Childhood Obesity PreventionNCT03215485
WAVE~Ripples for Change: Obesity Prevention in Active Youth
A study testing Nutrition lessons, Virtual world learning environment and Newsletter in people with Childhood Obesity Prevention, run by Oregon State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Childhood Obesity Prevention
- What is being tested?
- Nutrition lessons, Virtual world learning environment and Newsletter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- non-English speakers (youth)
- prisoners
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Obesity Prevention
- Being tested
- Nutrition lessons, Virtual world learning environment, Newsletter
- Keywords
- adolescent, sports, nutrition, physical activity, body mass index, virtual world
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition lessonsBehavioural
Face-to-face interactive group lessons delivered in the classroom.
Virtual world learning environmentBehavioural
Also called Rippleville
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.
NewsletterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | All intervention youth participants will receive three components:
1. Nutrition lessons
2. Virtual World learning environment
3. Newsletters Receives: Behavioral: Nutrition lessons; Behavioral: Virtual world learning environment; Other: Newsletter |
| Comparison | Active comparator | All comparison youth participants will only receive one component:
1) Newsletters Receives: Other: Newsletter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 .
Measured: Change from baseline at 12 and 24 months later
Secondary outcomes (1)
Growth-adjusted Body Mass Index (kg/m2)
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).
Measured: Change from baseline at 12 and 24 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study startAug 2014
- Primary completionSep 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Obesity PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There is one intervention group and one comparison group.
- Masking
- None (open label)
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siew Sun Wong, PhD, Principal investigator, OSUMelinda M Manore, PhD, RD, Principal investigator, OSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215485
- Sponsor's protocol ID
- 6317
- Status last verified
- Mar 2022
- First submitted
- 19 May 2016
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The WAVE~Ripples for Change: Obesity Prevention in Active Youth in Afterschool Programs Using Virtual- and Real-World Experiential Learning
- ClinicalTrials.gov ID
- NCT03215485
- Acronym / sponsor ID
- 6317
- Conditions
- Childhood Obesity Prevention
- Keywords
- adolescent, sports, nutrition, physical activity, body mass index, virtual world
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There is one intervention group and one comparison group.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Nutrition lessons, Behavioral: Virtual world learning environment, Other: NewsletterAll intervention youth participants will receive three components: 1. Nutrition lessons 2. Virtual World learning environment 3. Newsletters |
| Comparison | Active comparator | Other: NewsletterAll comparison youth participants will only receive one component: 1) Newsletters |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- non-English speakers (youth)
- prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition lessonsFace-to-face interactive group lessons delivered in the classroom. | Behavioural | Intervention Group |
| Virtual world learning environmentAlso: RipplevilleEvery 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. | Behavioural | Intervention Group |
| NewsletterAll 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. | Other | Comparison, Intervention Group |
Primary outcome
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.
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.
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 .
1 secondary outcome
Growth-adjusted Body Mass Index (kg/m2)
Time frame: Change from baseline at 12 and 24 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siew Sun Wong, PhD principal investigator
OSU
Melinda M Manore, PhD, RD principal investigator
OSU
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition lessons, Virtual world learning environment and Newsletter in people with Childhood Obesity Prevention, run by Oregon State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.