NCT02017158

Brief Summary

The purpose of this study is to develop, disseminate, and evaluate a web-based nutrition and gardening game using interactive, multiplatform and mobile gaming, rich narrative, a pedagogical agent, meaningful play, and experiential learning to prevent/treat obesity in minority 3-5th grade youth and their families.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

5.3 years

First QC Date

December 9, 2013

Last Update Submit

March 29, 2017

Conditions

Obesity

Keywords

ObesityNutritionChildren

Outcome Measures

Primary Outcomes (1)

  • Dietary intake

    Change in scores on dietary intake as measured by the Block dietary screener, administered one week pre-intervention and one week post intervention. Length of intervention is approximately six weeks, depending upon how schools schedule the 12 game modules

    pre-intervention and post-intervention (approximately 8 weeks apart)

Secondary Outcomes (2)

  • Preference for fruits and vegetables

    Pre-intervention and post-intervention (approximately 8 weeks apart)

  • Gardening knowledge

    Pre and post intervention (approximately 8 weeks apart)

Study Arms (2)

Virtual Sprouts

EXPERIMENTAL

The Virtual Sprouts intervention arm will play Virtual Sprouts in a school-based implementation of the game.

Other: Virtual Sprouts

Control group

NO INTERVENTION

The control group will consist of students who will not play the Virtual Sprouts game at school.

Interventions

Virtual SproutsOTHER

The Virtual Sprouts intervention group will play Virtual Sprouts in a school-based implementation of the game.

Virtual Sprouts

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child in 3rd, 4th, or 5th grade

You may not qualify if:

  • Child in grades earlier than 3rd or later than 5th

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Los Angeles Charter Schools

Los Angeles, California, 90004, United States

Location

University of Southern California

Los Angeles, California, 90032, United States

Location

Related Publications (3)

  • Twiss J, Dickinson J, Duma S, Kleinman T, Paulsen H, Rilveria L. Community gardens: lessons learned from California Healthy Cities and Communities. Am J Public Health. 2003 Sep;93(9):1435-8. doi: 10.2105/ajph.93.9.1435.

    PMID: 12948958BACKGROUND

  • Kipke MD, Iverson E, Moore D, Booker C, Ruelas V, Peters AL, Kaufman F. Food and park environments: neighborhood-level risks for childhood obesity in east Los Angeles. J Adolesc Health. 2007 Apr;40(4):325-33. doi: 10.1016/j.jadohealth.2006.10.021. Epub 2007 Feb 5.

    PMID: 17367725BACKGROUND

  • Robinson EJ, Mitchell P. Children's interpretation of messages from a speaker with a false belief. Child Dev. 1992 Jun;63(3):639-52.

    PMID: 1600828BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Donna Spruijt-Metz, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

  • Chad Lane, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

  • Giselle Ragusa, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

  • Marientina Gotsis, MFA

    University of Southern California

    STUDY DIRECTOR

  • Jaimie Davis, PhD, RD

    University of Texas at Austin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, USC/CESR Mobile and Connected Health Program

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 20, 2013

Study Start

September 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 31, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)