Feeding Behavior
Conditions
Brief summary
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.
Interventions
OTHERPlain Vegetables Served in 100% Portion Size
Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables
OTHERPlain Vegetables Served in 200% Portion Size
Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables
OTHEREnhanced Vegetables Served in 100% Portion Size
Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables
OTHEREnhanced Vegetables Served in 200% Portion Size
Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* Children who are enrolled in a scheduled classroom of the designated childcare centers
Exclusion criteria
* Children who are allergic to any of the foods served * Children whose diets exclude any of the foods served * Children who will not be present at the childcare center for all of the scheduled study days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Interventions in Vegetable Intake | One meal per week for each intervention (Study weeks 1, 2, 3, and 4) | Weight of vegetables consumed at the meal (grams) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Interventions in Food Intake | One meal per week for each intervention (Study weeks 1, 2, 3, and 4) | Weight of food (including milk) consumed at the meal (grams) |
| Difference Between Interventions in Meal Energy Intake | One meal per week for each intervention (Study weeks 1, 2, 3, and 4) | Energy consumed at the meal (kilocalories) |
| Difference Between Interventions in Meal Energy Density | One meal per week for each intervention (Study weeks 1, 2, 3, and 4) | Energy density of the food consumed at the meal (kilocalories/gram) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Liking of All Foods Served at the Meal | Study week 5 | The Yummy-Yucky Cartoon Faces Scale (1=Yucky, 2=Just Okay, and 3=Yummy) |
| Ranking of All Foods Served at the Meal | Study week 5 | Ranking of all foods in order of preference (1= most preferred, 2= next most preferred, etc.) |
| Preference of Vegetables Served at the Meal | Study week 5 | Preferred version of vegetables (1=standard palatability, 2=enhanced palatability) |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Enrolled participants who completed the study | 67 |
| Total | 67 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 4.2 years STANDARD_DEVIATION 0.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 51 Participants |
| Region of Enrollment United States | 67 Participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 67 | 0 / 67 | 0 / 67 |
| other Total, other adverse events | 0 / 67 | 0 / 67 | 0 / 67 | 0 / 67 |
| serious Total, serious adverse events | 0 / 67 | 0 / 67 | 0 / 67 | 0 / 67 |
Outcome results
Primary
Difference Between Interventions in Vegetable Intake
Weight of vegetables consumed at the meal (grams)
Time frame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Palatability and Standard Portion Size | Difference Between Interventions in Vegetable Intake | 32 grams | Standard Error 3 |
| Standard Palatability and Larger Portion Size | Difference Between Interventions in Vegetable Intake | 57 grams | Standard Error 5 |
| Enhanced Palatability and Standard Portion Size | Difference Between Interventions in Vegetable Intake | 31 grams | Standard Error 3 |
| Enhanced Palatability and Larger Portion Size | Difference Between Interventions in Vegetable Intake | 50 grams | Standard Error 4 |
Comparison: Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)p-value: 0.126Mixed Models Analysis
Comparison: Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)p-value: <0.0001Mixed Models Analysis
Comparison: Interaction between Portion Size and Palatabilityp-value: 0.0992Mixed Models Analysis
Secondary
Difference Between Interventions in Food Intake
Weight of food (including milk) consumed at the meal (grams)
Time frame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Palatability and Standard Portion Size | Difference Between Interventions in Food Intake | 283 grams | Standard Error 10 |
| Standard Palatability and Larger Portion Size | Difference Between Interventions in Food Intake | 302 grams | Standard Error 12 |
| Enhanced Palatability and Standard Portion Size | Difference Between Interventions in Food Intake | 287 grams | Standard Error 10 |
| Enhanced Palatability and Larger Portion Size | Difference Between Interventions in Food Intake | 305 grams | Standard Error 12 |
Comparison: Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)p-value: 0.5502Mixed Models Analysis
Comparison: Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)p-value: 0.0072Mixed Models Analysis
Secondary
Difference Between Interventions in Meal Energy Density
Energy density of the food consumed at the meal (kilocalories/gram)
Time frame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Palatability and Standard Portion Size | Difference Between Interventions in Meal Energy Density | 1.41 kilocalories/gram | Standard Error 0.03 |
| Standard Palatability and Larger Portion Size | Difference Between Interventions in Meal Energy Density | 1.35 kilocalories/gram | Standard Error 0.03 |
| Enhanced Palatability and Standard Portion Size | Difference Between Interventions in Meal Energy Density | 1.48 kilocalories/gram | Standard Error 0.03 |
| Enhanced Palatability and Larger Portion Size | Difference Between Interventions in Meal Energy Density | 1.40 kilocalories/gram | Standard Error 0.03 |
Comparison: Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)p-value: 0.0012Mixed Models Analysis
Comparison: Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)p-value: <0.0001Mixed Models Analysis
Secondary
Difference Between Interventions in Meal Energy Intake
Energy consumed at the meal (kilocalories)
Time frame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Palatability and Standard Portion Size | Difference Between Interventions in Meal Energy Intake | 262 kilocalories | Standard Error 10 |
| Standard Palatability and Larger Portion Size | Difference Between Interventions in Meal Energy Intake | 282 kilocalories | Standard Error 10 |
| Enhanced Palatability and Standard Portion Size | Difference Between Interventions in Meal Energy Intake | 277 kilocalories | Standard Error 8 |
| Enhanced Palatability and Larger Portion Size | Difference Between Interventions in Meal Energy Intake | 284 kilocalories | Standard Error 11 |
Comparison: Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)p-value: 0.103Mixed Models Analysis
Comparison: Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)p-value: 0.0178Mixed Models Analysis
Comparison: Interaction between Portion Size and Palatabilityp-value: 0.241Mixed Models Analysis
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)
Time frame: Study week 5
Other Pre-specified
Preference of Vegetables Served at the Meal
Preferred version of vegetables (1=standard palatability, 2=enhanced palatability)
Time frame: Study week 5
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.)
Time frame: Study week 5