NCT03215485

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
498

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

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

August 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2016

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

4.1 years

First QC Date

May 19, 2016

Last Update Submit

March 23, 2022

Conditions

Keywords

adolescentsportsnutritionphysical activitybody mass indexvirtual world

Outcome Measures

Primary Outcomes (3)

  • Nutrition: Meet specific good groups dietary recommendation/guideline for fruit, vegetables, fat, and sugar intakes.

    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.

    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.

    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 Outcomes (1)

  • Growth-adjusted Body Mass Index (kg/m2)

    Change from baseline at 12 and 24 months later

Study Arms (2)

Intervention Group

EXPERIMENTAL

All intervention youth participants will receive three components: 1. Nutrition lessons 2. Virtual World learning environment 3. Newsletters

Behavioral: Nutrition lessonsBehavioral: Virtual world learning environmentOther: Newsletter

Comparison

ACTIVE COMPARATOR

All comparison youth participants will only receive one component: 1\) Newsletters

Other: Newsletter

Interventions

Face-to-face interactive group lessons delivered in the classroom.

Intervention Group

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.

Also known as: Rippleville
Intervention Group

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.

ComparisonIntervention Group

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • non-English speakers (youth)
  • prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Siew Sun Wong, PhD

    OSU

    PRINCIPAL INVESTIGATOR
  • Melinda M Manore, PhD, RD

    OSU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: There is one intervention group and one comparison group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2016

First Posted

July 12, 2017

Study Start

August 1, 2014

Primary Completion

September 1, 2018

Study Completion

December 31, 2018

Last Updated

April 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
The data will become available in 2019 for up to two years.
Access Criteria
All requests will be sent to the Lead PD (Wong) and approval will be made jointly by both PD Wong \& Manore.