Feeding Behavior
Conditions
Brief summary
In this study, the investigators will vary the proportions of high- and low-energy-dense foods served to preschool children at all meals and snacks during three 5-day periods. In the three experimental conditions, the same foods will be served; only the amounts and proportions of foods will be varied. In the Baseline condition, typical proportions of age-appropriate foods will be served. In the Addition condition, the portion sizes of low-energy-dense foods will be increased, and in the Substitution condition, the portions of low-energy-dense foods will be increased by replacing an equivalent amount of foods higher in energy density. The primary aim is to determine the effect on children's energy intake of varying the proportion of low- and high-energy-dense foods served, either by addition or substitution, over 5 days. It is hypothesized that children will consume less energy when they are served meals in which low-energy-dense foods are substituted for foods higher in energy density over 5 days and that children will consume more energy when served meals to which low-energy-dense foods are added. Additionally, we will test the hypothesis that daily energy intake in the three conditions will begin to converge across the 5-day period.
Interventions
OTHERFood proportionality
Proportions of high and low energy dense foods manipulated
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 daycare 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 | Day 1-5 in weeks 1, 2, and 3 | Differences in daily energy consumed of food and beverages, in kilocalories |
| Differences in Food and Beverage Intake by Weight | Day 1-5 in weeks 1, 2, and 3 | Differences in daily weight consumed of food and beverages, in grams |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Food and Beverage Intake by Energy Density | Day 1-5 in weeks 1, 2, and 3 | Differences in daily energy density consumed of food and beverages, in kilocalories/gram |
Countries
United States
Participant flow
Recruitment details
Children were recruited from three childcare centers in central Pennsylvania between November 2017 and March 2019
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Enrolled participants who completed the study | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Study Week 1 | Withdrawal by Subject | 0 | 1 | 0 | 0 | 3 | 0 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 4.4 years STANDARD_DEVIATION 0.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 53 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 57 | 0 / 57 |
| other Total, other adverse events | 0 / 57 | 0 / 57 | 0 / 57 |
| serious Total, serious adverse events | 0 / 57 | 0 / 57 | 0 / 57 |
Outcome results
Primary
Differences in Food and Beverage Intake by Energy
Differences in daily energy consumed of food and beverages, in kilocalories
Time frame: Day 1-5 in weeks 1, 2, and 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Differences in Food and Beverage Intake by Energy | 1059 kilocalories per day | Standard Error 33 |
| Addition | Differences in Food and Beverage Intake by Energy | 1118 kilocalories per day | Standard Error 35 |
| Substitution | Differences in Food and Beverage Intake by Energy | 977 kilocalories per day | Standard Error 34 |
p-value: <0.0001Mixed Models Analysis
Primary
Differences in Food and Beverage Intake by Weight
Differences in daily weight consumed of food and beverages, in grams
Time frame: Day 1-5 in weeks 1, 2, and 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Differences in Food and Beverage Intake by Weight | 868 grams per day | Standard Error 35 |
| Addition | Differences in Food and Beverage Intake by Weight | 955 grams per day | Standard Error 36 |
| Substitution | Differences in Food and Beverage Intake by Weight | 908 grams per day | Standard Error 35 |
p-value: 0.0015Mixed Models Analysis
Primary
Differences in Food and Beverage Intake by Weight
Differences in daily weight consumed of vegetables and fruit, in grams
Time frame: Day 1-5 in weeks 1, 2, and 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Differences in Food and Beverage Intake by Weight | 225 grams per day | Standard Error 15 |
| Addition | Differences in Food and Beverage Intake by Weight | 296 grams per day | Standard Error 15 |
| Substitution | Differences in Food and Beverage Intake by Weight | 315 grams per day | Standard Error 15 |
p-value: <0.0001Mixed Models Analysis
Secondary
Differences in Food and Beverage Intake by Energy Density
Differences in daily energy density consumed of food and beverages, in kilocalories/gram
Time frame: Day 1-5 in weeks 1, 2, and 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Differences in Food and Beverage Intake by Energy Density | 1.29 kilocalories/gram per day | Standard Error 0.038 |
| Addition | Differences in Food and Beverage Intake by Energy Density | 1.21 kilocalories/gram per day | Standard Error 0.039 |
| Substitution | Differences in Food and Beverage Intake by Energy Density | 1.14 kilocalories/gram per day | Standard Error 0.038 |
p-value: <0.0001Mixed Models Analysis