Feeding BehaviorNCT02963987
Effect of Portion Size Over 5 Days in Preschool Children
A study testing Food and Beverage Portion Size in people with Feeding Behavior, run by Penn State University at 2 sites in United States.
Trial summary
In this study, the investigators varied the portion size of all meals served during two 5-day periods. During one period, baseline amounts of all foods and beverages were served, and during the other, the portion size of all items was increased by 50%. 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 and Beverage Portion Size
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2015to Apr 2016
- 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 childcare centers
Who cannot join
- Food Allergies
- Food Restrictions
- Health Issues that Preclude Participation
- Not available for duration of the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Laboratory for the Study of Human Ingestive Behavior
University Park, Pennsylvania, 16802
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 the portion size of all meals served during two 5-day periods. During one period, baseline amounts of all foods and beverages were served, and during the other, the portion size of all items was increased by 50%. The primary aim of the study is to determine the effect of varying the portion size of foods and beverages served over 5 days on energy intake in preschool children.
- Conditions
- Feeding Behavior
- Being tested
- Food and Beverage 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.
Food and Beverage Portion SizeOther
Variations of Food and Beverage Portion Size (100% Baseline portions and increased 50% for 150% portions)
| Study group | Role | What they receive |
|---|---|---|
| 100% Portion Size | Experimental | 100% Food and Beverage Portion Size Receives: Other: Food and Beverage Portion Size |
| 150% Portion Size | Experimental | 150% Food and Beverage Portion Size Receives: Other: Food and Beverage Portion Size |
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 between 100% and 150% portion size conditions in energy intake (kcal) determined from weighed intakes of food and beverages
Measured: Days 1-5 in Periods 1 and 2
Secondary outcomes (2)
Differences in Food and Beverage Intake by Energy Density
Differences between 100% and 150% portion size conditions in daily energy density (kcal/g) determined from weighed intakes of food and beverages
Measured: Days 1-5 in Periods 1 and 2
Differences in Food and Beverage Intake by Weight
Differences between 100% and 150% portion size conditions in daily weighed intake of food and beverages (g)
Measured: Days 1-5 in Periods 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startJun 2015
- Primary completionApr 2016
- Study completionApr 2016
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Barbara J. Rolls, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963987
- Sponsor's protocol ID
- ChildFood501
- Other IDs
- R01DK082580, 2011-67001-30117
- Status last verified
- May 2019
- First submitted
- 10 Nov 2016
- Last updated
- 11 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Smethers AD, Roe LS, Sanchez CE, Zuraikat FM, Keller KL, Kling SMR, Rolls BJ. Portion size has sustained effects over 5 days in preschool children: a randomized trial. Am J Clin Nutr. 2019 May 1;109(5):1361-1372. doi: 10.1093/ajcn/nqy383.
PubMed 30976782Roe 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 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Portion Size Over 5 Days in Preschool Children
- ClinicalTrials.gov ID
- NCT02963987
- Acronym / sponsor ID
- ChildFood501
- Conditions
- Feeding Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), United States Department of Agriculture (USDA)
- Study start
- Jun 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Posted 29 May 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 varied the portion size of all meals served during two 5-day periods. During one period, baseline amounts of all foods and beverages were served, and during the other, the portion size of all items was increased by 50%. The primary aim of the study is to determine the effect of varying the portion size of foods and beverages served over 5 days on energy intake in preschool children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100% Portion Size | Experimental | Other: Food and Beverage Portion Size100% Food and Beverage Portion Size |
| 150% Portion Size | Experimental | Other: Food and Beverage Portion Size150% Food and Beverage Portion Size |
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 childcare 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 and Beverage Portion SizeVariations of Food and Beverage Portion Size (100% Baseline portions and increased 50% for 150% portions) | Other | 100% Portion Size, 150% Portion Size |
Primary outcome
Differences in Food and Beverage Intake by Energy
Time frame: Days 1-5 in Periods 1 and 2
Differences between 100% and 150% portion size conditions in energy intake (kcal) determined from weighed intakes of food and beverages
2 secondary outcomes
Differences in Food and Beverage Intake by Energy Density
Time frame: Days 1-5 in Periods 1 and 2
Differences in Food and Beverage Intake by Weight
Time frame: Days 1-5 in Periods 1 and 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30976782Smethers AD, Roe LS, Sanchez CE, Zuraikat FM, Keller KL, Kling SMR, Rolls BJ. Portion size has sustained effects over 5 days in preschool children: a randomized trial. Am J Clin Nutr. 2019 May 1;109(5):1361-1372. doi: 10.1093/ajcn/nqy383.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Beverage Portion Size in people with Feeding Behavior, run by Penn State 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 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 Jun 2019. 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?
Yes. Results are posted in the registry (first posted 29 May 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 Periods 1 and 2). 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 NCT02963987, 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 Jun 2019.