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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK082580 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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In this study, the investigators will vary the energy density of foods served during three 5-day periods. There will be a baseline condition, and then a condition where the energy density of food is lower and a condition where the energy density of food is higher. The primary aim is to determine the effect of varying the energy density of foods served over 5 days on energy intake in preschool children. It is hypothesized that mean daily energy intake will be greater when children are served higher energy dense foods over 5 days than when served lower energy dense foods over the same period. Additionally, it is hypothesized that daily energy intake in the conditions with higher and lower energy densities will begin to converge across the 5-day period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100% Food Energy Density | Experimental | Baseline Food Energy Density |
|
| 80% Food Energy Density | Experimental | Lower Food Energy Density |
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| 120% Food Energy Density | Experimental | Higher Food Energy Density |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food Energy Density | Other | Food Energy density manipulated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Food and Beverage Intake by Energy | Differences in daily intake of food and beverages by energy, in kcal | Days 1-5 in Weeks 1, 2, and 3 |
| Differences in Food and Beverage Intake by Weight | Differences in daily intake of food and beverages by weight, in grams | Days 1-5 in weeks 1, 2, and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Food and Beverage Intake by Energy Density | Differences in daily intake of food and beverages by energy density, in kcal/g | Days 1-5 in weeks 1, 2, and 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara J Rolls | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory for the Study of Human Ingestive Behavior | University Park | Pennsylvania | 16802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37890673 | Derived | 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. | |
| 36965692 | Derived | Roe 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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Children aged 3 to 5 years old were recruited from classrooms at three childcare centers in State College, PA by distributing letters to parents between September 2016 and September 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | 80% Food Energy Density First, Then 100%, Then 120% | Participants in the classroom that received the three food energy density interventions across the three periods in the order of 80%, then 100%, then 120%. |
| FG001 | 100% Food Energy Density First, Then 120%, Then 80% | Participants in the classroom that received the three food energy density interventions across the three periods in the order of 100%, then 120%, then 80%. |
| FG002 | 120% Food Energy Density First, Then 80%, Then 100% | Participants in the classroom that received the three food energy density interventions across the three periods in the order of 120%, then 80%, then 100%. |
| FG003 | 80% Food Energy Density First, Then 120%, Then 100% | Participants in the classroom that received the three food energy density interventions across the three periods in the order of 80%, then 120%, then 100%. |
| FG004 | 100% Food Energy Density, Then 80%, Then 120% | Participants in the classroom that received the three food energy density interventions across the three periods in the order of 100%, then 80%, then 120%. |
| FG005 | 120% Food Energy Density, Then 100%, Then 80% | Participants in the classroom that received the three food energy density interventions across the three periods in the order of 120%, then 100%, then 80%. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Week 1 |
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| Study Week 2 |
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| Study Week 3 |
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The data of one participant was excluded from analysis due to absence from meals on three or more days of each 5-day study period.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Enrolled participants who completed the trial and whose data was not excluded from analysis |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Differences in Food and Beverage Intake by Energy | Differences in daily intake of food and beverages by energy, in kcal | Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods. | Posted | Mean | Standard Error | kilocalories | Days 1-5 in Weeks 1, 2, and 3 |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 80% Food Energy Density | All participants during the 80% Food Energy Density intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara J. Rolls | Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University | 814-863-8481 | bjr4@psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2018 | May 17, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG002 |
| 120% Food Energy Density |
Higher Food Energy Density Food Energy Density: Food Energy density manipulated |
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|
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| Primary | Differences in Food and Beverage Intake by Weight | Differences in daily intake of food and beverages by weight, in grams | Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods. | Posted | Mean | Standard Error | grams | Days 1-5 in weeks 1, 2, and 3 |
|
|
|
|
| Secondary | Differences in Food and Beverage Intake by Energy Density | Differences in daily intake of food and beverages by energy density, in kcal/g | Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods. | Posted | Mean | Standard Error | kilocalories/gram | Days 1-5 in weeks 1, 2, and 3 |
|
|
|
|
| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | 100% Food Energy Density | All participants during the 100% Food Energy Density intervention | 0 | 56 | 0 | 56 | 0 | 56 |
| EG002 | 120% Food Energy Density | All participants during the 120% Food Energy Density intervention | 0 | 56 | 0 | 56 | 0 | 56 |
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| 0.15 |
According to predefined comparisons, intake by weight in the 120% intervention was compared to the 100% intervention. |
| Superiority |