Feeding BehaviorNCT03643250
Effects of Varying Portion Size and Palatability on Food Intake of Preschool Children
A study testing Smaller Portion Size and Standard Appeal (non-divided plate), Smaller Portion Size and Enhanced Appeal (divided plate) and Larger Portion Size and Standard Appeal (non-divided plate) in people with Feeding Behavior, run by Penn State University at 1 site in United States.
Trial 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. 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?
- Smaller Portion Size and Standard Appeal (non-divided plate), Smaller Portion Size and Enhanced Appeal (divided plate) and Larger Portion Size and Standard Appeal (non-divided plate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2019to 17 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
About this study
Official title: Lunch Feeding Study for Preschool Children
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.
- Conditions
- Feeding Behavior
- Being tested
- Smaller Portion Size and Standard Appeal (non-divided plate), Smaller Portion Size and Enhanced Appeal (divided plate), Larger Portion Size and Standard Appeal (non-divided plate), Larger Portion Size and Enhanced Appeal (divided plate), Smaller Portion Size and Standard Appeal (divided plate)
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smaller Portion Size and Standard Appeal (non-divided plate)Other
Food with Smaller Portion Size and Standard Appeal on a non-divided plate
Smaller Portion Size and Enhanced Appeal (divided plate)Other
Food with Smaller Portion Size and Enhanced Appeal on a divided plate
Larger Portion Size and Standard Appeal (non-divided plate)Other
Food with Larger Portion Size and Standard Appeal on a non-divided plate
Larger Portion Size and Enhanced Appeal (divided plate)Other
Food with Larger Portion Size and Enhanced Appeal on a divided plate
Smaller Portion Size and Standard Appeal (divided plate)Other
Food with Smaller Portion Size and Standard Appeal on a divided plate
| Study group | Role | What they receive |
|---|---|---|
| Smaller Portion Size and Standard Appeal (non-divided plate) | Experimental | Food with Smaller Portion Size and Standard Appeal on a non-divided plate Receives: Other: Smaller Portion Size and Standard Appeal (non-divided plate) |
| Smaller Portion Size and Enhanced Appeal (divided plate) | Experimental | Food with Smaller Portion Size and Enhanced Appeal on a divided plate Receives: Other: Smaller Portion Size and Enhanced Appeal (divided plate) |
| Larger Portion Size and Standard Appeal (non-divided plate) | Experimental | Food with Larger Portion Size and Standard Appeal on a non-divided plate Receives: Other: Larger Portion Size and Standard Appeal (non-divided plate) |
| Larger Portion Size and Enhanced Appeal (divided plate) | Experimental | Food with Larger Portion Size and Enhanced Appeal on a divided plate Receives: Other: Larger Portion Size and Enhanced Appeal (divided plate) |
| Smaller Portion Size and Standard Appeal (divided plate) | Experimental | Food with Smaller Portion Size and Standard Appeal on a divided plate Receives: Other: Smaller Portion Size and Standard Appeal (divided plate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between interventions in meal energy intake
Energy consumed at the meal (kcal)
Measured: Study weeks 1, 2, 3, 4, and 5
Secondary outcomes (2)
Difference between interventions in food intake
Weight of food consumed at the meal (g)
Measured: Study weeks 1, 2, 3, 4, and 5
Difference between interventions in meal energy density
Energy density of the food consumed at the meal (kcal/g)
Measured: Study weeks 1, 2, 3, 4, and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start12 Mar 2019
- Primary completion9 Apr 2019
- Study completion17 Apr 2019
Why it stopped: We observed reduced intake by the fifth week, so we are shortening the study and simplifying it by using a complete factorial design with four conditions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara J. Rolls, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643250
- Sponsor's protocol ID
- ChildFood401
- Other IDs
- R01DK082580
- Status last verified
- Apr 2019
- First submitted
- 21 Aug 2018
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lunch Feeding Study for Preschool Children
- ClinicalTrials.gov ID
- NCT03643250
- Acronym / sponsor ID
- ChildFood401
- Conditions
- Feeding Behavior
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We observed reduced intake by the fifth week, so we are shortening the study and simplifying it by using a complete factorial design with four conditions.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Smaller Portion Size and Standard Appeal (non-divided plate) | Experimental | Other: Smaller Portion Size and Standard Appeal (non-divided plate)Food with Smaller Portion Size and Standard Appeal on a non-divided plate |
| Smaller Portion Size and Enhanced Appeal (divided plate) | Experimental | Other: Smaller Portion Size and Enhanced Appeal (divided plate)Food with Smaller Portion Size and Enhanced Appeal on a divided plate |
| Larger Portion Size and Standard Appeal (non-divided plate) | Experimental | Other: Larger Portion Size and Standard Appeal (non-divided plate)Food with Larger Portion Size and Standard Appeal on a non-divided plate |
| Larger Portion Size and Enhanced Appeal (divided plate) | Experimental | Other: Larger Portion Size and Enhanced Appeal (divided plate)Food with Larger Portion Size and Enhanced Appeal on a divided plate |
| Smaller Portion Size and Standard Appeal (divided plate) | Experimental | Other: Smaller Portion Size and Standard Appeal (divided plate)Food with Smaller Portion Size and Standard Appeal on a divided plate |
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 |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
Primary outcome
Difference between interventions in meal energy intake
Time frame: Study weeks 1, 2, 3, 4, and 5
Energy consumed at the meal (kcal)
2 secondary outcomes
Difference between interventions in food intake
Time frame: Study weeks 1, 2, 3, 4, and 5
Difference between interventions in meal energy density
Time frame: Study weeks 1, 2, 3, 4, and 5
Results and safety
The study was stopped early (reason given: We observed reduced intake by the fifth week, so we are shortening the study and simplifying it by using a complete factorial design with four conditions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- 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?
A study testing Smaller Portion Size and Standard Appeal (non-divided plate), Smaller Portion Size and Enhanced Appeal (divided plate) and Larger Portion Size and Standard Appeal (non-divided plate) in people with Feeding Behavior, run by Penn State University at 1 site in United States.
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: stopped early, as of the sponsor's last update on 22 Apr 2019. 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?
The study was stopped early (reason given: We observed reduced intake by the fifth week, so we are shortening the study and simplifying it by using a complete factorial design with four conditions.). Results are not available in the source record.
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 meal energy intake (time frame: Study weeks 1, 2, 3, 4, and 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2019.