ObesityNCT02746939
Student Outcomes in Fitness and Nutrition ISEO
A study testing InSciEd Out Fitness and Nutrition Curriculum in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
The study is designed to examine whether curriculum, designed in partnership with teachers at Moreland Elementary school in West St. Paul and Mayo Clinic InSciEd Out scientists, is able to influence the behavior and health literacy of students. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- InSciEd Out Fitness and Nutrition Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2016to 31 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students attending 3rd and 4th grade classes at Lincoln K-8 Choice Elementary School in Rochester, MN or Moreland Elementary School in West St. Paul, MN who assent to the study
Who cannot join
- Students attending 3rd and 4th grade classes at Lincoln K-8 Choice Elementary School in Rochester, MN or Moreland Elementary School in West St. Paul, MN whose parents chose to opt-out of the study or who do not assent to the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Student Behavior Outcomes in Fitness and Nutrition Integrated Science Education Outreach (InSciEd Out, ISEO)
The study is designed to examine whether curriculum, designed in partnership with teachers at Moreland Elementary school in West St. Paul and Mayo Clinic InSciEd Out scientists, is able to influence the behavior and health literacy of students. This information will be collected in surveys before and after the students are given the curriculum during the school day.
Read the detailed description
The research will implement a short battery of two survey inventories to measure student outcomes under InSciEd Out Fitness and Nutrition curriculum that is currently administered in 3rd and 4th grade at Lincoln K-8 Choice School. One is a grade-level adapted version of the National Youth Physical Activity and Nutrition Survey (NYPANS) authored by the United States Center for Disease Control (CDC). The other is a grade-level adapted version of the Newest Vital Sign (NVS) health literacy assessment authored by Pfizer and adapted by Dr. Linda Aldoory at the University of Maryland.
These assessments will help inform the health promotion activities of the InSciEd Out partnership within Lincoln K-8 Choice in Rochester, Minnesota (MN) and Moreland Elementary in West St. Paul, MN who originally wrote the curriculum. These assessments will be key to curricular revision and expansion to other schools that partner with InSciEd Out. As such, this study is a single cohort, internally controlled pre-post assessment of an existing behavioral intervention. Pending pilot study success, future follow-up studies are projected to be parallel-group, nonrandomized clinical trials of a treatment school versus a control school with grade levels expansion. This study will inform activities within the InSciEd Out network inside Rochester Public Schools (RPS), where grades Kindergarten through 2nd and 5th through 8th curricula is currently being built. Previously RPS-approved Mayo Clinic Institutional Review Board (IRB) #13-003263 describes the format of InSciEd Out programming in detail, but the general framework of this study operates upon an established partnership between InSciEd Out researchers and Lincoln K-8 Choice/Moreland Elementary administrators, teachers, students, and parents.
IRB#13-003263 describes the format of InSciEd Out programming in detail, but the general framework of this study operates upon an established partnership between InSciEd Out researchers and administration, teachers, and students at Lincoln K-8 Choice Elementary.
- Conditions
- Obesity
- Being tested
- InSciEd Out Fitness and Nutrition Curriculum
- Keywords
- program evaluation, health literacy, fitness, nutrition, education
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InSciEd Out Fitness and Nutrition CurriculumBehavioural
Science curriculum is designed in partnership with 3rd and 4th grade teachers and InSciEd Out scientists. The curriculum is designed to focus on inquiry driven science, and also aims to decrease high risk behaviors that can lead to obesity in the students.
| Study group | Role | What they receive |
|---|---|---|
| Pre-curriculum assessment | No intervention | Assessments will be administered to 3rd and 4th grade students prior to receiving curriculum training in fitness and nutrition. |
| Post-curriculum assessment | Experimental | Assessments will be administered to 3rd and 4th grade students (matched from pre-curriculum assessment) after receiving 4-6 week InSciEd Out Fitness and Nutrition Curriculum. Receives: Behavioral: InSciEd Out Fitness and Nutrition Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with completion of ISEO Fitness and Nutrition Curriculum
students will undergo 4-6 weeks of ISEO fitness and nutrition curriculum as part of their 3rd or 4th grade coursework. Classroom teachers will decide when to administer the curriculum, but should be completed by January 2017 in our target classrooms.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start29 Mar 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Why it stopped: Staffing change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Pierret, Mayo Clinic
- Investigators
- Christopher K Pierret, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746939
- Sponsor's protocol ID
- 16-001162
- Status last verified
- Jan 2019
- First submitted
- 8 Apr 2016
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Student Behavior Outcomes in Fitness and Nutrition Integrated Science Education Outreach (InSciEd Out, ISEO)
- ClinicalTrials.gov ID
- NCT02746939
- Acronym / sponsor ID
- 16-001162
- Conditions
- Obesity
- Keywords
- program evaluation, health literacy, fitness, nutrition, education
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Staffing change
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Mar 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 21 Apr 2016 (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 study is designed to examine whether curriculum, designed in partnership with teachers at Moreland Elementary school in West St. Paul and Mayo Clinic InSciEd Out scientists, is able to influence the behavior and health literacy of students. This information will be collected in surveys before and after the students are given the curriculum during the school day.
Detailed description
The research will implement a short battery of two survey inventories to measure student outcomes under InSciEd Out Fitness and Nutrition curriculum that is currently administered in 3rd and 4th grade at Lincoln K-8 Choice School. One is a grade-level adapted version of the National Youth Physical Activity and Nutrition Survey (NYPANS) authored by the United States Center for Disease Control (CDC). The other is a grade-level adapted version of the Newest Vital Sign (NVS) health literacy assessment authored by Pfizer and adapted by Dr. Linda Aldoory at the University of Maryland.
These assessments will help inform the health promotion activities of the InSciEd Out partnership within Lincoln K-8 Choice in Rochester, Minnesota (MN) and Moreland Elementary in West St. Paul, MN who originally wrote the curriculum. These assessments will be key to curricular revision and expansion to other schools that partner with InSciEd Out. As such, this study is a single cohort, internally controlled pre-post assessment of an existing behavioral intervention. Pending pilot study success, future follow-up studies are projected to be parallel-group, nonrandomized clinical trials of a treatment school versus a control school with grade levels expansion. This study will inform activities within the InSciEd Out network inside Rochester Public Schools (RPS), where grades Kindergarten through 2nd and 5th through 8th curricula is currently being built. Previously RPS-approved Mayo Clinic Institutional Review Board (IRB) #13-003263 describes the format of InSciEd Out programming in detail, but the general framework of this study operates upon an established partnership between InSciEd Out researchers and Lincoln K-8 Choice/Moreland Elementary administrators, teachers, students, and parents.
IRB#13-003263 describes the format of InSciEd Out programming in detail, but the general framework of this study operates upon an established partnership between InSciEd Out researchers and administration, teachers, and students at Lincoln K-8 Choice Elementary.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-curriculum assessment | No intervention | –Assessments will be administered to 3rd and 4th grade students prior to receiving curriculum training in fitness and nutrition. |
| Post-curriculum assessment | Experimental | Behavioral: InSciEd Out Fitness and Nutrition CurriculumAssessments will be administered to 3rd and 4th grade students (matched from pre-curriculum assessment) after receiving 4-6 week InSciEd Out Fitness and Nutrition Curriculum. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students attending 3rd and 4th grade classes at Lincoln K-8 Choice Elementary School in Rochester, MN or Moreland Elementary School in West St. Paul, MN who assent to the study
Key exclusion criteria (1 listed)
- Students attending 3rd and 4th grade classes at Lincoln K-8 Choice Elementary School in Rochester, MN or Moreland Elementary School in West St. Paul, MN whose parents chose to opt-out of the study or who do not assent to the study
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 |
|---|---|---|
| InSciEd Out Fitness and Nutrition CurriculumScience curriculum is designed in partnership with 3rd and 4th grade teachers and InSciEd Out scientists. The curriculum is designed to focus on inquiry driven science, and also aims to decrease high risk behaviors that can lead to obesity in the students. | Behavioural | Post-curriculum assessment |
Primary outcome
Number of participants with completion of ISEO Fitness and Nutrition Curriculum
Time frame: 9 months
students will undergo 4-6 weeks of ISEO fitness and nutrition curriculum as part of their 3rd or 4th grade coursework. Classroom teachers will decide when to administer the curriculum, but should be completed by January 2017 in our target classrooms.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- 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.
Christopher K Pierret principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InSciEd Out Fitness and Nutrition Curriculum in people with Obesity, run by Mayo Clinic 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 1 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: withdrawn, as of the sponsor's last update on 4 Jan 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of participants with completion of ISEO Fitness and Nutrition Curriculum (time frame: 9 months). 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 4 Jan 2019.