Feeding BehaviorsNCT02755558
Effects of Energy Density and Portion Size of Milk in Preschool Children
A study testing Low energy density, High energy density and Small portion in people with Feeding Behaviors, run by Penn State University at 1 site in United States.
Trial summary
In this study, the investigators varied both the energy density and portion size of milk served with a meal commonly consumed by preschool children. The milk used in this study is commercially available and reflects 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?
- Low energy density, High energy density and Small portion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to May 2015
- 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
In this study, the investigators varied both the energy density and portion size of milk served with a meal commonly consumed by preschool children. The milk used in this study is commercially available and reflects typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of milk energy density and portion size on preschool children's intake of the milk and the simultaneously served meal. The effect of milk energy density and portion size on children's total energy intake at the meal will also be evaluated.
- Conditions
- Feeding Behaviors
- Being tested
- Low energy density, High energy density, Small portion, Large portion
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low energy densityBehavioural
Low energy density milk served
High energy densityBehavioural
High energy density milk served
Small portionBehavioural
Small portion of milk served
Large portionBehavioural
Large portion of milk served
| Study group | Role | What they receive |
|---|---|---|
| Low energy density, small portion | Experimental | Low milk energy density and small portion size Receives: Behavioral: Low energy density; Behavioral: Small portion |
| Low energy density, large portion | Experimental | Low milk energy density and large portion size Receives: Behavioral: Low energy density; Behavioral: Large portion |
| High energy density, small portion | Experimental | High milk energy density and small portion size Receives: Behavioral: High energy density; Behavioral: Small portion |
| High energy density, large portion | Experimental | High milk energy density and large portion size Receives: Behavioral: High energy density; Behavioral: Large portion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between experimental conditions for milk, food, and total intake by weight
Difference between experimental conditions in milk intake (weight in grams), food intake (weight in grams), total meal intake (weight in grams)
Measured: once a week for 4 weeks
Difference between experiential conditions for milk, food, and total intake by energy
Difference between experimental conditions for milk intake (energy in kcal), food intake (energy in kcal), and total meal energy intake (energy in kcal)
Measured: once a week for 4 weeks
Secondary outcomes (1)
Meal energy density
Meal energy density (energy density in kcal/g)
Measured: once a week for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 143 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, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755558
- Sponsor's protocol ID
- ChildFood301
- Other IDs
- R01DK082580, 2011-67001-30117
- Status last verified
- Mar 2017
- First submitted
- 22 Apr 2016
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Energy Density and Portion Size of Milk in Preschool Children
- ClinicalTrials.gov ID
- NCT02755558
- Acronym / sponsor ID
- ChildFood301
- Conditions
- Feeding Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 29 Apr 2016 (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.
In this study, the investigators varied both the energy density and portion size of milk served with a meal commonly consumed by preschool children. The milk used in this study is commercially available and reflects typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of milk energy density and portion size on preschool children's intake of the milk and the simultaneously served meal. The effect of milk energy density and portion size on children's total energy intake at the meal will also be evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low energy density, small portion | Experimental | Behavioral: Low energy density, Behavioral: Small portionLow milk energy density and small portion size |
| Low energy density, large portion | Experimental | Behavioral: Low energy density, Behavioral: Large portionLow milk energy density and large portion size |
| High energy density, small portion | Experimental | Behavioral: High energy density, Behavioral: Small portionHigh milk energy density and small portion size |
| High energy density, large portion | Experimental | Behavioral: High energy density, Behavioral: Large portionHigh milk energy density and large portion size |
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 |
|---|---|---|
| Low energy densityLow energy density milk served | Behavioural | Low energy density, large portion, Low energy density, small portion |
| High energy densityHigh energy density milk served | Behavioural | High energy density, large portion, High energy density, small portion |
| Small portionSmall portion of milk served | Behavioural | High energy density, small portion, Low energy density, small portion |
| Large portionLarge portion of milk served | Behavioural | High energy density, large portion, Low energy density, large portion |
Primary outcome
Difference between experimental conditions for milk, food, and total intake by weight
Time frame: once a week for 4 weeks
Difference between experimental conditions in milk intake (weight in grams), food intake (weight in grams), total meal intake (weight in grams)
Difference between experiential conditions for milk, food, and total intake by energy
Time frame: once a week for 4 weeks
Difference between experimental conditions for milk intake (energy in kcal), food intake (energy in kcal), and total meal energy intake (energy in kcal)
1 secondary outcome
Meal energy density
Time frame: once a week for 4 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 21 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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
The Pennsylvania 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 Low energy density, High energy density and Small portion 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 21 Mar 2017. 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?
Difference between experimental conditions for milk, food, and total intake by weight (time frame: once a week for 4 weeks). 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?
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 21 Mar 2017.