Feeding Behavior
Conditions
Brief summary
In this study, the investigators varied the portion size of all meals served during two 5-day periods. During one period, baseline amounts of all foods and beverages were served, and during the other, the portion size of all items was increased by 50%. The primary aim of the study is to determine the effect of varying the portion size of foods and beverages served over 5 days on energy intake in preschool children.
Interventions
OTHERFood and Beverage Portion Size
Variations of Food and Beverage Portion Size (100% Baseline portions and increased 50% for 150% portions)
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
United States Department of Agriculture (USDA)
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* Attending one of the designated childcare centers
Exclusion criteria
* Food Allergies * Food Restrictions * Health Issues that Preclude Participation * Not available for duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Food and Beverage Intake by Energy | Days 1-5 in Periods 1 and 2 | Differences between 100% and 150% portion size conditions in energy intake (kcal) determined from weighed intakes of food and beverages |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Food and Beverage Intake by Energy Density | Days 1-5 in Periods 1 and 2 | Differences between 100% and 150% portion size conditions in daily energy density (kcal/g) determined from weighed intakes of food and beverages |
| Differences in Food and Beverage Intake by Weight | Days 1-5 in Periods 1 and 2 | Differences between 100% and 150% portion size conditions in daily weighed intake of food and beverages (g) |
Countries
United States
Participant flow
Recruitment details
Participants for the study were recruited from 7 classrooms of 2 childcare centers in University Park, PA from June 2015 to April 2016.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants in the crossover trial of two interventions in two periods | 46 |
| Total | 46 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 4.3 years STANDARD_DEVIATION 0.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Differences in Food and Beverage Intake by Energy
Differences between 100% and 150% portion size conditions in energy intake (kcal) determined from weighed intakes of food and beverages
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 100% Portion Size | Differences in Food and Beverage Intake by Energy | 914 kilocalories | Standard Error 44 |
| 150% Portion Size | Differences in Food and Beverage Intake by Energy | 1081 kilocalories | Standard Error 44 |
p-value: <0.0001Mixed Models Analysis
Secondary
Differences in Food and Beverage Intake by Energy Density
Differences between 100% and 150% portion size conditions in daily energy density (kcal/g) determined from weighed intakes of food and beverages
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 100% Portion Size | Differences in Food and Beverage Intake by Energy Density | 1.45 kilocalories/gram | Standard Error 0.04 |
| 150% Portion Size | Differences in Food and Beverage Intake by Energy Density | 1.50 kilocalories/gram | Standard Error 0.04 |
p-value: 0.006Mixed Models Analysis
Secondary
Differences in Food and Beverage Intake by Weight
Differences between 100% and 150% portion size conditions in daily weighed intake of food and beverages (g)
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 100% Portion Size | Differences in Food and Beverage Intake by Weight | 899 grams | Standard Error 45 |
| 150% Portion Size | Differences in Food and Beverage Intake by Weight | 1042 grams | Standard Error 46 |
p-value: <0.0001Mixed Models Analysis