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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02963987
Other study ID # ChildFood501
Secondary ID R01DK0825802011-
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date April 2016

Study information

Verified date May 2019
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, the investigators varied the portion size of all meals served during two 5-day periods. During one period, baseline amounts of all foods and beverages were served, and during the other, the portion size of all items was increased by 50%. The primary aim of the study is to determine the effect of varying the portion size of foods and beverages served over 5 days on energy intake in preschool children.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group 3 Years to 5 Years
Eligibility Inclusion Criteria:

- Attending one of the designated childcare centers

Exclusion Criteria:

- Food Allergies

- Food Restrictions

- Health Issues that Preclude Participation

- Not available for duration of the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Food and Beverage Portion Size
Variations of Food and Beverage Portion Size (100% Baseline portions and increased 50% for 150% portions)

Locations

Country Name City State
United States Laboratory for the Study of Human Ingestive Behavior University Park Pennsylvania
United States The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior University Park Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Penn State University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Smethers AD, Roe LS, Sanchez CE, Zuraikat FM, Keller KL, Kling SMR, Rolls BJ. Portion size has sustained effects over 5 days in preschool children: a randomized trial. Am J Clin Nutr. 2019 May 1;109(5):1361-1372. doi: 10.1093/ajcn/nqy383. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Differences in Food and Beverage Intake by Energy Differences between 100% and 150% portion size conditions in energy intake (kcal) determined from weighed intakes of food and beverages Days 1-5 in Periods 1 and 2
Secondary Differences in Food and Beverage Intake by Energy Density Differences between 100% and 150% portion size conditions in daily energy density (kcal/g) determined from weighed intakes of food and beverages Days 1-5 in Periods 1 and 2
Secondary Differences in Food and Beverage Intake by Weight Differences between 100% and 150% portion size conditions in daily weighed intake of food and beverages (g) Days 1-5 in Periods 1 and 2
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