Effects of Energy Density and Portion Size of Milk in Preschool Children
3 other identifiers
interventional
143
1 country
1
Brief Summary
In this study, the investigators varied both the energy density and portion size of milk served with a meal commonly consumed by preschool children. The milk used in this study is commercially available and reflects typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of milk energy density and portion size on preschool children's intake of the milk and the simultaneously served meal. The effect of milk energy density and portion size on children's total energy intake at the meal will also be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2014
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 22, 2016
CompletedFirst Posted
Study publicly available on registry
April 29, 2016
CompletedMarch 21, 2017
March 1, 2017
8 months
April 22, 2016
March 17, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Difference between experimental conditions for milk, food, and total intake by weight
Difference between experimental conditions in milk intake (weight in grams), food intake (weight in grams), total meal intake (weight in grams)
once a week for 4 weeks
Difference between experiential conditions for milk, food, and total intake by energy
Difference between experimental conditions for milk intake (energy in kcal), food intake (energy in kcal), and total meal energy intake (energy in kcal)
once a week for 4 weeks
Secondary Outcomes (1)
Meal energy density
once a week for 4 weeks
Study Arms (4)
Low energy density, small portion
EXPERIMENTALLow milk energy density and small portion size
Low energy density, large portion
EXPERIMENTALLow milk energy density and large portion size
High energy density, small portion
EXPERIMENTALHigh milk energy density and small portion size
High energy density, large portion
EXPERIMENTALHigh milk energy density and large portion size
Interventions
Low energy density milk served
High energy density milk served
Small portion of milk served
Large portion of milk served
Eligibility Criteria
You may qualify if:
- Children must be enrolled in participating childcare centers
You may not qualify if:
- Allergy or intolerance to any of the foods or beverages served
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior
University Park, Pennsylvania, 16802, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara J Rolls
The Pennsylvania State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Nutritional Sciences
Study Record Dates
First Submitted
April 22, 2016
First Posted
April 29, 2016
Study Start
September 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
March 21, 2017
Record last verified: 2017-03