WAVE~Ripples for Change: Obesity Prevention in Active Youth

March 23, 2022 updated by: Oregon State University

The WAVE~Ripples for Change: Obesity Prevention in Active Youth in Afterschool Programs Using Virtual- and Real-World Experiential Learning

Intervention targets youth ages 14 - 19 participating in soccer teams. The intervention group will be given face to face nutrition lessons and have access to an online immersive learning environment. The comparison group will not. The project will test if the immersive learning environment is effective in preventing unhealthy weight gain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
498

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group

All intervention youth participants will receive three components:

  1. Nutrition lessons
  2. Virtual World learning environment
  3. Newsletters
Behavioral: Nutrition lessons
Face-to-face interactive group lessons delivered in the classroom.
Behavioral: Virtual world learning environment
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:
  • Rippleville
Other: Newsletter
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
Other: Newsletter
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Siew Sun Wong, PhD, OSU
  • Principal Investigator: Melinda M Manore, PhD, RD, OSU

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will provide IPD (with participant's full name deidentified with a unique ID) upon request after the completion of the study for research and education purpose (not for-profit/commercial use). Types of data available include demography, anthropometry, nutrition, physical activity, sleep, psychosocial, and knowledge in sports nutrition.

IPD Sharing Time Frame

The data will become available in 2019 for up to two years.

IPD Sharing Access Criteria

All requests will be sent to the Lead PD (Wong) and approval will be made jointly by both PD Wong & Manore.

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.

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