Effects of Energy Density on Self-served Snacks in Preschool Children
Self-served Snack Study for Preschool Children
1 other identifier
interventional
55
1 country
1
Brief Summary
The purpose of the study is to determine whether the energy density of snack foods affects the amounts that preschool children serve themselves and then consume. We will serve snacks that vary in energy density to preschool children in their childcare centers and measure the amount they serve themselves and consume. The results will have implications for guidance about the provision of snacks for preschool children and may help in identifying strategies for the prevention of obesity in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2021
CompletedFirst Posted
Study publicly available on registry
July 22, 2021
CompletedStudy Start
First participant enrolled
September 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2022
CompletedMarch 21, 2022
March 1, 2022
5 months
July 20, 2021
March 18, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Difference between interventions in the weight of self-served snack food
Weight served of snack food in grams
Study weeks 1 and 2
Difference between interventions in the weight of snack food consumed
Weight consumed of snack food in grams
Study weeks 1 and 2
Secondary Outcomes (4)
Difference between interventions in the volume of self-served snack food
Study weeks 1 and 2
Difference between interventions in the volume of snack food consumed
Study weeks 1 and 2
Difference between interventions in the energy of self-served snack food
Study weeks 1 and 2
Difference between interventions in the energy of snack food consumed
Study weeks 1 and 2
Study Arms (2)
Lower-energy-dense Snack
EXPERIMENTALTest snack with lower-energy-dense snack food
Higher-energy-dense Snack
EXPERIMENTALTest snack with higher-energy-dense snack food
Interventions
Snack meal with snack food having energy density less than 1.5 kcal/g
Snack meal with snack food having energy density greater than 1.5 kcal/g
Eligibility Criteria
You may qualify if:
- Children who are enrolled in a scheduled classroom of the participating childcare centers
- Children who are between the ages of 4 and 6 years old at the time of enrollment
You may not qualify if:
- Children who have tested positive or are showing symptoms of COVID-19, or have recently had potential exposure with a person with COVID-19
- Children who are allergic to any of the foods served
- Children whose diets exclude any of the foods served
- Children who are absent from the childcare center on the acclimation day or both study days
- Children who are not able to serve themselves the two foods that are provided during the acclimation day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Pennsylvania State University
University Park, Pennsylvania, 16802, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior
Study Record Dates
First Submitted
July 20, 2021
First Posted
July 22, 2021
Study Start
September 15, 2021
Primary Completion
February 24, 2022
Study Completion
March 3, 2022
Last Updated
March 21, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share