Caloric IntakeNCT01414699
The Influence of Dietary Variety and Course Sequence on Fruit Intake in Preschool-Aged Children
A study testing Variety and Non-Variety in people with Caloric Intake, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Caloric Intake
- What is being tested?
- Variety and Non-Variety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Eating and Activity Laboratory
Knoxville, Tennessee, 37916
About this study
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.
Read the 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.
- Conditions
- Caloric Intake
- Being tested
- Variety, Non-Variety
- Keywords
- dietary variety, course sequence, preschool, child feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VarietyBehavioural
These conditions will have snack served with an increase of fruit variety.
Non-VarietyBehavioural
These conditions will receive a snack without a variety of fruit.
| Study group | Role | What they receive |
|---|---|---|
| One-Course, Variety | Active comparator | Participants will receive a snack in one course with a variety of fruit. Receives: Behavioral: Variety |
| Two-Course, Variety | Active comparator | Participants will receive a snack in two courses with a variety of fruit. Receives: Behavioral: Variety |
| One-course, Non-Variety | Active comparator | Participants will receive a snack in one course with no variety of fruit. Receives: Behavioral: Non-Variety |
| Two-Course, Non-Variety | Active comparator | Participants will receive a snack in two courses with no variety of fruit. Receives: Behavioral: Non-Variety |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caloric IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Hollie A Raynor, PhD, Principal investigator, University of Tennessee, KnoxvilleChelsi C Cardoso, BS, Principal investigator, University of Tennessee, Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414699
- Sponsor's protocol ID
- 8585B
- Status last verified
- Apr 2018
- First submitted
- 10 Aug 2011
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Dietary Variety and Course Sequence on Fruit Intake in Preschool-Aged Children
- ClinicalTrials.gov ID
- NCT01414699
- Acronym / sponsor ID
- 8585B
- Conditions
- Caloric Intake
- Keywords
- dietary variety, course sequence, preschool, child feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| One-Course, Variety | Active comparator | Behavioral: VarietyParticipants will receive a snack in one course with a variety of fruit. |
| Two-Course, Variety | Active comparator | Behavioral: VarietyParticipants will receive a snack in two courses with a variety of fruit. |
| One-course, Non-Variety | Active comparator | Behavioral: Non-VarietyParticipants will receive a snack in one course with no variety of fruit. |
| Two-Course, Non-Variety | Active comparator | Behavioral: Non-VarietyParticipants will receive a snack in two courses with no variety of fruit. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VarietyThese conditions will have snack served with an increase of fruit variety. | Behavioural | One-Course, Variety, Two-Course, Variety |
| Non-VarietyThese conditions will receive a snack without a variety of fruit. | Behavioural | One-course, Non-Variety, Two-Course, Non-Variety |
Primary outcome
Total grams of snack consumed.
Time frame: 4 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- This is the website for the Healthy Eating and Activity Laboratory (HEAL), where this study is being conducted.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hollie A Raynor, PhD principal investigator
University of Tennessee, Knoxville
Chelsi C Cardoso, BS principal investigator
University of Tennessee, Knoxville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variety and Non-Variety in people with Caloric Intake, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total grams of snack consumed. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.