Eating BehaviorNCT04971811
Effects of Energy Density on Self-served Snacks in Preschool Children
A study testing Snack with energy density less than 1.5 kcal/g and Snack with energy density greater than 1.5 kcal/g in people with Eating Behavior, run by Penn State University at 1 site in United States.
Trial summary
The purpose of the study is to determine whether the energy density of snack foods affects the amounts that preschool children serve themselves and then consume. We will serve snacks that vary in energy density to preschool children in their childcare centers and measure the amount they serve themselves and consume. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Eating Behavior
- What is being tested?
- Snack with energy density less than 1.5 kcal/g and Snack with energy density greater than 1.5 kcal/g
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 3 Mar 2022
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who are enrolled in a scheduled classroom of the participating childcare centers
- Children who are between the ages of 4 and 6 years old at the time of enrollment
Who cannot join
- Children who have tested positive or are showing symptoms of COVID-19, or have recently had potential exposure with a person with COVID-19
- Children who are allergic to any of the foods served
- Children whose diets exclude any of the foods served
- Children who are absent from the childcare center on the acclimation day or both study days
- Children who are not able to serve themselves the two foods that are provided during the acclimation day
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Self-served Snack Study for Preschool Children
The purpose of the study is to determine whether the energy density of snack foods affects the amounts that preschool children serve themselves and then consume. We will serve snacks that vary in energy density to preschool children in their childcare centers and measure the amount they serve themselves and consume. The results will have implications for guidance about the provision of snacks for preschool children and may help in identifying strategies for the prevention of obesity in children.
- Conditions
- Eating Behavior
- Being tested
- Snack with energy density less than 1.5 kcal/g, Snack with energy density greater than 1.5 kcal/g
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snack with energy density less than 1.5 kcal/gOther
Snack meal with snack food having energy density less than 1.5 kcal/g
Snack with energy density greater than 1.5 kcal/gOther
Snack meal with snack food having energy density greater than 1.5 kcal/g
| Study group | Role | What they receive |
|---|---|---|
| Lower-energy-dense Snack | Experimental | Test snack with lower-energy-dense snack food Receives: Other: Snack with energy density less than 1.5 kcal/g |
| Higher-energy-dense Snack | Experimental | Test snack with higher-energy-dense snack food Receives: Other: Snack with energy density greater than 1.5 kcal/g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between interventions in the weight of self-served snack food
Weight served of snack food in grams
Measured: Study weeks 1 and 2
Difference between interventions in the weight of snack food consumed
Weight consumed of snack food in grams
Measured: Study weeks 1 and 2
Secondary outcomes (4)
Difference between interventions in the volume of self-served snack food
Volume served of snack food in milliliters (ml)
Measured: Study weeks 1 and 2
Difference between interventions in the volume of snack food consumed
Volume consumed of snack food in milliliters (ml)
Measured: Study weeks 1 and 2
Difference between interventions in the energy of self-served snack food
Energy served of snack food in kilocalories (kcal)
Measured: Study weeks 1 and 2
Difference between interventions in the energy of snack food consumed
Energy consumed of snack food in kilocalories (kcal)
Measured: Study weeks 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 posted22 Jul 2021
- Study start15 Sep 2021
- Primary completion24 Feb 2022
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating 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
- None (open label)
- Enrolment
- 55 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971811
- Sponsor's protocol ID
- ChildFood601
- Status last verified
- Mar 2022
- First submitted
- 20 Jul 2021
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-served Snack Study for Preschool Children
- ClinicalTrials.gov ID
- NCT04971811
- Acronym / sponsor ID
- ChildFood601
- Conditions
- Eating Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- 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 the study is to determine whether the energy density of snack foods affects the amounts that preschool children serve themselves and then consume. We will serve snacks that vary in energy density to preschool children in their childcare centers and measure the amount they serve themselves and consume. The results will have implications for guidance about the provision of snacks for preschool children and may help in identifying strategies for the prevention of obesity in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower-energy-dense Snack | Experimental | Other: Snack with energy density less than 1.5 kcal/gTest snack with lower-energy-dense snack food |
| Higher-energy-dense Snack | Experimental | Other: Snack with energy density greater than 1.5 kcal/gTest snack with higher-energy-dense snack food |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children who are enrolled in a scheduled classroom of the participating childcare centers
- Children who are between the ages of 4 and 6 years old at the time of enrollment
Key exclusion criteria (5 listed)
- Children who have tested positive or are showing symptoms of COVID-19, or have recently had potential exposure with a person with COVID-19
- Children who are allergic to any of the foods served
- Children whose diets exclude any of the foods served
- Children who are absent from the childcare center on the acclimation day or both study days
- Children who are not able to serve themselves the two foods that are provided during the acclimation day
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 |
|---|---|---|
| Snack with energy density less than 1.5 kcal/gSnack meal with snack food having energy density less than 1.5 kcal/g | Other | Lower-energy-dense Snack |
| Snack with energy density greater than 1.5 kcal/gSnack meal with snack food having energy density greater than 1.5 kcal/g | Other | Higher-energy-dense Snack |
Primary outcome
Difference between interventions in the weight of self-served snack food
Time frame: Study weeks 1 and 2
Weight served of snack food in grams
Difference between interventions in the weight of snack food consumed
Time frame: Study weeks 1 and 2
Weight consumed of snack food in grams
4 secondary outcomes
Difference between interventions in the volume of self-served snack food
Time frame: Study weeks 1 and 2
Difference between interventions in the volume of snack food consumed
Time frame: Study weeks 1 and 2
Difference between interventions in the energy of self-served snack food
Time frame: Study weeks 1 and 2
Difference between interventions in the energy of snack food consumed
Time frame: Study weeks 1 and 2
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 2022.
- Individual participant dataSharing planned: No
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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 Snack with energy density less than 1.5 kcal/g and Snack with energy density greater than 1.5 kcal/g in people with Eating 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 2 inclusion and 5 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 2022. 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 interventions in the weight of self-served snack food (time frame: Study weeks 1 and 2). 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 2022.