Trial Outcomes & Findings for Effect of Energy Density Over 5 Days in Preschool Children (NCT NCT03010501)
NCT ID: NCT03010501
Last Updated: 2019-07-11
Results Overview
Differences in daily intake of food and beverages by energy, in kcal
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
Days 1-5 in Weeks 1, 2, and 3
Results posted on
2019-07-11
Participant Flow
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.
Participant milestones
| Measure |
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%.
|
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%.
|
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%.
|
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%.
|
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%.
|
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%.
|
|---|---|---|---|---|---|---|
|
Study Week 1
STARTED
|
9
|
15
|
7
|
7
|
7
|
11
|
|
Study Week 1
COMPLETED
|
7
|
14
|
7
|
5
|
7
|
11
|
|
Study Week 1
NOT COMPLETED
|
2
|
1
|
0
|
2
|
0
|
0
|
|
Study Week 2
STARTED
|
7
|
14
|
7
|
5
|
7
|
11
|
|
Study Week 2
COMPLETED
|
7
|
14
|
7
|
5
|
7
|
11
|
|
Study Week 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Study Week 3
STARTED
|
7
|
14
|
7
|
5
|
7
|
11
|
|
Study Week 3
COMPLETED
|
7
|
14
|
7
|
4
|
7
|
11
|
|
Study Week 3
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
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%.
|
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%.
|
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%.
|
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%.
|
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%.
|
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%.
|
|---|---|---|---|---|---|---|
|
Study Week 1
Withdrawal by Subject
|
2
|
1
|
0
|
2
|
0
|
0
|
|
Study Week 3
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Effect of Energy Density Over 5 Days in Preschool Children
Baseline characteristics by cohort
| Measure |
All Study Participants
n=49 Participants
Enrolled participants who completed the trial and whose data was not excluded from analysis
|
|---|---|
|
Age, Continuous
|
4.3 years
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1-5 in Weeks 1, 2, and 3Population: Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods.
Differences in daily intake of food and beverages by energy, in kcal
Outcome measures
| Measure |
100% Food Energy Density
n=49 Participants
Baseline Food Energy Density
Food Energy Density: Food Energy density manipulated
|
80% Food Energy Density
n=49 Participants
Lower Food Energy Density
Food Energy Density: Food Energy density manipulated
|
120% Food Energy Density
n=49 Participants
Higher Food Energy Density
Food Energy Density: Food Energy density manipulated
|
|---|---|---|---|
|
Differences in Food and Beverage Intake by Energy
|
956 kilocalories
Standard Error 37
|
884 kilocalories
Standard Error 38
|
1041 kilocalories
Standard Error 38
|
PRIMARY outcome
Timeframe: Days 1-5 in weeks 1, 2, and 3Population: Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods.
Differences in daily intake of food and beverages by weight, in grams
Outcome measures
| Measure |
100% Food Energy Density
n=49 Participants
Baseline Food Energy Density
Food Energy Density: Food Energy density manipulated
|
80% Food Energy Density
n=49 Participants
Lower Food Energy Density
Food Energy Density: Food Energy density manipulated
|
120% Food Energy Density
n=49 Participants
Higher Food Energy Density
Food Energy Density: Food Energy density manipulated
|
|---|---|---|---|
|
Differences in Food and Beverage Intake by Weight
|
997 grams
Standard Error 41
|
952 grams
Standard Error 41
|
988 grams
Standard Error 41
|
SECONDARY outcome
Timeframe: Days 1-5 in weeks 1, 2, and 3Population: Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods.
Differences in daily intake of food and beverages by energy density, in kcal/g
Outcome measures
| Measure |
100% Food Energy Density
n=49 Participants
Baseline Food Energy Density
Food Energy Density: Food Energy density manipulated
|
80% Food Energy Density
n=49 Participants
Lower Food Energy Density
Food Energy Density: Food Energy density manipulated
|
120% Food Energy Density
n=49 Participants
Higher Food Energy Density
Food Energy Density: Food Energy density manipulated
|
|---|---|---|---|
|
Differences in Food and Beverage Intake by Energy Density
|
0.97 kilocalories/gram
Standard Error 0.02
|
0.93 kilocalories/gram
Standard Error 0.02
|
1.06 kilocalories/gram
Standard Error 0.03
|
Adverse Events
80% Food Energy Density
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
100% Food Energy Density
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
120% Food Energy Density
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