- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03215485
WAVE~Ripples for Change: Obesity Prevention in Active Youth
The WAVE~Ripples for Change: Obesity Prevention in Active Youth in Afterschool Programs Using Virtual- and Real-World Experiential Learning
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Active youth are just as likely to develop poor dietary habits that can contribute to obesity later in life, after high school sports has ended. However, youth in sports may provide a key "window of opportunity" to teach them about eating health foods if that information is tied to sport performance. This project will test to see if that is true.
The virtual world is an idea medium for learning for this project. The project will test whether it indeed can result in behavior change more effectively than just more traditional face to face learning.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- youth ages 14 - 19 at baseline
- enrolled in a high school soccer program
- living with a parent/caregiver in Oregon
- without medical condition that hinders them from consuming normal healthy diets
- has assess to the internet during the 2-year study
- proficient in English
Exclusion Criteria:
- non-English speakers (youth)
- prisoners
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
All intervention youth participants will receive three components:
|
Face-to-face interactive group lessons delivered in the classroom.
Every participant has their own unique avatar in the virtual world learning environment named Rippleville.
They can choose to complete quests, watch archived nutrition video lessons, explore, and socialize with other avatars.
They receive rewards (Rippleville dollar and badges) for their efforts.
Other Names:
All participants in the intervention and comparison groups receive up to 10 professional newsletters on topics related to sports nutrition and performance, healthy eating and active living tips.
|
|
Active Comparator: Comparison
All comparison youth participants will only receive one component: 1) Newsletters |
All participants in the intervention and comparison groups receive up to 10 professional newsletters on topics related to sports nutrition and performance, healthy eating and active living tips.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutrition: Meet specific good groups dietary recommendation/guideline for fruit, vegetables, fat, and sugar intakes.
Time Frame: Change from baseline at 12 and 24 months later
|
Intakes of fat, sugar, fruits and vegetables are measured by self-reported screener using the Block Food Frequency Questionnaires (FFQ).
Change in intake frequencies are compared baseline, 12 and 24 months later.
|
Change from baseline at 12 and 24 months later
|
|
Physical activity: Meet moderate to vigorous physical activity (MVPA) recommendation.
Time Frame: Change from baseline at 12 and 24 months later
|
MVPA is measured by total steps and minutes per day with the use of a wearable lifestyle tracker such as the Fitbit.
Average steps during soccer season and outside soccer season are compared.
|
Change from baseline at 12 and 24 months later
|
|
Sleep about 8 hours/day.
Time Frame: Change from baseline at 12 and 24 months later
|
Together with MVPA, sleep is measured by average number of sleep hours per day as self-reported by participants via written and/or electronic surveys .
|
Change from baseline at 12 and 24 months later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Growth-adjusted Body Mass Index (kg/m2)
Time Frame: Change from baseline at 12 and 24 months later
|
Height and body weight are measured using a stadiometer (SECA 217, SECA Corp., Singapore) and a Tanita scale (TM-300A, Tanita Corp., Itabashi-Ku, Tokyo, Japan).
|
Change from baseline at 12 and 24 months later
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Siew Sun Wong, PhD, OSU
- Principal Investigator: Melinda M Manore, PhD, RD, OSU
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6317
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
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.
Clinical Trials on Childhood Obesity Prevention
-
Northwell HealthNational Heart, Lung, and Blood Institute (NHLBI)RecruitingPrevention Childhood Obesity | Feasibility and AcceptabilityUnited States
-
Tehran University of Medical SciencesUnknownChildhood Obesity PreventionIran, Islamic Republic of
-
Cornell UniversityCompletedChildhood Obesity Prevention
-
Universidad Autonoma de Nuevo LeonUniversidad de la SabanaCompletedPrevention Childhood ObesityMexico
-
The Miriam HospitalHassenfeld Child Health Innovation InstituteCompletedChildhood Obesity PreventionUnited States
-
Fundacion para la Formacion e Investigacion Sanitarias...UnknownChildhood Obesity PreventionSpain
-
Harokopio UniversityCompletedPrevention of Childhood ObesityGreece
-
Fundacion Miguel ServetUniversidad Pública de Navarra; NavarraBiomed Biomedical Research CenterEnrolling by invitationCommunity Health Education | Prevention of Childhood ObesitySpain
-
University of Texas at AustinNational Institutes of Health (NIH)RecruitingInfant Growth | Childhood Obesity Prevention | Parenting BehaviorUnited States
-
Universiti Sultan Zainal AbidinRecruitingChildhood Obesity PreventionMalaysia
Clinical Trials on Nutrition lessons
-
University of GuamUniversity of HawaiiCompleted
-
Temple UniversityThe School District of Philadelphia; The Food TrustCompleted
-
University of RochesterEastman Performing Arts Medicine Center; University of Rochester Aging Institute and other collaboratorsCompletedMild Cognitive Impairment (MCI) | Memory Decline | Memory Disorders, Age RelatedUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH); Annie E. Casey FoundationCompleted
-
University of Vic - Central University of CataloniaNot yet recruitingPhysical Activity | Executive FunctionSpain
-
Fundacion para la Investigacion Biomedica del Hospital...Withdrawn
-
Istituti Clinici Scientifici Maugeri SpARecruiting
-
Mazonson & Santas Inc.Completed
-
University of Southern CaliforniaCompleted
-
Istituto Scientifico Romagnolo per lo Studio e...Active, not recruitingQuality of Life | Fatigue | Radiotherapy; Complications | Physiological Stress | Female Breast CancerItaly