CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 37 enrolled
Drug / intervention
Vest +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02239939
NCT02239939N/ACompleted

Weighted Vest Use to Preserve Muscle and Bone During Obesity Treatment for Osteoarthritis

Wake Forest University Health Sciences·interventional·Posted Sep 15, 2014·Updated Mar 9, 2018

In Brief

A clinical study evaluating Vest and Diet for Obesity and Osteoarthritis. Completed, enrolled 37 participants across 1 site.

Detailed Summary

The purpose of this research study is to see whether wearing a weighted vest during a period of active weight loss can decrease the loss of muscle and bone that occurs during weight loss. We will also determine if study participants who wear the weighted vest will have greater improvements in physical function and self-reported disability, pain, stiffness, fatigue and quality of life. This knowledge could impact weight loss programs designed for older adults. Hypothesis: Participants randomized to VEST will experience similar weight loss, but less loss of lean mass and bone density, than participants randomized to Control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMedifast, Inc.

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 15, 2014
Enrollment StartOct 1, 2014
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.8 years ago

Interventions

Vestbehavioral

light weight, adjustable, vest to be worn underneath clothes that weight can be added to

Dietbehavioral

Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.