The Influence of Dietary Variety and Course Sequence on Fruit Intake in Preschool-Aged Children

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

University of Tennessee

ClinicalTrials.gov Identifier:

NCT01414699

First received: August 10, 2011

Last updated: November 14, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 10, 2011

Last Updated Date

November 14, 2012

Start Date ^ICMJE

August 2011

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Total grams of snack consumed. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01414699 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Influence of Dietary Variety and Course Sequence on Fruit Intake in Preschool-Aged Children

Official Title ^ICMJE

The Influence of Dietary Variety and Course Sequence on Fruit Intake in Preschool-Aged Children

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.

Detailed Description

In the past two decades overweight and obesity rates in children (ages 2-19) have risen from 5% to 17%, with toddlers (ages 2-5) at 10%. Among children and adolescents the consumption of low-energy-dense foods, such as fruit and vegetables (F&Vs), remain below current recommendations. Therefore, strategies to increase low-energy-dense F&V intake and decrease high-energy-dense food intake aimed at young children are essential. Antecedents, or cues, can trigger eating. Therefore, manipulating food presentation can be utilized to produce certain behaviors. Dietary variety and course sequence are two examples of this relationship. It has been well established that high dietary variety leads to greater consumption patterns compared to low DV diets in adults. High DV has only been tested with problematic foods, and not with the goal of increasing F&V intake. Additionally, serving a first course meal can act as a preload to decrease intake of the second course entrée. Dietary variety and course sequence manipulations have been experimentally tested with caloric intake goals but never with the goal of increasing F&V intake. Therefore, 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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Caloric Intake

Intervention ^ICMJE

Behavioral: Variety
These conditions will have snack served with an increase of fruit variety.
Behavioral: Non-Variety
These conditions will receive a snack without a variety of fruit.

Study Arm (s)

Active Comparator: One-Course, Variety
Participants will receive a snack in one course with a variety of fruit.

Intervention: Behavioral: Variety
Active Comparator: Two-Course, Variety
Participants will receive a snack in two courses with a variety of fruit.

Intervention: Behavioral: Variety
Active Comparator: One-course, Non-Variety
Participants will receive a snack in one course with no variety of fruit.

Intervention: Behavioral: Non-Variety
Active Comparator: Two-Course, Non-Variety
Participants will receive a snack in two courses with no variety of fruit.

Intervention: Behavioral: Non-Variety

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

December 2013

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Gender

Both

Ages

3 Years to 6 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01414699

Other Study ID Numbers ^ICMJE

8585B

Has Data Monitoring Committee

Responsible Party

University of Tennessee

Study Sponsor ^ICMJE

University of Tennessee

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Hollie A Raynor, PhD	University of Tennessee, Knoxville
Principal Investigator:	Chelsi C Cardoso, BS	University of Tennessee, Knoxville

Information Provided By

University of Tennessee

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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