Pediatric ObesityNCT02522559
Using Herbs and Spices to Increase Children's Acceptance and Intake of Vegetables in School Lunches
A study testing Spice Intervention in people with Pediatric Obesity, run by Penn State University at 1 site in United States.
Trial summary
Herbs and spices offer one potential solution to the recent decline in children taking school lunch because they can increase the palatability of foods without adding salt and fat. However, there is currently limited evidence on how to successfully integrate herbs and spices into the school lunch menu. Read more about this study
- Who is it for?
- Ages 11 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Spice Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2015to 22 Dec 2017
- 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 11 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Student in Bald Eagle Area Middle/High School
- Parents of students in Bald Eagle Area Middle/High School
- School Food Service Employees at the Bald Eagle Area Middle/High School
Who cannot join
- Students/children who have food allergies to herb/spice blend ingredients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bald Eagle Middle/High School
Wingate, Pennsylvania, 16823
About this study
Herbs and spices offer one potential solution to the recent decline in children taking school lunch because they can increase the palatability of foods without adding salt and fat. However, there is currently limited evidence on how to successfully integrate herbs and spices into the school lunch menu. Developing evidence-based methods to teach school cafeteria workers to prepare healthy and tasty vegetable dishes with the addition of herbs and spices is a research priority. The investigators hypothesize that herbs and spices can be used to increase acceptance, intake, and participation in the school lunch program among 6th - 12th grade students from Central Pennsylvania.
Read the detailed description
What this study will add to the literature: Herbs and spices offer one potential solution to the recent decline in children taking school lunch because they can increase the palatability of foods without adding salt and fat. However, there is currently limited evidence on how to successfully integrate herbs and spices into the school lunch menu. Developing evidence-based methods to teach school cafeteria workers to prepare healthy and tasty vegetable dishes with the addition of herbs and spices is a research priority. This research will provide evidence that herbs and spices can be used to increase acceptance, intake, and participation in the school lunch program among 6th - 12th grade students from Central Pennsylvania.
- Conditions
- Pediatric Obesity
- Being tested
- Spice Intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spice InterventionOther
Spice Intervention:Novel herb and spice blends will be used in cafeteria recipes.
| Study group | Role | What they receive |
|---|---|---|
| Spice Intervention | Experimental | Spice intervention: Student-approved vegetable recipes will be served in the school cafeteria. Receives: Other: Spice Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surveys defining barriers to vegetable consumption at Bald Eagle Area Middle/High School
Conduct surveys of students, parents and food service experts to gather information describing ways to increase vegetable intake at Bald Eagle Area Middle/High School
Measured: Baseline
Taste tests to quantify the change in liking of vegetable recipes
Student's liking of vegetables prepared with herbs/spices will be assessed during the taste tests by setting up sensory panels in their culinary and consumer education classes. Participating students will rate liking and will provide written feedback to inform recipe development.
Measured: Baseline and after recipe development (approximately 10 months). Prior to intervention.
Change in vegetable plate waste
Weight of vegetable disappearance from the school cafeteria, minus waste weight, in kg.
Measured: Baseline, Intervention and Follow-up (1 and 6 months)
Secondary outcomes (2)
School lunch program participation
Percentage of children who are participating in the school lunch program will be assessed the school years prior to and immediately after the intervention
Measured: Baseline, Intervention and Followup (1 and 6 months)
Post-meal comment cards
Student's will rate satisfaction with the school lunches by completing anonymous, post-meal comment cards during the baseline, intervention, and follow-up phases.
Measured: Baseline, Intervention and Followup (1 and 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start14 Apr 2015
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- McCormick Science Institute
- Responsible party
- Principal investigator, Kathleen Loralee Keller, Penn State University
- Investigators
- Kathleen L. Keller, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522559
- Sponsor's protocol ID
- Spiceinschool01
- Other IDs
- Spices
- Status last verified
- Jan 2018
- First submitted
- 6 Apr 2015
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Herbs and Spices to Increase Children's Acceptance and Intake of Vegetables in School Lunches
- ClinicalTrials.gov ID
- NCT02522559
- Acronym / sponsor ID
- Spiceinschool01
- Conditions
- Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- McCormick Science Institute
- Study start
- 14 Apr 2015 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 13 Aug 2015 (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.
Herbs and spices offer one potential solution to the recent decline in children taking school lunch because they can increase the palatability of foods without adding salt and fat. However, there is currently limited evidence on how to successfully integrate herbs and spices into the school lunch menu. Developing evidence-based methods to teach school cafeteria workers to prepare healthy and tasty vegetable dishes with the addition of herbs and spices is a research priority. The investigators hypothesize that herbs and spices can be used to increase acceptance, intake, and participation in the school lunch program among 6th - 12th grade students from Central Pennsylvania.
Detailed description
What this study will add to the literature: Herbs and spices offer one potential solution to the recent decline in children taking school lunch because they can increase the palatability of foods without adding salt and fat. However, there is currently limited evidence on how to successfully integrate herbs and spices into the school lunch menu. Developing evidence-based methods to teach school cafeteria workers to prepare healthy and tasty vegetable dishes with the addition of herbs and spices is a research priority. This research will provide evidence that herbs and spices can be used to increase acceptance, intake, and participation in the school lunch program among 6th - 12th grade students from Central Pennsylvania.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spice Intervention | Experimental | Other: Spice InterventionSpice intervention: Student-approved vegetable recipes will be served in the school cafeteria. |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Student in Bald Eagle Area Middle/High School
- Parents of students in Bald Eagle Area Middle/High School
- School Food Service Employees at the Bald Eagle Area Middle/High School
Key exclusion criteria (1 listed)
- Students/children who have food allergies to herb/spice blend ingredients.
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 |
|---|---|---|
| Spice InterventionSpice Intervention:Novel herb and spice blends will be used in cafeteria recipes. | Other | Spice Intervention |
Primary outcome
Surveys defining barriers to vegetable consumption at Bald Eagle Area Middle/High School
Time frame: Baseline
Conduct surveys of students, parents and food service experts to gather information describing ways to increase vegetable intake at Bald Eagle Area Middle/High School
Taste tests to quantify the change in liking of vegetable recipes
Time frame: Baseline and after recipe development (approximately 10 months). Prior to intervention.
Student's liking of vegetables prepared with herbs/spices will be assessed during the taste tests by setting up sensory panels in their culinary and consumer education classes. Participating students will rate liking and will provide written feedback to inform recipe development.
Change in vegetable plate waste
Time frame: Baseline, Intervention and Follow-up (1 and 6 months)
Weight of vegetable disappearance from the school cafeteria, minus waste weight, in kg.
2 secondary outcomes
School lunch program participation
Time frame: Baseline, Intervention and Followup (1 and 6 months)
Post-meal comment cards
Time frame: Baseline, Intervention and Followup (1 and 6 months)
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 Jan 2018.
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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, PhD principal investigator
Penn 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 Spice 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 3 inclusion and 1 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 Jan 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?
Surveys defining barriers to vegetable consumption at Bald Eagle Area Middle/High School (time frame: Baseline). 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 Jan 2018.