Trial Outcomes & Findings for Effect of Portion Size Over 5 Days in Preschool Children (NCT NCT02963987)

Last Updated: 2019-06-11

Results Overview

Differences between 100% and 150% portion size conditions in energy intake (kcal) determined from weighed intakes of food and beverages

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Days 1-5 in Periods 1 and 2

Results posted on

2019-06-11

Participant Flow

Participants for the study were recruited from 7 classrooms of 2 childcare centers in University Park, PA from June 2015 to April 2016.

Participant milestones

Participant milestones
Measure	100% Portion Size First, Then 150% Portion Size 100% Food and Beverage Portion Size in first period, then 150% Food and Beverage Portion Size in second period	150% Portion Size First, Then 100% Portion Size 150% Food and Beverage Portion Size in first period, then 100% Food and Beverage Portion Size in second period
First Intervention Period STARTED	31	19
First Intervention Period COMPLETED	31	19
First Intervention Period NOT COMPLETED	0	0
Second Intervention Period STARTED	31	19
Second Intervention Period COMPLETED	31	19
Second Intervention Period NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Portion Size Over 5 Days in Preschool Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=46 Participants All participants in the crossover trial of two interventions in two periods
Age, Continuous	4.3 years STANDARD_DEVIATION 0.6 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 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	0 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants

PRIMARY outcome

Timeframe: Days 1-5 in Periods 1 and 2

Population: Data of 4 enrolled participants was excluded from analysis for absence from meals on 3 or more days in one intervention period.

Differences between 100% and 150% portion size conditions in energy intake (kcal) determined from weighed intakes of food and beverages

Outcome measures

Outcome measures
Measure	100% Portion Size n=46 Participants 100% Food and Beverage Portion Size (baseline portions)	150% Portion Size n=46 Participants 150% Food and Beverage Portion Size (increased 50% from baseline portions)
Differences in Food and Beverage Intake by Energy	914 kilocalories Standard Error 44	1081 kilocalories Standard Error 44

SECONDARY outcome

Timeframe: Days 1-5 in Periods 1 and 2

Population: Data of 4 enrolled participants was excluded from analysis for absence from meals on 3 or more days in one intervention period

Differences between 100% and 150% portion size conditions in daily energy density (kcal/g) determined from weighed intakes of food and beverages

Outcome measures

Outcome measures
Measure	100% Portion Size n=46 Participants 100% Food and Beverage Portion Size (baseline portions)	150% Portion Size n=46 Participants 150% Food and Beverage Portion Size (increased 50% from baseline portions)
Differences in Food and Beverage Intake by Energy Density	1.45 kilocalories/gram Standard Error 0.04	1.50 kilocalories/gram Standard Error 0.04

SECONDARY outcome

Timeframe: Days 1-5 in Periods 1 and 2

Population: Data of 4 enrolled participants was excluded from analysis for absence from meals on 3 or more days in one intervention period

Differences between 100% and 150% portion size conditions in daily weighed intake of food and beverages (g)

Outcome measures

Outcome measures
Measure	100% Portion Size n=46 Participants 100% Food and Beverage Portion Size (baseline portions)	150% Portion Size n=46 Participants 150% Food and Beverage Portion Size (increased 50% from baseline portions)
Differences in Food and Beverage Intake by Weight	899 grams Standard Error 45	1042 grams Standard Error 46

Adverse Events

100% Portion Size

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

150% 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