EatingNCT00436878
Intake Promoting Effects of Large Portions in Children
A study testing Food portion size in people with Eating, run by Temple University at 2 sites in United States.
Trial summary
The purpose of this study is to test the effects of large food portions on children's eating. Experiment 1 will test the effect of portion size on children's consumption of sweetened beverages; we hypothesize that serving large beverage portions will increase the amount of energy children consume from this food. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating
- What is being tested?
- Food portion size
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2005to Apr 2011
- 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 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 5 to 6 years
Who cannot join
- severe food allergies
- chronic illnesses or medication use affecting food intake
- dislike of foods on the menu
Trial locations and contacts
2 sites in 1 country.
United States2 sites
USDA\ARS Children's Nutrition Research Center
Houston, Texas, 77030
Center for Obesity Research, Temple University
Philadelphia, Pennsylvania, 19140
About this study
The purpose of this study is to test the effects of large food portions on children's eating. Experiment 1 will test the effect of portion size on children's consumption of sweetened beverages; we hypothesize that serving large beverage portions will increase the amount of energy children consume from this food. Experiment 2 will test the effects of portion size on children's intake of fruits and vegetables (FV) affect intake whether such effects are moderated by children's FV preferences and; we hypothesize that serving large fruit and vegetable portions will produce increases in children's intake of these foods, particularly for children who like fruit and vegetables. Experiment 3 will evaluate how food energy density affects children's response to large portions; we hypothesize that large portions will have the greatest influence on children's energy consumption when foods are energy dense. Experiment 4 will begin to address perceptual mechanisms by which large portions affect children's eating.
Read the detailed description
The emerging epidemic of overweight among underscores the need to identify contributing environmental factors. Marketplace trends for excessive and growing portion sizes in and outside the home have reinforced concerns that large portions may directly contribute by promoting excessive intake. To date, however, systematic investigation of portion size effects on children's eating has been extremely limited. Two laboratory studies have reported that serving large portions of macaroni and cheese to young children promoted energy consumption at meals. Whether portion size effects would be seen with other foods of varying energy content and preference is unknown. Of particular public health interest is whether serving large portions may affect children's intake of sweetened beverages, fruits and vegetables, and energy dense foods. This study will address these questions using an experimental approach to test the effects of portion size on children's eating.
- Conditions
- Eating
- Being tested
- Food portion size
- Keywords
- Eating Behavior, Children, Portion size, Experimental
- 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 portion sizeBehavioural
Each of four experiments involves a 2 x 2 within-subjects factorial design, in which the first factor is the portion size of a food served to children: foods will be served in a reference amount (i.e. 250 g macaroni and cheese) or doubled in size(i.e. 500 g of macaroni and cheese). In the Experiment 1, the second factor of the 2 x 2 design is meal type: whether the food is consumed at a meal or a snack. In experiment #2, the second factor is food type: fruit vs. vegetable. In experiment #3, the second factor is entree energy density: a regular energy density or a 40% greater energy density. In experiment #4, the second factor is plate size: a 6 inch plate vs. a 10 inch plate.
| Study group | Role | What they receive |
|---|---|---|
| Portion Size | Experimental | Each experiment manipulated food portion size of beverages, entrees, and side dishes Receives: Behavioral: Food portion size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intake of portion manipulated foods
Measured: In each experimental condition; 4 times in each 2 x 2 factorial experiment
Total energy consumed
Measured: In each experimental condition; 4 times in each 2 x 2 factorial experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startOct 2005
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EatingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer O Fisher, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436878
- Sponsor's protocol ID
- DK71095
- Other IDs
- R01DK071095
- Status last verified
- Jul 2018
- First submitted
- 16 Feb 2007
- Last updated
- 12 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intake Promoting Effects of Large Portions in Children
- ClinicalTrials.gov ID
- NCT00436878
- Acronym / sponsor ID
- DK71095
- Conditions
- Eating
- Keywords
- Eating Behavior, Children, Portion size, Experimental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2005
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 19 Feb 2007 (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 study is to test the effects of large food portions on children's eating. Experiment 1 will test the effect of portion size on children's consumption of sweetened beverages; we hypothesize that serving large beverage portions will increase the amount of energy children consume from this food. Experiment 2 will test the effects of portion size on children's intake of fruits and vegetables (FV) affect intake whether such effects are moderated by children's FV preferences and; we hypothesize that serving large fruit and vegetable portions will produce increases in children's intake of these foods, particularly for children who like fruit and vegetables. Experiment 3 will evaluate how food energy density affects children's response to large portions; we hypothesize that large portions will have the greatest influence on children's energy consumption when foods are energy dense. Experiment 4 will begin to address perceptual mechanisms by which large portions affect children's eating.
Detailed description
The emerging epidemic of overweight among underscores the need to identify contributing environmental factors. Marketplace trends for excessive and growing portion sizes in and outside the home have reinforced concerns that large portions may directly contribute by promoting excessive intake. To date, however, systematic investigation of portion size effects on children's eating has been extremely limited. Two laboratory studies have reported that serving large portions of macaroni and cheese to young children promoted energy consumption at meals. Whether portion size effects would be seen with other foods of varying energy content and preference is unknown. Of particular public health interest is whether serving large portions may affect children's intake of sweetened beverages, fruits and vegetables, and energy dense foods. This study will address these questions using an experimental approach to test the effects of portion size on children's eating.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Portion Size | Experimental | Behavioral: Food portion sizeEach experiment manipulated food portion size of beverages, entrees, and side dishes |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 5 to 6 years
Key exclusion criteria (3 listed)
- severe food allergies
- chronic illnesses or medication use affecting food intake
- dislike of foods on the menu
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 portion sizeEach of four experiments involves a 2 x 2 within-subjects factorial design, in which the first factor is the portion size of a food served to children: foods will be served in a reference amount (i.e. 250 g macaroni and cheese) or doubled in size(i.e. 500 g of macaroni and cheese). In the Experiment 1, the second factor of the 2 x 2 design is meal type: whether the food is consumed at a meal or a snack. In experiment #2, the second factor is food type: fruit vs. vegetable. In experiment #3, the second factor is entree energy density: a regular energy density or a 40% greater energy density. In experiment #4, the second factor is plate size: a 6 inch plate vs. a 10 inch plate. | Behavioural | Portion Size |
Primary outcome
Intake of portion manipulated foods
Time frame: In each experimental condition; 4 times in each 2 x 2 factorial experiment
Total energy consumed
Time frame: In each experimental condition; 4 times in each 2 x 2 factorial experiment
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 12 Jul 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.
Jennifer O Fisher, PhD principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food portion size in people with Eating, run by Temple University at 2 sites 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: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Intake of portion manipulated foods (time frame: In each experimental condition; 4 times in each 2 x 2 factorial experiment). 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 12 Jul 2018.