Pediatric ObesityCTSNCT03043118
Children's Taste Study to Increase Vegetable Intake in Preschoolers
A study testing Variety Intervention in people with Pediatric Obesity, run by Penn State University at 1 site in United States.
Trial summary
Studies have shown that when exposed to a variety of food and flavor options people tend to consume more than when only one item is presented. This strategy has been used to increase vegetable intake in adults and during snacktime in children. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Variety Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 2 Nov 2016
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Acceptance of test meal foods
- Generally healthy
Who cannot join
- Food allergies
- Medications (prescription or OTC) that can affect taste, smell or appetite
- Medical conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: A Pilot Study to Test the Influence of Vegetable Flavor Variety Using Herbs and Spices on Preschool Children's Vegetable Intake
Studies have shown that when exposed to a variety of food and flavor options people tend to consume more than when only one item is presented. This strategy has been used to increase vegetable intake in adults and during snacktime in children. Increasing vegetable consumption in children is important because higher vegetable intake has been associated with reduced risk of disease and because vegetables can help prevent weight gain by lowering the energy density of a meal. The purpose of this study was to investigate the effects of using herb and spice blends to create flavor variety in carrots as a model vegetable in a laboratory test meal. We predict that children will consume more vegetables and that the energy density of the meal will be lower when a variety of seasoned carrots are presented in comparison to a single flavor. A secondary goal of the study was to determine other influences that may predict children's liking and intake of seasoned vegetables, such as previous exposure, infant feeding practices, and genetic bitter sensitivity.
- Conditions
- Pediatric Obesity
- Being tested
- Variety Intervention
- Keywords
- Eating Behaviors, Preschool, Vegetable Intake
- Medical subject headings
- Pediatric Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variety InterventionOther
Vegetable flavor variety created with multiple herb and spice blends
| Study group | Role | What they receive |
|---|---|---|
| Variety | Experimental | Children receive three servings of vegetables each prepared with a different herb and spice blend. Receives: Other: Variety Intervention |
| No Variety - Control | No intervention | Children receive three servings of vegetables each prepared with the same herb and spice blend. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chang in Vegetable Intake
Consumption is measured by pre- and post- weights of carrot offered in both the variety and no variety conditions
Measured: Baseline and 1 week
Change in Total Food Intake
Consumption is measured by pre- and post- weights of all meal items offered in both the variety and no variety conditions
Measured: Baseline and 1 week
Change in Meal Energy Density
Calculated from the total calories consumed divided by the grams of food eaten
Measured: Baseline and 1 week
Secondary outcomes (5)
Spice Intake Questionnaire
A survey of maternally reported herb and spice consumption during pregnancy and breastfeeding as well as current home use
Measured: Baseline
Home Spice Checklist
A comprehensive checklist of 34 herbs and spices for parents to fill out at home to evaluate children's overall herb and spice exposure
Measured: Baseline
Infant Feeding Practices
A survey of maternally reported feeding practices, include breastfeeding, formula feeding, and introduction to solid foods.
Measured: Baseline
Liking of Broccoli with Herbs and Spices
Liking is measured using a child friendly 5-pt hedonic scale; pilot data for future studies looking to apply this technique to green vegetables
Measured: Baseline
Liking of Carrots with Herb and Spice Blends
Liking is measured using a child friendly 5-pt hedonic scale
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study startFeb 2015
- Primary completion2 Nov 2016
- Study completion2 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Loralee Keller, Penn State University
- Investigators
- Kathleen L Keller, Ph.D., Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043118
- Sponsor's protocol ID
- ChildrensTasteStudy
- Acronym
- CTS
- Status last verified
- Apr 2022
- First submitted
- 6 Oct 2016
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Test the Influence of Vegetable Flavor Variety Using Herbs and Spices on Preschool Children's Vegetable Intake
- ClinicalTrials.gov ID
- NCT03043118
- Acronym / sponsor ID
- CTS / ChildrensTasteStudy
- Conditions
- Pediatric Obesity
- Keywords
- Eating Behaviors, Preschool, Vegetable Intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- 2 Nov 2016 (actual)
- Study completion
- 2 Nov 2016 (actual)
- First posted
- 3 Feb 2017 (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.
Studies have shown that when exposed to a variety of food and flavor options people tend to consume more than when only one item is presented. This strategy has been used to increase vegetable intake in adults and during snacktime in children. Increasing vegetable consumption in children is important because higher vegetable intake has been associated with reduced risk of disease and because vegetables can help prevent weight gain by lowering the energy density of a meal. The purpose of this study was to investigate the effects of using herb and spice blends to create flavor variety in carrots as a model vegetable in a laboratory test meal. We predict that children will consume more vegetables and that the energy density of the meal will be lower when a variety of seasoned carrots are presented in comparison to a single flavor. A secondary goal of the study was to determine other influences that may predict children's liking and intake of seasoned vegetables, such as previous exposure, infant feeding practices, and genetic bitter sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Variety | Experimental | Other: Variety InterventionChildren receive three servings of vegetables each prepared with a different herb and spice blend. |
| No Variety - Control | No intervention | –Children receive three servings of vegetables each prepared with the same herb and spice blend. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Acceptance of test meal foods
- Generally healthy
Key exclusion criteria (3 listed)
- Food allergies
- Medications (prescription or OTC) that can affect taste, smell or appetite
- Medical conditions
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 |
|---|---|---|
| Variety InterventionVegetable flavor variety created with multiple herb and spice blends | Other | Variety |
Primary outcome
Chang in Vegetable Intake
Time frame: Baseline and 1 week
Consumption is measured by pre- and post- weights of carrot offered in both the variety and no variety conditions
Change in Total Food Intake
Time frame: Baseline and 1 week
Consumption is measured by pre- and post- weights of all meal items offered in both the variety and no variety conditions
Change in Meal Energy Density
Time frame: Baseline and 1 week
Calculated from the total calories consumed divided by the grams of food eaten
5 secondary outcomes
Spice Intake Questionnaire
Time frame: Baseline
Home Spice Checklist
Time frame: Baseline
Infant Feeding Practices
Time frame: Baseline
Liking of Broccoli with Herbs and Spices
Time frame: Baseline
Liking of Carrots with Herb and Spice Blends
Time frame: Baseline
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 2022.
- Individual participant dataSharing planned: No
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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.
Kathleen L Keller, Ph.D. principal investigator
The Pennsylvania State University
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 Intervention in people with Pediatric Obesity, run by Penn State University 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 2022. 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?
Chang in Vegetable Intake (time frame: Baseline and 1 week). The study lists 3 primary outcomes in all. 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 2022.