Incorporating Nutrition, Vests, Education, and Strength Training in Bone Health (INVEST in Bone Health)

NCT04076618 | Completed Results FDA Device

• 1 other identifier: IRB00058279
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of the proposed study is to compare the effects of weight loss (WL) alone with WL plus weighted vest use or WL plus resistance exercise training (RT) on indicators of bone health and subsequent fracture risk.

Conditions

Weight Loss; Bone Health

Keywords

nutrition; vest

Outcome Measures

Primary Outcomes (1)

• Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD)

  measured in mg/cm3 during computed tomography (CT) scan

  12 months from baseline

Secondary Outcomes (19)

• Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD)

  6 months from baseline

• Change in Femoral Neck Volumetric Bone Mineral Density (vBMD)

  6 months from baseline

• Change in Femoral Neck Volumetric Bone Mineral Density (vBMD)

  12 months from baseline

• Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD)

  6 months from baseline

• Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD)

  12 months from baseline

Other Outcomes (23)

• Mid-thigh Muscle Density Measured in Hounsfield Units (HU)

  12 months from baseline

• Mid- Thigh Intermuscular Fat Cross Sectional Area (CSA) (cm2)

  12 months from baseline

• Cortical Thickness (mm)

  12 months from baseline

Study Arms (3)

Weight Loss plus Vest

EXPERIMENTAL

Device: Vest; Behavioral: weight loss program

Weight Loss Plus Resistance Exercise Training

ACTIVE COMPARATOR

Behavioral: Resistance Exercise Training; Behavioral: weight loss program

Weight Loss

ACTIVE COMPARATOR

Behavioral: weight loss program

Interventions

Vest DEVICE

Weighted Vest worn \> or = 8 hours per day

Weight Loss plus Vest

Resistance Exercise Training BEHAVIORAL

Structured exercise training 3 days a week

Weight Loss Plus Resistance Exercise Training

weight loss program BEHAVIORAL

a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)

Weight Loss; Weight Loss Plus Resistance Exercise Training; Weight Loss plus Vest

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60-85 years
• BMI=30-40 kg/m\^2 or BMI 27.0-\<30.0 kg/m\^2 plus one risk factor
• Weight stability - no weight loss \> 5% in past 6 months
• No contraindications for safe and optimal participation in exercise training/vest use.
• Approved for participation by Study Coordinator
• Willing to provide informed consent; agree to all study procedures and assessments; Able to provide own transit to assessment/intervention visits
• Willing to complete online/electronic study forms and participate in virtual group sessions, as needed.

You may not qualify if:

• Weight greater than 450 lbs
• Dependent on cane or walker: \>2 falls (injurious on non-injurious) in past year
• Any contraindications for participation in voluntary weight loss
• Smoker (\>1 cigarette/d or 4/wk within yr); Excessive alcohol use (\>14 drinks/wk)
• Participation in regular resistance training and/or high intensity/high impact aerobic exercise for \>60 mins per day on \> 5 days/week for the past 6 months
• Evidence of cognitive impairment (MoCA\<20)
• Osteoporosis (self-report and on prescription medication, T-score \< or = -2.5 on total hip, femoral neck, lumbar spine or distal radius scan at screening visit, or fracture risk assessment tool (FRAX) 10-year risk scores \>3% for hip fracture or \>20% for major osteoporotic fracture (TBS adjusted FRAX is preferable if available)
• Self-reported prior spine, hip, wrist, or shoulder fracture after age 40 (except when caused by trauma or fall from height)
• Chronic back/shoulder/knee pain with current or past (within 1 year) prescription medication use for at least 3 months
• Severe, diagnosed arthritis (osteoarthritis, rheumatoid arthritis, or gout) with current or past (within 1 year) prescription medication use for at least 3 months
• Past (ever) or planned (next 12 months) back surgery
• Past (6 months prior) or planned (next 12 months) joint replacement surgery; or past (ever) unilateral or bilateral hip replacement surgery
• Past (ever) metal device or fixation in the hip, pelvis, or femur
• Uncontrolled hypertension (BP \> 160/90 mmHg)
• Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease requiring oxygen, neurological or hematological disease requiring treatment for at least 3 months in past year

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (3)

• Beavers KM, Lynch SD, Fanning J, Howard M, Lawrence E, Lenchik L, Shapses SA, Weaver AA, Wherry SJ, Zamora Z, Nicklas BJ, Beavers DP. Weighted Vest Use or Resistance Exercise to Offset Weight Loss-Associated Bone Loss in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2516772. doi: 10.1001/jamanetworkopen.2025.16772.

  PMID: 40540267 DERIVED

• Beavers KM, Avery AE, Shankaran M, Evans WJ, Lynch SD, Dwyer C, Howard M, Beavers DP, Weaver AA, Lenchik L, Cawthon PM. Application of the D3 -creatine muscle mass assessment tool to a geriatric weight loss trial: A pilot study. J Cachexia Sarcopenia Muscle. 2023 Oct;14(5):2350-2358. doi: 10.1002/jcsm.13322. Epub 2023 Sep 5.

  PMID: 37668075 DERIVED

• Miller RM, Beavers DP, Cawthon PM, Crotts C, Fanning J, Gerosa J, Greene KA, Hsieh KL, Kiel J, Lawrence E, Lenchik L, Lynch SD, Nesbit BA, Nicklas BJ, Weaver AA, Beavers KM. Incorporating Nutrition, Vests, Education, and Strength Training (INVEST) in Bone Health: Trial Design and Methods. Contemp Clin Trials. 2021 May;104:106326. doi: 10.1016/j.cct.2021.106326. Epub 2021 Feb 22.

  PMID: 33631359 DERIVED

MeSH Terms

Conditions

Weight Loss

Interventions

Resistance Training; Weight Reduction Programs

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Promotion; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Kristen Beavers, PhD, MPH, RD
• Organization: Wake Forest University School of Medicine

kbeavers@wakehealth.edu

336-758-5855

Study Officials

• Kristen Beavers, PhD, MPH, RD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: August 12, 2020
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)