Feeding BehaviorsNCT02299531
Effects of Portion Size and Energy Density of a Single Meal in Preschool Children
A study testing Varying meal energy density and portion size in people with Feeding Behaviors, run by Penn State University at 1 site in United States.
Trial summary
This study investigates the effect of varying both energy density and portion size of all foods at lunch on preschool children's intake. The foods used in this study are commercially-available, commonly-consumed foods with typical variations in energy density. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Feeding Behaviors
- What is being tested?
- Varying meal energy density and portion size
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Aug 2014
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children must be enrolled in participating childcare centers.
Who cannot join
- Allergy or intolerance to any of the foods or beverages served.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior
University Park, Pennsylvania, 16802
About this study
This study investigates the effect of varying both energy density and portion size of all foods at lunch on preschool children's intake. The foods used in this study are commercially-available, commonly-consumed foods with typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of energy density and portion size on preschool children's intake at a meal composed of foods typically served to this population.
- Conditions
- Feeding Behaviors
- Being tested
- Varying meal energy density and 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.
Varying meal energy density and portion sizeOther
| Study group | Role | What they receive |
|---|---|---|
| Low Energy Density, Small Portions | Experimental | Low meal energy density and small portion sizes Receives: Other: Varying meal energy density and portion size |
| Low Energy Density, Medium Portions | Experimental | Low meal energy density and medium portion sizes Receives: Other: Varying meal energy density and portion size |
| Low Energy Density, Large Portions | Experimental | Low meal energy density and large portion sizes Receives: Other: Varying meal energy density and portion size |
| High Energy Density, Small Portions | Experimental | High meal energy density and small portion sizes Receives: Other: Varying meal energy density and portion size |
| High Energy Density, Medium Portions | Experimental | High meal energy density and medium portion sizes Receives: Other: Varying meal energy density and portion size |
| High Energy Density, Large Portions | Experimental | High meal energy density and large portion sizes Receives: Other: Varying meal energy density and portion size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food and energy intake (Food weight (grams) and energy (kcal)
Measured: Once a week for four weeks
Secondary outcomes (1)
Meal energy density (Energy density (kcal/g)
Energy density (kcal/g)
Measured: Once a week for four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startMay 2013
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feeding BehaviorsStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 131 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
- Investigators
- Barbara J Rolls, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299531
- Sponsor's protocol ID
- ChildFood201
- Other IDs
- R01DK082580
- Status last verified
- Nov 2014
- First submitted
- 19 Nov 2014
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kling SM, Roe LS, Keller KL, Rolls BJ. Double trouble: Portion size and energy density combine to increase preschool children's lunch intake. Physiol Behav. 2016 Aug 1;162:18-26. doi: 10.1016/j.physbeh.2016.02.019. Epub 2016 Feb 12.
PubMed 26879105
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Portion Size and Energy Density of a Single Meal in Preschool Children
- ClinicalTrials.gov ID
- NCT02299531
- Acronym / sponsor ID
- ChildFood201
- Conditions
- Feeding Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2013
- Primary completion
- Aug 2014 (actual)
- First posted
- 24 Nov 2014 (estimated)
- 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.
This study investigates the effect of varying both energy density and portion size of all foods at lunch on preschool children's intake. The foods used in this study are commercially-available, commonly-consumed foods with typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of energy density and portion size on preschool children's intake at a meal composed of foods typically served to this population.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Low Energy Density, Small Portions | Experimental | Other: Varying meal energy density and portion sizeLow meal energy density and small portion sizes |
| Low Energy Density, Medium Portions | Experimental | Other: Varying meal energy density and portion sizeLow meal energy density and medium portion sizes |
| Low Energy Density, Large Portions | Experimental | Other: Varying meal energy density and portion sizeLow meal energy density and large portion sizes |
| High Energy Density, Small Portions | Experimental | Other: Varying meal energy density and portion sizeHigh meal energy density and small portion sizes |
| High Energy Density, Medium Portions | Experimental | Other: Varying meal energy density and portion sizeHigh meal energy density and medium portion sizes |
| High Energy Density, Large Portions | Experimental | Other: Varying meal energy density and portion sizeHigh meal energy density and large portion sizes |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children must be enrolled in participating childcare centers.
Key exclusion criteria (1 listed)
- Allergy or intolerance to any of the foods or beverages served.
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 |
|---|---|---|
| Varying meal energy density and portion size | Other | High Energy Density, Large Portions, High Energy Density, Medium Portions, High Energy Density, Small Portions, Low Energy Density, Large Portions, Low Energy Density, Medium Portions, Low Energy Density, Small Portions |
Primary outcome
Food and energy intake (Food weight (grams) and energy (kcal)
Time frame: Once a week for four weeks
1 secondary outcome
Meal energy density (Energy density (kcal/g)
Time frame: Once a week for four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Derived from this study: PubMed 26879105Kling SM, Roe LS, Keller KL, Rolls BJ. Double trouble: Portion size and energy density combine to increase preschool children's lunch intake. Physiol Behav. 2016 Aug 1;162:18-26. doi: 10.1016/j.physbeh.2016.02.019. Epub 2016 Feb 12.
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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.
Barbara J Rolls, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Varying meal energy density and portion size in people with Feeding Behaviors, 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 1 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 24 Nov 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Food and energy intake (Food weight (grams) and energy (kcal) (time frame: Once a week for four weeks). 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 NCT02299531, 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 24 Nov 2014.