Feeding Behavior
Conditions
Brief summary
In this study, the investigators will vary the energy density of foods served during three 5-day periods. There will be a baseline condition, and then a condition where the energy density of food is lower and a condition where the energy density of food is higher. The primary aim is to determine the effect of varying the energy density of foods served over 5 days on energy intake in preschool children. It is hypothesized that mean daily energy intake will be greater when children are served higher energy dense foods over 5 days than when served lower energy dense foods over the same period. Additionally, it is hypothesized that daily energy intake in the conditions with higher and lower energy densities will begin to converge across the 5-day period.
Interventions
OTHERFood Energy Density
Food Energy density 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 | Days 1-5 in Weeks 1, 2, and 3 | Differences in daily intake of food and beverages by energy, in kcal |
| Differences in Food and Beverage Intake by Weight | Days 1-5 in weeks 1, 2, and 3 | Differences in daily intake of food and beverages by weight, in grams |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Food and Beverage Intake by Energy Density | Days 1-5 in weeks 1, 2, and 3 | Differences in daily intake of food and beverages by energy density, in kcal/g |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Enrolled participants who completed the trial and whose data was not excluded from analysis | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| 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
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 4.3 years STANDARD_DEVIATION 0.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Region of Enrollment United States | 49 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 56 | 0 / 56 |
| other Total, other adverse events | 0 / 56 | 0 / 56 | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 | 0 / 56 |
Outcome results
Primary
Differences in Food and Beverage Intake by Energy
Differences in daily intake of food and beverages by energy, in kcal
Time frame: Days 1-5 in Weeks 1, 2, and 3
Population: Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 100% Food Energy Density | Differences in Food and Beverage Intake by Energy | 956 kilocalories | Standard Error 37 |
| 80% Food Energy Density | Differences in Food and Beverage Intake by Energy | 884 kilocalories | Standard Error 38 |
| 120% Food Energy Density | Differences in Food and Beverage Intake by Energy | 1041 kilocalories | Standard Error 38 |
p-value: <0.0001Mixed Models Analysis
Primary
Differences in Food and Beverage Intake by Weight
Differences in daily intake of food and beverages by weight, in grams
Time frame: Days 1-5 in weeks 1, 2, and 3
Population: Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 100% Food Energy Density | Differences in Food and Beverage Intake by Weight | 997 grams | Standard Error 41 |
| 80% Food Energy Density | Differences in Food and Beverage Intake by Weight | 952 grams | Standard Error 41 |
| 120% Food Energy Density | Differences in Food and Beverage Intake by Weight | 988 grams | Standard Error 41 |
p-value: 0.1Mixed Models Analysis
p-value: 0.15Mixed Models Analysis
Secondary
Differences in Food and Beverage Intake by Energy Density
Differences in daily intake of food and beverages by energy density, in kcal/g
Time frame: Days 1-5 in weeks 1, 2, and 3
Population: Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 100% Food Energy Density | Differences in Food and Beverage Intake by Energy Density | 0.97 kilocalories/gram | Standard Error 0.02 |
| 80% Food Energy Density | Differences in Food and Beverage Intake by Energy Density | 0.93 kilocalories/gram | Standard Error 0.02 |
| 120% Food Energy Density | Differences in Food and Beverage Intake by Energy Density | 1.06 kilocalories/gram | Standard Error 0.03 |
p-value: <0.0001Mixed Models Analysis