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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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The aim of the study is to determine the effect of varying both the palatability and portion size of vegetables served to preschool children at a meal on the outcomes of food and energy intake at the meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Palatability and Standard Portion Size | Experimental | Vegetables with Standard Palatability and Standard Portion Size |
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| Standard Palatability and Larger Portion Size | Experimental | Vegetables with Standard Palatability and Larger Portion Size |
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| Enhanced Palatability and Standard Portion Size | Experimental | Vegetables with Enhanced Palatability and Standard Portion Size |
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| Enhanced Palatability and Larger Portion Size | Experimental | Vegetables with Enhanced Palatability and Larger Portion Size |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plain Vegetables Served in 100% Portion Size | Other | Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between Interventions in Vegetable Intake | Weight of vegetables consumed at the meal (grams) | One meal per week for each intervention (Study weeks 1, 2, 3, and 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between Interventions in Food Intake | Weight of food (including milk) consumed at the meal (grams) | One meal per week for each intervention (Study weeks 1, 2, 3, and 4) |
| Difference Between Interventions in Meal Energy Intake |
| Measure | Description | Time Frame |
|---|---|---|
| Preference of Vegetables Served at the Meal | Preferred version of vegetables (1=standard palatability, 2=enhanced palatability) | Study week 5 |
| Liking of All Foods Served at the Meal | The Yummy-Yucky Cartoon Faces Scale (1=Yucky, 2=Just Okay, and 3=Yummy) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University | University Park | Pennsylvania | 16802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33836215 | Derived | Diktas HE, Roe LS, Keller KL, Sanchez CE, Rolls BJ. Promoting vegetable intake in preschool children: Independent and combined effects of portion size and flavor enhancement. Appetite. 2021 Sep 1;164:105250. doi: 10.1016/j.appet.2021.105250. Epub 2021 Apr 6. |
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Children aged 3 to 5 years old were recruited from classrooms at three childcare centers in State College, Pennsylvania by distributing letters to parents between May 2019 and October 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | St Pal/Lg PS, En Pal/St PS, St Pal/St PS, En Pal/Lg PS | Participants who received the meals in the order of Plain Vegetables served in 200% Portion Size first, then Enhanced Vegetables served in 100% Portion Size, then Plain Vegetables served in 100% Portion Size, then Enhanced Vegetables served in 200% Portion Size |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study Week 1 |
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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 | Feb 26, 2020 |
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| Plain Vegetables Served in 200% Portion Size | Other | Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables |
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| Enhanced Vegetables Served in 100% Portion Size | Other | Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables |
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| Enhanced Vegetables Served in 200% Portion Size | Other | Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables |
|
Energy consumed at the meal (kilocalories)
| One meal per week for each intervention (Study weeks 1, 2, 3, and 4) |
| Difference Between Interventions in Meal Energy Density | Energy density of the food consumed at the meal (kilocalories/gram) | One meal per week for each intervention (Study weeks 1, 2, 3, and 4) |
| Study week 5 |
| Ranking of All Foods Served at the Meal | Ranking of all foods in order of preference (1= most preferred, 2= next most preferred, etc.) | Study week 5 |
| En Pal/Lg PS, St Pal/St PS, En Pal/St PS, St Pal/Lg PS |
Participants who received the meals in the order of Enhanced Vegetables served in 200% Portion Size first, then Plain Vegetables served in 100% Portion Size, then Enhanced Vegetables served in 100% Portion Size, then Plain Vegetables served in 200% Portion Size |
| FG002 | En Pal/St PS, En Pal/Lg PS, St Pal/Lg PS, St Pal/St PS | Participants who received the meals in the order of Enhanced Vegetables served in 100% Portion Size first, then Enhanced Vegetables served in 200% Portion Size, then Plain Vegetables served in 200% Portion Size, then Plain Vegetables served in 100% Portion Size |
| FG003 | St Pal/St PS, St Pal/Lg PS, En Pal/Lg PS, En Pal/St PS | Participants who received the meals in the order of Plain Vegetables served in 100% Portion Size first, then Plain Vegetables served in 200% Portion Size, then Enhanced Vegetables served in 200% Portion Size, then Enhanced Vegetables served in 100% Portion Size |
| FG004 | En Pal/Lg PS, St Pal/Lg PS, En Pal/St PS, St Pal/St PS | Participants who received the meals in the order of Enhanced Vegetables served in 200% Portion Size first, then Plain Vegetables served in 200% Portion Size, then Enhanced Vegetables served in 100% Portion Size, then Plain Vegetables served in 100% Portion Size |
| COMPLETED |
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| NOT COMPLETED |
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| Study Week 2 |
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| Study Week 3 |
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| Study Week 4 |
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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 | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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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 | Count of Participants | Participants |
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| 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 | Difference Between Interventions in Vegetable Intake | Weight of vegetables consumed at the meal (grams) | Posted | Mean | Standard Error | grams | One meal per week for each intervention (Study weeks 1, 2, 3, and 4) |
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| Secondary | Difference Between Interventions in Food Intake | Weight of food (including milk) consumed at the meal (grams) | Posted | Mean | Standard Error | grams | One meal per week for each intervention (Study weeks 1, 2, 3, and 4) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Difference Between Interventions in Meal Energy Intake | Energy consumed at the meal (kilocalories) | Posted | Mean | Standard Error | kilocalories | One meal per week for each intervention (Study weeks 1, 2, 3, and 4) |
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| Secondary | Difference Between Interventions in Meal Energy Density | Energy density of the food consumed at the meal (kilocalories/gram) | Posted | Mean | Standard Error | kilocalories/gram | One meal per week for each intervention (Study weeks 1, 2, 3, and 4) |
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| Other Pre-specified | Preference of Vegetables Served at the Meal | Preferred version of vegetables (1=standard palatability, 2=enhanced palatability) | Not Posted | Study week 5 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Liking of All Foods Served at the Meal | The Yummy-Yucky Cartoon Faces Scale (1=Yucky, 2=Just Okay, and 3=Yummy) | Not Posted | Study week 5 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Ranking of All Foods Served at the Meal | Ranking of all foods in order of preference (1= most preferred, 2= next most preferred, etc.) | Not Posted | Study week 5 | Participants |
5 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 | Standard Palatability and Standard Portion Size | Vegetables with Standard Palatability and Standard Portion Size Plain Vegetables Served in 100% Portion Size: Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables | 0 | 67 | 0 | 67 | 0 | 67 |
| EG001 | Standard Palatability and Larger Portion Size | Vegetables with Standard Palatability and Larger Portion Size Plain Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables | 0 | 67 | 0 | 67 | 0 | 67 |
| EG002 | Enhanced Palatability and Standard Portion Size | Vegetables with Enhanced Palatability and Standard Portion Size Enhanced Vegetables Served in 100% Portion Size: Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables | 0 | 67 | 0 | 67 | 0 | 67 |
| EG003 | Enhanced Palatability and Larger Portion Size | Vegetables with Enhanced Palatability and Larger Portion Size Enhanced Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables | 0 | 67 | 0 | 67 | 0 | 67 |
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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 |
| Aug 18, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 26, 2020 | Sep 4, 2020 | ICF_001.pdf |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D064787 | Portion Size |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)
| Mixed Models Analysis |
| <0.0001 |
| Superiority |
| Interaction between Portion Size and Palatability | Mixed Models Analysis | 0.0992 | Superiority |
Vegetables with Enhanced Palatability and Larger Portion Size Enhanced Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables |
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Vegetables with Enhanced Palatability and Larger Portion Size Enhanced Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables |
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Vegetables with Enhanced Palatability and Larger Portion Size Enhanced Vegetables Served in 200% Portion Size: Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables |
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