Caloric IntakeNCT00936507
Does Portion Size Influence Intake of Low-Energy-Dense Foods in Preschool-aged Children?
A study testing Energy Density/Portion Size in people with Caloric Intake, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
The purpose of this randomized controlled study using a crossover design is to investigate the main effect of portion size and food type (low-energy dense vs. high-energy dense) on caloric intake. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caloric Intake
- What is being tested?
- Energy Density/Portion Size
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All children that are ≥3 years of age enrolled in the ELC preschool with parental consent can participate.
- Eligible children must also like both the applesauce and the pudding, and be able to consume foods with a spoon.
Who cannot join
- Children allergic to applesauce or chocolate pudding or who are lactose- intolerant will not be included in the study.
- Did not attend all feeding sessions.
- Did not consume more than 5 grams from any of the foods on an occasion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Eating and Activity Laboratory, University of Tennessee
Knoxville, Tennessee, 37996
About this study
The purpose of this randomized controlled study using a crossover design is to investigate the main effect of portion size and food type (low-energy dense vs. high-energy dense) on caloric intake.
Read the detailed description
The purpose of this investigation is to examine the impact of portion size on intake of a low energy dense food (fruit). Preschool-aged children will be provided with a small and large portion of applesauce (low-energy-dense food) and chocolate pudding (higher-energy-dense food) and allowed to eat the foods ad libitum during an afternoon snack in their usual preschool classroom. Measures of the amount of each food (grams and kilocalories) consumed will be taken.
The following hypotheses are proposed:
- A significant main effect of portion size will occur, such that children will consume more food, both in grams and kilocalories, in the large portion as compared to the small portion conditions.
- A main effect of food type on caloric intake will occur, such that children will consume less calories in the applesauce condition as compared to the pudding condition, due to the differences in energy density of these foods. It is not anticipated that a difference in grams consumed from each food will occur.
- Conditions
- Caloric Intake
- Being tested
- Energy Density/Portion Size
- Keywords
- energy density, portion size, child feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy Density/Portion SizeOther
| Study group | Role | What they receive |
|---|---|---|
| Low-ED, small portion | Experimental | Not described Receives: Other: Energy Density/Portion Size |
| Low-ED, large portion | Experimental | Not described Receives: Other: Energy Density/Portion Size |
| High-ED, small portion | Experimental | Not described Receives: Other: Energy Density/Portion Size |
| High-ED, large portion | Experimental | Not described Receives: Other: Energy Density/Portion Size |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caloric IntakeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936507
- Sponsor's protocol ID
- 1-Smith
- Status last verified
- Apr 2018
- First submitted
- 8 Jul 2009
- Last updated
- 5 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Portion Size Influence Intake of Low-Energy-Dense Foods in Preschool-aged Children?
- ClinicalTrials.gov ID
- NCT00936507
- Acronym / sponsor ID
- 1-Smith
- Conditions
- Caloric Intake
- Keywords
- energy density, portion size, child feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Sep 2008 (actual)
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 10 Jul 2009 (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.
The purpose of this randomized controlled study using a crossover design is to investigate the main effect of portion size and food type (low-energy dense vs. high-energy dense) on caloric intake.
Detailed description
The purpose of this investigation is to examine the impact of portion size on intake of a low energy dense food (fruit). Preschool-aged children will be provided with a small and large portion of applesauce (low-energy-dense food) and chocolate pudding (higher-energy-dense food) and allowed to eat the foods ad libitum during an afternoon snack in their usual preschool classroom. Measures of the amount of each food (grams and kilocalories) consumed will be taken.
The following hypotheses are proposed:
- A significant main effect of portion size will occur, such that children will consume more food, both in grams and kilocalories, in the large portion as compared to the small portion conditions.
- A main effect of food type on caloric intake will occur, such that children will consume less calories in the applesauce condition as compared to the pudding condition, due to the differences in energy density of these foods. It is not anticipated that a difference in grams consumed from each food will occur.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-ED, small portion | Experimental | Other: Energy Density/Portion Size |
| Low-ED, large portion | Experimental | Other: Energy Density/Portion Size |
| High-ED, small portion | Experimental | Other: Energy Density/Portion Size |
| High-ED, large portion | Experimental | Other: Energy Density/Portion Size |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All children that are ≥3 years of age enrolled in the ELC preschool with parental consent can participate.
- Eligible children must also like both the applesauce and the pudding, and be able to consume foods with a spoon.
Key exclusion criteria (3 listed)
- Children allergic to applesauce or chocolate pudding or who are lactose- intolerant will not be included in the study.
- Did not attend all feeding sessions.
- Did not consume more than 5 grams from any of the foods on an occasion.
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 |
|---|---|---|
| Energy Density/Portion Size | Other | High-ED, large portion, High-ED, small portion, Low-ED, large portion, Low-ED, small portion |
Primary outcome
Not reported in the source record.
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 5 Apr 2018.
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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 Energy Density/Portion Size in people with Caloric Intake, run by The University of Tennessee, Knoxville 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 2 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 5 Apr 2018. 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.
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 5 Apr 2018.