion Size vs Standard Palatability and Larger Portion Size vs Enhanced Palatability and Standard Portion Size vs Enhanced Palatability and Larger Portion Size: p <0.0001, Mixed Models Analysis
Standard Palatability and Standard Portion Size vs Standard Palatability and Larger Portion Size vs Enhanced Palatability and Standard Portion Size vs Enhanced Palatability and Larger Portion Size: p = 0.0992, Mixed Models Analysis

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Palatability and Standard Portion Size	0 of 67 (0%)	0 of 67 (0%)	0 of 67
Standard Palatability and Larger Portion Size	0 of 67 (0%)	0 of 67 (0%)	0 of 67
Enhanced Palatability and Standard Portion Size	0 of 67 (0%)	0 of 67 (0%)	0 of 67
Enhanced Palatability and Larger Portion Size	0 of 67 (0%)	0 of 67 (0%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33836215Diktas 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference Between Interventions in Vegetable Intake (time frame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03926065, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.