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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | Baseline proportions of high and low energy dense foods. |
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| Addition | Experimental | Increased portion of low energy dense foods. |
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| Substitution | Experimental | Increased portion of low energy dense foods substituted for equal portion of foods higher in energy density. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food proportionality | Other | Proportions of high and low energy dense foods manipulated |
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| Measure | Description | Time Frame |
|---|---|---|
| Differences in Food and Beverage Intake by Energy | Differences in daily energy consumed of food and beverages, in kilocalories | 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 | 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 | Day 1-5 in weeks 1, 2, and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Food and Beverage Intake by Energy Density | Differences in daily energy density consumed of food and beverages, in kilocalories/gram | Day 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, PhD | 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 were recruited from three childcare centers in central Pennsylvania between November 2017 and March 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | Con First, Then Add, Then Sub | Participants in the classrooms that received the three food proportionality interventions across the three periods in the order of Control, then Addition, then Substitution. |
| FG001 | Add First, Then Sub, Then Con | Participants in the classrooms that received the three food proportionality interventions across the three periods in the order of Addition, then Substitution, then Control. |
| FG002 | Sub First, Then Con, Then Add | Participants in the classroom that received the three food proportionality interventions across the three periods in the order of Substitution, then Control, then Addition. |
| FG003 | Con First, Then Sub, Then Add | Participants in the classroom that received the three food proportionality interventions across the three periods in the order of Control, then Substitution, then Addition. |
| FG004 | Add First, Then Con, Then Sub | Participants in the classroom that received the three food proportionality interventions across the three periods in the order of Addition, then Control, then Substitution. |
| FG005 | Sub First, Then Add, Then Con | Participants in the classroom that received the three food proportionality interventions across the three periods in the order of Substitution, then Addition, then Control. |
| 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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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Enrolled participants who completed the study |
| 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 energy consumed of food and beverages, in kilocalories | Posted | Mean | Standard Error | kilocalories per day | Day 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 | Control | All participants during the Control condition | 0 |
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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 |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 18, 2019 | May 29, 2020 | ICF_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2018 | Oct 31, 2020 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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| 34550306 | Derived | Roe 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. |
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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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| Primary | Differences in Food and Beverage Intake by Weight | Differences in daily weight consumed of food and beverages, in grams | Posted | Mean | Standard Error | grams per day | Day 1-5 in weeks 1, 2, and 3 |
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| Primary | Differences in Food and Beverage Intake by Weight | Differences in daily weight consumed of vegetables and fruit, in grams | Posted | Mean | Standard Error | grams per day | Day 1-5 in weeks 1, 2, and 3 |
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| Secondary | Differences in Food and Beverage Intake by Energy Density | Differences in daily energy density consumed of food and beverages, in kilocalories/gram | Posted | Mean | Standard Error | kilocalories/gram per day | Day 1-5 in weeks 1, 2, and 3 |
|
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| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | Addition | All participants during the Addition condition | 0 | 57 | 0 | 57 | 0 | 57 |
| EG002 | Substitution | All participants during the Substitution condition | 0 | 57 | 0 | 57 | 0 | 57 |
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