NCT00936507

Brief Summary

The purpose of this randomized controlled study using a crossover design is to investigate the main effect of portion size and food type (low-energy dense vs. high-energy dense) on caloric intake.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

3 months

First QC Date

July 8, 2009

Last Update Submit

April 3, 2018

Conditions

Caloric Intake

Keywords

energy densityportion sizechild feeding

Study Arms (4)

Low-ED, small portion

EXPERIMENTAL
Other: Energy Density/Portion Size

Low-ED, large portion

EXPERIMENTAL
Other: Energy Density/Portion Size

High-ED, small portion

EXPERIMENTAL
Other: Energy Density/Portion Size

High-ED, large portion

EXPERIMENTAL
Other: Energy Density/Portion Size

Interventions

Energy Density/Portion SizeOTHER
High-ED, large portionHigh-ED, small portionLow-ED, large portionLow-ED, small portion

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All children that are ≥3 years of age enrolled in the ELC preschool with parental consent can participate.
  • Eligible children must also like both the applesauce and the pudding, and be able to consume foods with a spoon.

You may not qualify if:

  • Children allergic to applesauce or chocolate pudding or who are lactose- intolerant will not be included in the study.
  • Did not attend all feeding sessions.
  • Did not consume more than 5 grams from any of the foods on an occasion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Eating and Activity Laboratory, University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Interventions

Portion Size

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 8, 2009

First Posted

July 10, 2009

Study Start

September 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

US(1)