Feeding BehaviorNCT03242863
Effect of Varying Proportions of Low and High Energy Dense Foods Over 5 Days in Preschool Children
A study testing Food proportionality in people with Feeding Behavior, run by Penn State University at 1 site in United States.
Trial summary
In this study, the investigators will vary the proportions of high- and low-energy-dense foods served to preschool children at all meals and snacks during three 5-day periods. In the three experimental conditions, the same foods will be served; only the amounts and proportions of foods will be varied. 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 proportionality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2017to 2 May 2019
- 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 daycare centers
Who cannot join
- Food Allergies
- Food restrictions
- Health Issues that Preclude Participation
- Not available for duration of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory for the Study of Human Ingestive Behavior
University Park, Pennsylvania, 16802
About this study
Official title: Strategies to Moderate Energy Intake for the Prevention of Obesity in Children
In this study, the investigators will vary the proportions of high- and low-energy-dense foods served to preschool children at all meals and snacks during three 5-day periods. In the three experimental conditions, the same foods will be served; only the amounts and proportions of foods will be varied. In the Baseline condition, typical proportions of age-appropriate foods will be served. In the Addition condition, the portion sizes of low-energy-dense foods will be increased, and in the Substitution condition, the portions of low-energy-dense foods will be increased by replacing an equivalent amount of foods higher in energy density. The primary aim is to determine the effect on children's energy intake of varying the proportion of low- and high-energy-dense foods served, either by addition or substitution, over 5 days. It is hypothesized that children will consume less energy when they are served meals in which low-energy-dense foods are substituted for foods higher in energy density over 5 days and that children will consume more energy when served meals to which low-energy-dense foods are added. Additionally, we will test the hypothesis that daily energy intake in the three conditions will begin to converge across the 5-day period.
- Conditions
- Feeding Behavior
- Being tested
- Food proportionality
- 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 proportionalityOther
Proportions of high and low energy dense foods manipulated
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Baseline proportions of high and low energy dense foods. Receives: Other: Food proportionality |
| Addition | Experimental | Increased portion of low energy dense foods. Receives: Other: Food proportionality |
| Substitution | Experimental | Increased portion of low energy dense foods substituted for equal portion of foods higher in energy density. Receives: Other: Food proportionality |
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 in daily energy consumed of food and beverages, in kilocalories
Measured: Day 1-5 in weeks 1, 2, and 3
Differences in Food and Beverage Intake by Weight
Differences in daily weight consumed of food and beverages, in grams
Measured: Day 1-5 in weeks 1, 2, and 3
Differences in Food and Beverage Intake by Weight
Differences in daily weight consumed of vegetables and fruit, in grams
Measured: Day 1-5 in weeks 1, 2, and 3
Secondary outcomes (1)
Differences in Food and Beverage Intake by Energy Density
Differences in daily energy density consumed of food and beverages, in kilocalories/gram
Measured: Day 1-5 in weeks 1, 2, and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start27 Nov 2017
- Primary completion2 May 2019
- Study completion2 May 2019
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 (3)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
- 57 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, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242863
- Sponsor's protocol ID
- ChildFood503
- Other IDs
- R01DK082580
- Status last verified
- Oct 2020
- First submitted
- 3 Aug 2017
- Last updated
- 18 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rolls BJ, Roe LS, Keller KL. Children's Energy Intake Generally Increases in Response to the Energy Density of Meals but Varies with the Amounts and Types of Foods Served. Am J Clin Nutr. 2024 Jan;119(1):185-195. doi: 10.1016/j.ajcnut.2023.10.019. Epub 2023 Oct 27.
PubMed 37890673Roe 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 36965692Roe LS, Sanchez CE, Smethers AD, Keller KL, Rolls BJ. Portion size can be used strategically to increase intake of vegetables and fruits in young children over multiple days: a cluster-randomized crossover trial. Am J Clin Nutr. 2022 Jan 11;115(1):272-283. doi: 10.1093/ajcn/nqab321.
PubMed 34550306
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Moderate Energy Intake for the Prevention of Obesity in Children
- ClinicalTrials.gov ID
- NCT03242863
- Acronym / sponsor ID
- ChildFood503
- Conditions
- Feeding Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 8 Aug 2017 (actual)
- Results
- Posted 16 Jun 2020
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 will vary the proportions of high- and low-energy-dense foods served to preschool children at all meals and snacks during three 5-day periods. In the three experimental conditions, the same foods will be served; only the amounts and proportions of foods will be varied. In the Baseline condition, typical proportions of age-appropriate foods will be served. In the Addition condition, the portion sizes of low-energy-dense foods will be increased, and in the Substitution condition, the portions of low-energy-dense foods will be increased by replacing an equivalent amount of foods higher in energy density. The primary aim is to determine the effect on children's energy intake of varying the proportion of low- and high-energy-dense foods served, either by addition or substitution, over 5 days. It is hypothesized that children will consume less energy when they are served meals in which low-energy-dense foods are substituted for foods higher in energy density over 5 days and that children will consume more energy when served meals to which low-energy-dense foods are added. Additionally, we will test the hypothesis that daily energy intake in the three conditions will begin to converge across the 5-day period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: Food proportionalityBaseline proportions of high and low energy dense foods. |
| Addition | Experimental | Other: Food proportionalityIncreased portion of low energy dense foods. |
| Substitution | Experimental | Other: Food proportionalityIncreased portion of low energy dense foods substituted for equal portion of foods higher in energy density. |
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 daycare 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 proportionalityProportions of high and low energy dense foods manipulated | Other | Addition, Control, Substitution |
Primary outcome
Differences in Food and Beverage Intake by Energy
Time frame: Day 1-5 in weeks 1, 2, and 3
Differences in daily energy consumed of food and beverages, in kilocalories
Differences in Food and Beverage Intake by Weight
Time frame: Day 1-5 in weeks 1, 2, and 3
Differences in daily weight consumed of food and beverages, in grams
Differences in Food and Beverage Intake by Weight
Time frame: Day 1-5 in weeks 1, 2, and 3
Differences in daily weight consumed of vegetables and fruit, in grams
1 secondary outcome
Differences in Food and Beverage Intake by Energy Density
Time frame: Day 1-5 in weeks 1, 2, and 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37890673Rolls BJ, Roe LS, Keller KL. Children's Energy Intake Generally Increases in Response to the Energy Density of Meals but Varies with the Amounts and Types of Foods Served. Am J Clin Nutr. 2024 Jan;119(1):185-195. doi: 10.1016/j.ajcnut.2023.10.019. Epub 2023 Oct 27.
- 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.
- Derived from this study: PubMed 34550306Roe LS, Sanchez CE, Smethers AD, Keller KL, Rolls BJ. Portion size can be used strategically to increase intake of vegetables and fruits in young children over multiple days: a cluster-randomized crossover trial. Am J Clin Nutr. 2022 Jan 11;115(1):272-283. doi: 10.1093/ajcn/nqab321.
Related trials for Feeding Behavior
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Not yet recruiting
Effects of Environmental Comfort and Oral Motor Stimulation on Comfort and Oral Feeding Readiness in Preterm Infants
Prematurity, Feeding Behaviors
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
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, PhD principal investigator
Penn 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 Food proportionality in people with Feeding 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 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 18 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 16 Jun 2020). 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: Day 1-5 in weeks 1, 2, and 3). The study lists 3 primary outcomes in all. 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 NCT03242863, which also lists 3 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 18 Nov 2020.