Trial Outcomes & Findings for Variations in Palatability and Portion Size of Vegetables on Meal Intake of Preschool Children (NCT NCT03926065)
NCT ID: NCT03926065
Last Updated: 2020-09-25
Results Overview
Weight of vegetables consumed at the meal (grams)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
Results posted on
2020-09-25
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
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
|
|---|---|---|---|---|---|
|
Study Week 1
STARTED
|
11
|
9
|
14
|
18
|
15
|
|
Study Week 1
COMPLETED
|
11
|
9
|
14
|
18
|
15
|
|
Study Week 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Study Week 2
STARTED
|
11
|
9
|
14
|
18
|
15
|
|
Study Week 2
COMPLETED
|
11
|
9
|
14
|
18
|
15
|
|
Study Week 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Study Week 3
STARTED
|
11
|
9
|
14
|
18
|
15
|
|
Study Week 3
COMPLETED
|
11
|
9
|
14
|
18
|
15
|
|
Study Week 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Study Week 4
STARTED
|
11
|
9
|
14
|
18
|
15
|
|
Study Week 4
COMPLETED
|
11
|
9
|
14
|
18
|
15
|
|
Study Week 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Variations in Palatability and Portion Size of Vegetables on Meal Intake of Preschool Children
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=67 Participants
Enrolled participants who completed the study
|
|---|---|
|
Age, Continuous
|
4.2 years
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)Weight of vegetables consumed at the meal (grams)
Outcome measures
| Measure |
Standard Palatability and Standard Portion Size
n=67 Participants
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
|
Standard Palatability and Larger Portion Size
n=67 Participants
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
|
Enhanced Palatability and Standard Portion Size
n=67 Participants
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
|
Enhanced Palatability and Larger Portion Size
n=67 Participants
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
|
|---|---|---|---|---|
|
Difference Between Interventions in Vegetable Intake
|
32 grams
Standard Error 3
|
57 grams
Standard Error 5
|
31 grams
Standard Error 3
|
50 grams
Standard Error 4
|
SECONDARY outcome
Timeframe: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)Weight of food (including milk) consumed at the meal (grams)
Outcome measures
| Measure |
Standard Palatability and Standard Portion Size
n=67 Participants
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
|
Standard Palatability and Larger Portion Size
n=67 Participants
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
|
Enhanced Palatability and Standard Portion Size
n=67 Participants
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
|
Enhanced Palatability and Larger Portion Size
n=67 Participants
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
|
|---|---|---|---|---|
|
Difference Between Interventions in Food Intake
|
283 grams
Standard Error 10
|
302 grams
Standard Error 12
|
287 grams
Standard Error 10
|
305 grams
Standard Error 12
|
SECONDARY outcome
Timeframe: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)Energy consumed at the meal (kilocalories)
Outcome measures
| Measure |
Standard Palatability and Standard Portion Size
n=67 Participants
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
|
Standard Palatability and Larger Portion Size
n=67 Participants
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
|
Enhanced Palatability and Standard Portion Size
n=67 Participants
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
|
Enhanced Palatability and Larger Portion Size
n=67 Participants
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
|
|---|---|---|---|---|
|
Difference Between Interventions in Meal Energy Intake
|
262 kilocalories
Standard Error 10
|
282 kilocalories
Standard Error 10
|
277 kilocalories
Standard Error 8
|
284 kilocalories
Standard Error 11
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Standard Palatability and Standard Portion Size
n=67 Participants
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
|
Standard Palatability and Larger Portion Size
n=67 Participants
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
|
Enhanced Palatability and Standard Portion Size
n=67 Participants
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
|
Enhanced Palatability and Larger Portion Size
n=67 Participants
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
|
|---|---|---|---|---|
|
Difference Between Interventions in Meal Energy Density
|
1.41 kilocalories/gram
Standard Error 0.03
|
1.35 kilocalories/gram
Standard Error 0.03
|
1.48 kilocalories/gram
Standard Error 0.03
|
1.40 kilocalories/gram
Standard Error 0.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Study week 5Preferred version of vegetables (1=standard palatability, 2=enhanced palatability)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Study week 5The Yummy-Yucky Cartoon Faces Scale (1=Yucky, 2=Just Okay, and 3=Yummy)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Study week 5Ranking of all foods in order of preference (1= most preferred, 2= next most preferred, etc.)
Outcome measures
Outcome data not reported
Adverse Events
Standard Palatability and Standard Portion Size
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Palatability and Larger Portion Size
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Palatability and Standard Portion Size
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Palatability and Larger Portion Size
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Barbara J. Rolls
Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University
Phone: 814-863-8481
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place