ObesityPhase 2NCT03179852
Effects of Nutrition Education on 3rd and 5th Grade Student's Fruit and Vegetable Consumption and Knowledge
A Phase 2 study testing nutrition education in people with Obesity, run by Central Washington University.
Trial summary
The primary objective is to assess pre- and post-intervention nutrition education knowledge and preference. The secondary objective is to assess pre- and post-intervention fruit and vegetable consumption via a plate waste study. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- nutrition education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jun 2017
- Phase
- Phase 2
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participated in the National School Lunch Program
Who cannot join
- Did not participate in the National School Lunch Program
About this study
The primary objective is to assess pre- and post-intervention nutrition education knowledge and preference. The secondary objective is to assess pre- and post-intervention fruit and vegetable consumption via a plate waste study.
Read the detailed description
Background: The prevalence of overweight and obese children in the United States is at epidemic proportions, making it a recognized public health priority. Overweight and obese children are more likely to remain overweight and obese as adults, which increases their risk for developing obesity-related diseases and psychological disorders. Research shows that regular consumption of fruit and vegetables (F/V) may reduce the risk of obesity and obesity-related diseases yet most American school children fail to meet recommended intakes .
Objective: The purpose of this study was to determine if a F/V-targeted nutrition education intervention would increase F/V preference, knowledge, and consumption among elementary-school students.
Methods: Eight 20-minute nutrition lessons, focusing on F/V consumption, were administered over an eight-week period to 3rd and 5th grade students (N=150) at a local Ellensburg School District elementary school . Pre/post surveys were used to examine F/V knowledge and preference. Researchers observed and photographed students' lunches for 5-consecutive days pre- and post- intervention to assess possible change in consumption patterns.
Results: Data is currently under analysis. Conclusions: To be determined June 2017.
- Conditions
- Obesity
- Being tested
- 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.
nutrition educationBehavioural
nutrition education
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nutrition knowledge
surveys
Measured: Nutrition knowledge surveys will be administered during week 1 and again at week 10 after the 8 week nutrition education intervention
Change in fruit and vegetable preferences
surveys
Measured: Fruit and vegetable preference surveys will be administered during week 1 and again at week 10 after the 8 week nutrition education intervention
Secondary outcomes (1)
Change in fruit and vegetable intake
plate waste study
Measured: Plate waste will be measured via the quarter waste method during week 1 and again at week 10 after the 8 week nutrition education intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study startJan 2017
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
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.
- 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 2
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179852
- Sponsor's protocol ID
- 16124
- Status last verified
- Jun 2017
- First submitted
- 30 May 2017
- Last updated
- 7 Jun 2017
- 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 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutrition Education on 3rd and 5th Grade Student's Fruit and Vegetable Consumption and Knowledge
- ClinicalTrials.gov ID
- NCT03179852
- Acronym / sponsor ID
- 16124
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Central Washington UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 7 Jun 2017 (actual)
- 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 primary objective is to assess pre- and post-intervention nutrition education knowledge and preference. The secondary objective is to assess pre- and post-intervention fruit and vegetable consumption via a plate waste study.
Detailed description
Background: The prevalence of overweight and obese children in the United States is at epidemic proportions, making it a recognized public health priority. Overweight and obese children are more likely to remain overweight and obese as adults, which increases their risk for developing obesity-related diseases and psychological disorders. Research shows that regular consumption of fruit and vegetables (F/V) may reduce the risk of obesity and obesity-related diseases yet most American school children fail to meet recommended intakes .
Objective: The purpose of this study was to determine if a F/V-targeted nutrition education intervention would increase F/V preference, knowledge, and consumption among elementary-school students.
Methods: Eight 20-minute nutrition lessons, focusing on F/V consumption, were administered over an eight-week period to 3rd and 5th grade students (N=150) at a local Ellensburg School District elementary school . Pre/post surveys were used to examine F/V knowledge and preference. Researchers observed and photographed students' lunches for 5-consecutive days pre- and post- intervention to assess possible change in consumption patterns.
Results: Data is currently under analysis. Conclusions: To be determined June 2017.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participated in the National School Lunch Program
Key exclusion criteria (1 listed)
- Did not participate in the National School Lunch Program
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 |
|---|---|---|
| nutrition educationnutrition education | Behavioural | – |
Primary outcome
Change in nutrition knowledge
Time frame: Nutrition knowledge surveys will be administered during week 1 and again at week 10 after the 8 week nutrition education intervention
surveys
Change in fruit and vegetable preferences
Time frame: Fruit and vegetable preference surveys will be administered during week 1 and again at week 10 after the 8 week nutrition education intervention
surveys
1 secondary outcome
Change in fruit and vegetable intake
Time frame: Plate waste will be measured via the quarter waste method during week 1 and again at week 10 after the 8 week nutrition education intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nutrition education in people with Obesity, run by Central Washington University.
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: status not confirmed, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change in nutrition knowledge (time frame: Nutrition knowledge surveys will be administered during week 1 and again at week 10 after the 8 week nutrition education intervention). The study lists 2 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 7 Jun 2017.