An interventional study of Food proportionality in Feeding Behavior, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 3 Years to 5 Years. Per ClinicalTrials.gov, last updated 2020-11-18.
Sponsored by Penn State University · Not applicable, Interventional, and Prevention
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.
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Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
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Exclusion Criteria:
Baseline proportions of high and low energy dense foods.
Other: Food proportionality
Increased portion of low energy dense foods.
Other: Food proportionality
Increased portion of low energy dense foods substituted for equal portion of foods higher in energy density.
Other: Food proportionality
Proportions of high and low energy dense foods manipulated
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
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
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
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
Children were recruited from three childcare centers in central Pennsylvania between November 2017 and March 2019
| Milestone | Con First, Then Add, Then Sub | Add First, Then Sub, Then Con | Sub First, Then Con, Then Add | Con First, Then Sub, Then Add | Add First, Then Con, Then Sub | Sub First, Then Add, Then Con |
|---|---|---|---|---|---|---|
| Started | 13 | 16 | 4 | 4 | 15 | 5 |
| Completed | 13 | 15 | 4 | 4 | 12 | 5 |
| Not completed | 0 | 1 | 0 | 0 | 3 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 3 | 0 |
| Milestone | Con First, Then Add, Then Sub | Add First, Then Sub, Then Con | Sub First, Then Con, Then Add | Con First, Then Sub, Then Add | Add First, Then Con, Then Sub | Sub First, Then Add, Then Con |
|---|---|---|---|---|---|---|
| Started | 13 | 15 | 4 | 4 | 12 | 5 |
| Completed | 13 | 15 | 4 | 4 | 12 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Con First, Then Add, Then Sub | Add First, Then Sub, Then Con | Sub First, Then Con, Then Add | Con First, Then Sub, Then Add | Add First, Then Con, Then Sub | Sub First, Then Add, Then Con |
|---|---|---|---|---|---|---|
| Started | 13 | 15 | 4 | 4 | 12 | 5 |
| Completed | 13 | 15 | 4 | 4 | 12 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Differences in daily energy consumed of food and beverages, in kilocalories
| kilocalories per day | Control | Addition | Substitution |
|---|---|---|---|
| Differences in Food and Beverage Intake by Energy | 1059 ± 33 | 1118 ± 35 | 977 ± 34 |
Differences in daily weight consumed of food and beverages, in grams
| grams per day | Control | Addition | Substitution |
|---|---|---|---|
| Differences in Food and Beverage Intake by Weight | 868 ± 35 | 955 ± 36 | 908 ± 35 |
Differences in daily weight consumed of vegetables and fruit, in grams
| grams per day | Control | Addition | Substitution |
|---|---|---|---|
| Differences in Food and Beverage Intake by Weight | 225 ± 15 | 296 ± 15 | 315 ± 15 |
Differences in daily energy density consumed of food and beverages, in kilocalories/gram
| kilocalories/gram per day | Control | Addition | Substitution |
|---|---|---|---|
| Differences in Food and Beverage Intake by Energy Density | 1.29 ± 0.038 | 1.21 ± 0.039 | 1.14 ± 0.038 |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/57 (0%) | 0/57 (0%) | 0/57 (0%) |
| Addition | 0/57 (0%) | 0/57 (0%) | 0/57 (0%) |
| Substitution | 0/57 (0%) | 0/57 (0%) | 0/57 (0%) |
| Age, Continuous(years) | Entire Study Population |
|---|---|
| Mean | 4.4 ± 0.8 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 25 |
| Male | 28 |
| Ethnicity (NIH/OMB)(Participants) | Entire Study Population |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 44 |
| Unknown or Not Reported | 6 |
| Race (NIH/OMB)(Participants) | Entire Study Population |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 7 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 31 |
| More than one race | 6 |
| Unknown or Not Reported | 7 |
| Region of Enrollment(participants) | Entire Study Population |
|---|---|
| United States | 53 |
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