Feeding BehaviorNCT03010501
Effect of Energy Density Over 5 Days in Preschool Children
A study testing Food Energy Density in people with Feeding Behavior, run by Penn State University at 1 site in United States.
Trial summary
In this study, the investigators will vary the energy density of foods served during three 5-day periods. There will be a baseline condition, and then a condition where the energy density of food is lower and a condition where the energy density of food is higher. 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?
- Food Energy Density
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2017
- 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
- Attending one of the designated daycare centers
Who cannot join
- Food Allergies
- Food restrictions
- Health Issues that Preclude Participation
- Not available for duration of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory for the Study of Human Ingestive Behavior
University Park, Pennsylvania, 16802
About this study
In this study, the investigators will vary the energy density of foods served during three 5-day periods. There will be a baseline condition, and then a condition where the energy density of food is lower and a condition where the energy density of food is higher. The primary aim is to determine the effect of varying the energy density of foods served over 5 days on energy intake in preschool children. It is hypothesized that mean daily energy intake will be greater when children are served higher energy dense foods over 5 days than when served lower energy dense foods over the same period. Additionally, it is hypothesized that daily energy intake in the conditions with higher and lower energy densities will begin to converge across the 5-day period.
- Conditions
- Feeding Behavior
- Being tested
- Food Energy Density
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Energy DensityOther
Food Energy density manipulated
| Study group | Role | What they receive |
|---|---|---|
| 100% Food Energy Density | Experimental | Baseline Food Energy Density Receives: Other: Food Energy Density |
| 80% Food Energy Density | Experimental | Lower Food Energy Density Receives: Other: Food Energy Density |
| 120% Food Energy Density | Experimental | Higher Food Energy Density Receives: Other: Food Energy Density |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Food and Beverage Intake by Energy
Differences in daily intake of food and beverages by energy, in kcal
Measured: Days 1-5 in Weeks 1, 2, and 3
Differences in Food and Beverage Intake by Weight
Differences in daily intake of food and beverages by weight, in grams
Measured: Days 1-5 in weeks 1, 2, and 3
Secondary outcomes (1)
Differences in Food and Beverage Intake by Energy Density
Differences in daily intake of food and beverages by energy density, in kcal/g
Measured: Days 1-5 in weeks 1, 2, and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionDec 2017
- Study completionDec 2017
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 (2)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 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, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010501
- Sponsor's protocol ID
- ChildFood502
- Other IDs
- R01DK082580
- Status last verified
- Jul 2019
- First submitted
- 22 Dec 2016
- Last updated
- 11 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rolls BJ, Roe LS, Keller KL. Children's Energy Intake Generally Increases in Response to the Energy Density of Meals but Varies with the Amounts and Types of Foods Served. Am J Clin Nutr. 2024 Jan;119(1):185-195. doi: 10.1016/j.ajcnut.2023.10.019. Epub 2023 Oct 27.
PubMed 37890673Roe LS, Keller KL, Rolls BJ. Food Properties and Individual Characteristics Influence Children's Intake Across Multiple Days of Weighed Assessments in Childcare Programs. J Nutr. 2023 May;153(5):1646-1655. doi: 10.1016/j.tjnut.2023.03.025. Epub 2023 Mar 24.
PubMed 36965692
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Energy Density Over 5 Days in Preschool Children
- ClinicalTrials.gov ID
- NCT03010501
- Acronym / sponsor ID
- ChildFood502
- Conditions
- Feeding Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Posted 11 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators will vary the energy density of foods served during three 5-day periods. There will be a baseline condition, and then a condition where the energy density of food is lower and a condition where the energy density of food is higher. The primary aim is to determine the effect of varying the energy density of foods served over 5 days on energy intake in preschool children. It is hypothesized that mean daily energy intake will be greater when children are served higher energy dense foods over 5 days than when served lower energy dense foods over the same period. Additionally, it is hypothesized that daily energy intake in the conditions with higher and lower energy densities will begin to converge across the 5-day period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 100% Food Energy Density | Experimental | Other: Food Energy DensityBaseline Food Energy Density |
| 80% Food Energy Density | Experimental | Other: Food Energy DensityLower Food Energy Density |
| 120% Food Energy Density | Experimental | Other: Food Energy DensityHigher Food Energy Density |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Attending one of the designated daycare centers
Key exclusion criteria (4 listed)
- Food Allergies
- Food restrictions
- Health Issues that Preclude Participation
- Not available for duration of the study
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 |
|---|---|---|
| Food Energy DensityFood Energy density manipulated | Other | 100% Food Energy Density, 120% Food Energy Density, 80% Food Energy Density |
Primary outcome
Differences in Food and Beverage Intake by Energy
Time frame: Days 1-5 in Weeks 1, 2, and 3
Differences in daily intake of food and beverages by energy, in kcal
Differences in Food and Beverage Intake by Weight
Time frame: Days 1-5 in weeks 1, 2, and 3
Differences in daily intake of food and beverages by weight, in grams
1 secondary outcome
Differences in Food and Beverage Intake by Energy Density
Time frame: Days 1-5 in weeks 1, 2, and 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37890673Rolls BJ, Roe LS, Keller KL. Children's Energy Intake Generally Increases in Response to the Energy Density of Meals but Varies with the Amounts and Types of Foods Served. Am J Clin Nutr. 2024 Jan;119(1):185-195. doi: 10.1016/j.ajcnut.2023.10.019. Epub 2023 Oct 27.
- Derived from this study: PubMed 36965692Roe LS, Keller KL, Rolls BJ. Food Properties and Individual Characteristics Influence Children's Intake Across Multiple Days of Weighed Assessments in Childcare Programs. J Nutr. 2023 May;153(5):1646-1655. doi: 10.1016/j.tjnut.2023.03.025. Epub 2023 Mar 24.
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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 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 Food Energy Density 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 4 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 11 Jul 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?
Yes. Results are posted in the registry (first posted 11 Jul 2019). 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?
Differences in Food and Beverage Intake by Energy (time frame: Days 1-5 in Weeks 1, 2, and 3). The study lists 2 primary outcomes in all. 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 NCT03010501, which also lists 2 linked publications.
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 11 Jul 2019.