Trial Outcomes & Findings for Effect of Varying Proportions of Low and High Energy Dense Foods Over 5 Days in Preschool Children (NCT NCT03242863)

NCT ID: NCT03242863

Last Updated: 2020-11-18

Results Overview

Differences in daily energy consumed of food and beverages, in kilocalories

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 57 participants
• Primary outcome timeframe: Day 1-5 in weeks 1, 2, and 3
• Results posted on: 2020-11-18

Participant Flow

Children were recruited from three childcare centers in central Pennsylvania between November 2017 and March 2019

Participant milestones

Measure	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.	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.	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.	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.	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.	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.
Study Week 1 STARTED	13	16	4	4	15	5
Study Week 1 COMPLETED	13	15	4	4	12	5
Study Week 1 NOT COMPLETED	0	1	0	0	3	0
Study Week 2 STARTED	13	15	4	4	12	5
Study Week 2 COMPLETED	13	15	4	4	12	5
Study Week 2 NOT COMPLETED	0	0	0	0	0	0
Study Week 3 STARTED	13	15	4	4	12	5
Study Week 3 COMPLETED	13	15	4	4	12	5
Study Week 3 NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Measure	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.	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.	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.	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.	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.	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.
Study Week 1 Withdrawal by Subject	0	1	0	0	3	0

Baseline Characteristics

Effect of Varying Proportions of Low and High Energy Dense Foods Over 5 Days in Preschool Children

Baseline characteristics by cohort

Measure	Entire Study Population n=53 Participants Enrolled participants who completed the study
Age, Continuous	4.4 years STANDARD_DEVIATION 0.8 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 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	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Region of Enrollment United States	53 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1-5 in weeks 1, 2, and 3

Differences in daily energy consumed of food and beverages, in kilocalories

Outcome measures

Measure	Control n=53 Participants Baseline proportions of high and low energy dense foods.	Addition n=53 Participants Increased portion of low energy dense foods.	Substitution n=53 Participants Increased portion of low energy dense foods substituted for equal portion of foods higher in energy density.
Differences in Food and Beverage Intake by Energy	1059 kilocalories per day Standard Error 33	1118 kilocalories per day Standard Error 35	977 kilocalories per day Standard Error 34

PRIMARY outcome

Timeframe: Day 1-5 in weeks 1, 2, and 3

Differences in daily weight consumed of food and beverages, in grams

Outcome measures

Measure	Control n=53 Participants Baseline proportions of high and low energy dense foods.	Addition n=53 Participants Increased portion of low energy dense foods.	Substitution n=53 Participants Increased portion of low energy dense foods substituted for equal portion of foods higher in energy density.
Differences in Food and Beverage Intake by Weight	868 grams per day Standard Error 35	955 grams per day Standard Error 36	908 grams per day Standard Error 35

PRIMARY outcome

Timeframe: Day 1-5 in weeks 1, 2, and 3

Differences in daily weight consumed of vegetables and fruit, in grams

Outcome measures

Measure	Control n=53 Participants Baseline proportions of high and low energy dense foods.	Addition n=53 Participants Increased portion of low energy dense foods.	Substitution n=53 Participants Increased portion of low energy dense foods substituted for equal portion of foods higher in energy density.
Differences in Food and Beverage Intake by Weight	225 grams per day Standard Error 15	296 grams per day Standard Error 15	315 grams per day Standard Error 15

SECONDARY outcome

Timeframe: Day 1-5 in weeks 1, 2, and 3

Differences in daily energy density consumed of food and beverages, in kilocalories/gram

Outcome measures

Measure	Control n=53 Participants Baseline proportions of high and low energy dense foods.	Addition n=53 Participants Increased portion of low energy dense foods.	Substitution n=53 Participants Increased portion of low energy dense foods substituted for equal portion of foods higher in energy density.
Differences in Food and Beverage Intake by Energy Density	1.29 kilocalories/gram per day Standard Error 0.038	1.21 kilocalories/gram per day Standard Error 0.039	1.14 kilocalories/gram per day Standard Error 0.038

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Addition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Substitution

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: bjr4@psu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place