NCT01412697

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,119

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

August 3, 2011

Last Update Submit

September 15, 2025

Conditions

Keywords

Rural youthTheory-based interventionRandomized by schoolsFruit and vegetable intakeHealth classes

Outcome Measures

Primary Outcomes (1)

  • Fruit and vegetable intake

    We surveyed students on fruit/vegetable intake at baseline, immediate post intervention and 1 year follow-up

    Up to one year

Secondary Outcomes (1)

  • Confidence to increase fruit and vegetable intake

    Up to one year

Study Arms (2)

Fruit and Vegetable Intake Behavioral Intervention

EXPERIMENTAL

measure fruit and vegetable intake in rural youth based on specific behavioral intervention.

Behavioral: Fruit and vegetable intake in rural youth

Control Group

NO INTERVENTION

control group received the standard health information

Interventions

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.

Fruit and Vegetable Intake Behavioral Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • grade youth
  • attending participating middle schools

You may not qualify if:

  • In grades other than 7th grade

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottoway Middle School

Crewe, Virginia, 23930, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Fruit

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Steven Danish, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2011

First Posted

August 9, 2011

Study Start

September 1, 2008

Primary Completion

June 1, 2009

Study Completion

November 1, 2010

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations