NCT02134275

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 6, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

2.1 years

First QC Date

May 6, 2014

Last Update Submit

November 20, 2018

Conditions

ObesityWeight Gain

Keywords

whole body vibration trainingyoung adultweight gainobesityrandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline, 3, 6 months

Study Arms (2)

Whole body vibration training

EXPERIMENTAL

Whole body vibration training (timed stand on vibration platform) 3 20-minute sessions per week for 6 months

Behavioral: Whole body vibration training

Control group

PLACEBO COMPARATOR

No significant changes to diet, exercise and lifestyle.

Behavioral: Control group

Interventions

Whole body vibration trainingBEHAVIORAL

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.

Whole body vibration training
Control groupBEHAVIORAL

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.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU School of Nursing

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

ObesityWeight Gain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Kerri Winters-Stone, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 9, 2014

Study Start

July 1, 2015

Primary Completion

August 1, 2017

Study Completion

November 1, 2017

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations

US(1)