Incorporating Nutrition, Vests, Education, and Strength Training (INVEST) in Bone Health: Trial Design and Methods.

Autor: Miller RM; Department of Internal Medicine-Geriatrics and Gerontology, Wake Forest School of Medicine, Winston-Salem, NC, United States of America., Beavers DP; Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, United States of America., Cawthon PM; Research Institute, California Pacific Medical Center, San Francisco, CA, United States of America; Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, United States of America., Crotts C; Department of Internal Medicine-Geriatrics and Gerontology, Wake Forest School of Medicine, Winston-Salem, NC, United States of America., Fanning J; Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, United States of America., Gerosa J; Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, United States of America., Greene KA; Department of Biomedical Engineering, Wake Forest School of Medicine, Winston-Salem, NC, United States of America., Hsieh KL; Department of Internal Medicine-Geriatrics and Gerontology, Wake Forest School of Medicine, Winston-Salem, NC, United States of America., Kiel J; Department of Scientific and Clinical Affairs, Medifast, Inc., Baltimore, MD, United States of America., Lawrence E; Department of Internal Medicine-Geriatrics and Gerontology, Wake Forest School of Medicine, Winston-Salem, NC, United States of America., Lenchik L; Department of Diagnostic Radiology, Wake Forest School of Medicine, Winston-Salem, NC, United States of America., Lynch SD; Department of Biomedical Engineering, Wake Forest School of Medicine, Winston-Salem, NC, United States of America., Nesbit BA; Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, United States of America., Nicklas BJ; Department of Internal Medicine-Geriatrics and Gerontology, Wake Forest School of Medicine, Winston-Salem, NC, United States of America., Weaver AA; Department of Biomedical Engineering, Wake Forest School of Medicine, Winston-Salem, NC, United States of America., Beavers KM; Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, United States of America. Electronic address: beaverkm@wfu.edu.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2021 May; Vol. 104, pp. 106326. Date of Electronic Publication: 2021 Feb 22.
DOI: 10.1016/j.cct.2021.106326
Abstrakt: Background: Achievement of 5-10% weight loss (WL) among older adults living with obesity considerably improves prognosis of health-related outcomes; however, concomitant declines in bone mineral density (BMD) limit overall benefit by increasing fracture risk. Declines in mechanical loading contribute to WL-associated BMD loss, with pilot data signaling the addition of external weight replacement (via weighted vest use) during intentional WL mitigates bone loss at weight bearing sites to a similar degree as resistance exercise training (RT). Definitive data in support of weighted vest use as a potential strategy to mitigate WL-associated bone loss in this population are needed.
Methods: In the Incorporating Nutrition, Vests, Education, and Strength Training (INVEST) in Bone Health trial (NCT04076618), 192 older adults (60-85 years) who are overweight (BMI ≥ 27 kg/m 2 ) with at least one obesity-related risk factor or obese (BMI = 30-40 kg/m 2 ) will be randomly assigned to participate in one of three 12-month intervention groups: WL alone, WL + weighted vest use (WL + VEST), or WL + RT. The primary aim is to determine the effects of WL + VEST compared to WL alone and WL + RT on indicators of bone health and subsequent fracture risk.
Discussion: Determining effective, translatable strategies that minimize bone loss during intentional WL among older adults holds public health potential. The INVEST in Bone Health trial offers an innovative approach for increasing mechanical stress during intentional WL in the absence of RT. If successful, findings from this study will provide evidence in support of a scalable solution to minimize bone loss during intentional WL among older adults with obesity.
(Copyright © 2021 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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