ObesityNCT02134275
Whole Body Vibration Training for Healthy Body Composition in Young Adults
A study testing Whole body vibration training in people with Obesity and Weight Gain, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the benefits and feasibility of a whole body vibration (WBV) exercise program as a method of preventing weight gain in young adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Gain
- What is being tested?
- Whole body vibration training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Nov 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI that is between 22-29.9 kg/m2
- History of being weight stable (± 2 kg) for three months prior to beginning the intervention
- Not currently on a prescribed diet plan to lose weight and no plan to begin one
- Not consistently engaged in physical activity that meets current public health recommendations of 150 minutes of moderate to vigorous physical activity in the previous 6 months
- Currently enrolled as an undergraduate student in a degree-granting college or university
- Planning to reside in the Portland Metro area for the duration of the study
Who cannot join
- Health condition that would prevent participation in moderate intensity physical activity program.
- For female participants, pregnancy or plans to become pregnant during the study period (source documentation: self-report on HHQ)
- Currently smoking/tobacco products or initiation of smoking/tobacco during the study
- Alcohol consumption exceeding 3 drinks per day or a total of 18 drinks per week
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the benefits and feasibility of a whole body vibration (WBV) exercise program as a method of preventing weight gain in young adults.
- Conditions
- Obesity, Weight Gain
- Being tested
- Whole body vibration training, Control group
- Keywords
- whole body vibration training, young adult, weight gain, obesity, randomized clinical trial
- Medical subject headings
- Obesity, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibration trainingBehavioural
Each whole body vibration session will consist of a 20 min timed stand on the vibration platform where participants will stand with their knees in a slightly flexed position (120°) while the plate oscillates. The vibration frequency will be set at ranges between 20-40Hz and the amplitude set at 2mm displacement.
Control groupBehavioural
Participants in this group will be asked to not make any significant changes to their lifestyle behaviors, such as diet and exercise, for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration training | Experimental | Whole body vibration training (timed stand on vibration platform) 3 20-minute sessions per week for 6 months Receives: Behavioral: Whole body vibration training |
| Control group | Placebo comparator | No significant changes to diet, exercise and lifestyle. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body composition (total body mass, fat-free mass, fat mass, regional fat mass, android/gynoid ratio and % body fat) across baseline, 3 and 6 months
Measured: baseline, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startJul 2015
- Primary completionAug 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerri Winters, Oregon Health and Science University
- Investigators
- Kerri Winters-Stone, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134275
- Sponsor's protocol ID
- 10504
- Status last verified
- Nov 2018
- First submitted
- 6 May 2014
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Vibration Training for Healthy Body Composition in Young Adults
- ClinicalTrials.gov ID
- NCT02134275
- Acronym / sponsor ID
- 10504
- Conditions
- Obesity, Weight Gain
- Keywords
- whole body vibration training, young adult, weight gain, obesity, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 9 May 2014 (estimated)
- 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.
The purpose of this study is to evaluate the benefits and feasibility of a whole body vibration (WBV) exercise program as a method of preventing weight gain in young adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration training | Experimental | Behavioral: Whole body vibration trainingWhole body vibration training (timed stand on vibration platform) 3 20-minute sessions per week for 6 months |
| Control group | Placebo comparator | Behavioral: Control groupNo significant changes to diet, exercise and lifestyle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI that is between 22-29.9 kg/m2
- History of being weight stable (± 2 kg) for three months prior to beginning the intervention
- Not currently on a prescribed diet plan to lose weight and no plan to begin one
- Not consistently engaged in physical activity that meets current public health recommendations of 150 minutes of moderate to vigorous physical activity in the previous 6 months
- Currently enrolled as an undergraduate student in a degree-granting college or university
Key exclusion criteria (4 listed)
- Health condition that would prevent participation in moderate intensity physical activity program.
- For female participants, pregnancy or plans to become pregnant during the study period (source documentation: self-report on HHQ)
- Currently smoking/tobacco products or initiation of smoking/tobacco during the study
- Alcohol consumption exceeding 3 drinks per day or a total of 18 drinks per week
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 |
|---|---|---|
| Whole body vibration trainingEach whole body vibration session will consist of a 20 min timed stand on the vibration platform where participants will stand with their knees in a slightly flexed position (120°) while the plate oscillates. The vibration frequency will be set at ranges between 20-40Hz and the amplitude set at 2mm displacement. | Behavioural | Whole body vibration training |
| Control groupParticipants in this group will be asked to not make any significant changes to their lifestyle behaviors, such as diet and exercise, for the duration of the study. | Behavioural | Control group |
Primary outcome
Change in body composition (total body mass, fat-free mass, fat mass, regional fat mass, android/gynoid ratio and % body fat) across baseline, 3 and 6 months
Time frame: baseline, 3, 6 months
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 23 Nov 2018.
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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.
Kerri Winters-Stone, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body vibration training in people with Obesity and Weight Gain, run by Oregon Health and Science University at 1 site in United States.
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 4 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 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Change in body composition (total body mass, fat-free mass, fat mass, regional fat mass, android/gynoid ratio and % body fat) across baseline, 3 and 6 months (time frame: baseline, 3, 6 months). 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 23 Nov 2018.