NCT01414699

Brief Summary

The purpose of this study is to determine the extent to which manipulation of dietary variety and course sequence affects fruit intake and overall energy intake in preschool-aged children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

August 10, 2011

Last Update Submit

April 3, 2018

Conditions

Keywords

dietary varietycourse sequencepreschoolchild feeding

Outcome Measures

Primary Outcomes (1)

  • Total grams of snack consumed.

    Total grams of snack consumed by participants over the 4-week study (with 1 snack per week) period will be determined by subtracting pre- and post-consumption weight of the snack provided.

    4 weeks

Study Arms (4)

One-Course, Variety

ACTIVE COMPARATOR

Participants will receive a snack in one course with a variety of fruit.

Behavioral: Variety

Two-Course, Variety

ACTIVE COMPARATOR

Participants will receive a snack in two courses with a variety of fruit.

Behavioral: Variety

One-course, Non-Variety

ACTIVE COMPARATOR

Participants will receive a snack in one course with no variety of fruit.

Behavioral: Non-Variety

Two-Course, Non-Variety

ACTIVE COMPARATOR

Participants will receive a snack in two courses with no variety of fruit.

Behavioral: Non-Variety

Interventions

VarietyBEHAVIORAL

These conditions will have snack served with an increase of fruit variety.

One-Course, VarietyTwo-Course, Variety
Non-VarietyBEHAVIORAL

These conditions will receive a snack without a variety of fruit.

One-course, Non-VarietyTwo-Course, Non-Variety

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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 applesauce, peaches and cheese cubes, and be able to consume foods with a spoon.

You may not qualify if:

  • Children allergic to applesauce, peaches, 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

Knoxville, Tennessee, 37916, United States

Location

Related Links

Study Officials

  • Hollie A Raynor, PhD

    University of Tennessee, Knoxville

    PRINCIPAL INVESTIGATOR
  • Chelsi C Cardoso, BS

    University of Tennessee, Knoxville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 11, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2015

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations