- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01412697
An Intervention Targeting Fruit and Vegetable Intake Among Rural Youth
September 15, 2025 updated by: Virginia Commonwealth University
Fruit and Vegetable Intake Among Rural Youth Following a School-based Randomized Controlled Trial
The investigators implemented a theory-based randomized controlled trial in ten rural Virginia middle schools in 2008-2010 and assessed the impact on health behaviors including fruit/vegetable intake as a primary outcome.
Schools were randomized to intervention or control groups.
Goal setting, peer leaders, and in-class workshops were intervention features.
Seventh graders filled out surveys on health behaviors, psycho-social variables, and demographic characteristics.
The investigators expected schools receiving the intervention to report a higher fruit-vegetable intake compared to control schools where students received standard health information.
Sample (n=1,119) was 48.5% female, 50% White, with a mean age of 12.6 years.
Fruit/vegetable intake was significantly higher in intervention schools at immediate post and at 1-year follow-up compared to controls.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1119
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Crewe, Virginia, United States, 23930
- Nottoway Middle School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 7 grade youth
- attending participating middle schools
Exclusion Criteria:
- In grades other than 7th grade
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fruit and Vegetable Intake Behavioral Intervention
measure fruit and vegetable intake in rural youth based on specific behavioral intervention.
|
A theory based health behavior intervention, developed for youth is presented to seventh grade youth over 8 weeks to test their improvement in their intake of fruits and vegetables.
|
|
No Intervention: Control Group
control group received the standard health information
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fruit and vegetable intake
Time Frame: Up to one year
|
We surveyed students on fruit/vegetable intake at baseline, immediate post intervention and 1 year follow-up
|
Up to one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Confidence to increase fruit and vegetable intake
Time Frame: Up to one year
|
We surveyed students on their confidence in increasing their daily servings of fruit and vegetalbes.
|
Up to one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steven Danish, PhD, Virginia Commonwealth University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
August 3, 2011
First Submitted That Met QC Criteria
August 8, 2011
First Posted (Estimated)
August 9, 2011
Study Record Updates
Last Update Posted (Estimated)
September 16, 2025
Last Update Submitted That Met QC Criteria
September 15, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #8520369
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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