Imbalance of Constituents of Food IntakeNCT01412697
An Intervention Targeting Fruit and Vegetable Intake Among Rural Youth
A study testing Fruit and vegetable intake in rural youth in people with Imbalance of Constituents of Food Intake, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Imbalance of Constituents of Food Intake
- What is being tested?
- Fruit and vegetable intake in rural youth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,119 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Nov 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 7 grade youth
- attending participating middle schools
Who cannot join
- In grades other than 7th grade
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Imbalance of Constituents of Food Intake
- Being tested
- Fruit and vegetable intake in rural youth
- Keywords
- Rural youth, Theory-based intervention, Randomized by schools, Fruit and vegetable intake, Health classes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit and vegetable intake in rural youthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Fruit and Vegetable Intake Behavioral Intervention | Experimental | measure fruit and vegetable intake in rural youth based on specific behavioral intervention. Receives: Behavioral: Fruit and vegetable intake in rural youth |
| Control Group | No intervention | control group received the standard health information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fruit and vegetable intake
We surveyed students on fruit/vegetable intake at baseline, immediate post intervention and 1 year follow-up
Measured: Up to one year
Secondary outcomes (1)
Confidence to increase fruit and vegetable intake
We surveyed students on their confidence in increasing their daily servings of fruit and vegetalbes.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startSep 2008
- Primary completionJun 2009
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Imbalance of Constituents of Food IntakeStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Danish, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412697
- Sponsor's protocol ID
- #8520369
- Status last verified
- Sep 2025
- First submitted
- 3 Aug 2011
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wilson DB, Jones RM, McClish D, Westerberg AL, Danish S. Fruit and vegetable intake among rural youth following a school-based randomized controlled trial. Prev Med. 2012 Feb;54(2):150-6. doi: 10.1016/j.ypmed.2011.11.005. Epub 2011 Dec 3.
PubMed 22178819
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruit and Vegetable Intake Among Rural Youth Following a School-based Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01412697
- Acronym / sponsor ID
- #8520369
- Conditions
- Imbalance of Constituents of Food Intake
- Keywords
- Rural youth, Theory-based intervention, Randomized by schools, Fruit and vegetable intake, Health classes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,119 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Aug 2011 (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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fruit and Vegetable Intake Behavioral Intervention | Experimental | Behavioral: Fruit and vegetable intake in rural youthmeasure fruit and vegetable intake in rural youth based on specific behavioral intervention. |
| Control Group | No intervention | –control group received the standard health information |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 7 grade youth
- attending participating middle schools
Key exclusion criteria (1 listed)
- In grades other than 7th grade
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 |
|---|---|---|
| Fruit and vegetable intake in rural youthA 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. | Behavioural | Fruit and Vegetable Intake Behavioral Intervention |
Primary outcome
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
1 secondary outcome
Confidence to increase fruit and vegetable intake
Time frame: Up to one year
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 16 Sep 2025.
- Derived from this study: PubMed 22178819Wilson DB, Jones RM, McClish D, Westerberg AL, Danish S. Fruit and vegetable intake among rural youth following a school-based randomized controlled trial. Prev Med. 2012 Feb;54(2):150-6. doi: 10.1016/j.ypmed.2011.11.005. Epub 2011 Dec 3.
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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.
Steven Danish, PhD principal investigator
Virginia Commonwealth 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 Fruit and vegetable intake in rural youth in people with Imbalance of Constituents of Food Intake, run by Virginia Commonwealth 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 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 16 Sep 2025. 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?
Fruit and vegetable intake (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01412697, which also lists 1 linked publication.
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 16 Sep 2025.