Last reviewed · How we verify
Incorporating Nutrition, Vests, Education, and Strength Training in Bone Health (INVEST in Bone Health)
NA trial testing Vest in Weight Loss in 150 participants. Completed in 1 April 2024.
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 150 |
| Start date | 12 August 2020 |
| Primary completion | 1 April 2024 |
| Estimated completion | 1 April 2024 |
| Sites | 1 location across United States |
Wake Forest University Health Sciences
Adults 60 to 85, any sex, with Weight Loss or Bone Health. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
measured in mg/cm3 during computed tomography (CT) scan
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss Plus Vest | -0.002 | -0.003 – -0.001 |
| Weight Loss Plus Resistance Exercise Training | -0.002 | -0.003 – -0.001 |
| Weight Loss | -0.003 | -0.003 – -0.002 |
measured in mg/cm3 during computed tomography (CT) scan
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss Plus Vest | -0.001 | -0.001 – 0.000 |
| Weight Loss Plus Resistance Exercise Training | -0.000 | -0.001 – 0.001 |
| Weight Loss | -0.000 | -0.001 – 0.000 |
measured in mg/cm3 during computed tomography (CT) scan
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss Plus Vest | -0.001 | -0.003 – 0.001 |
| Weight Loss Plus Resistance Exercise Training | -0.001 | -0.003 – 0.001 |
| Weight Loss | -0.001 | -0.002 – 0.001 |
measured in mg/cm3 during computed tomography (CT) scan
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss Plus Vest | -0.002 | -0.004 – 0.001 |
| Weight Loss Plus Resistance Exercise Training | -0.003 | -0.005 – -0.000 |
| Weight Loss | -0.004 | -0.007 – -0.002 |
measured in mg/cm3 during computed tomography (CT) scan
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss Plus Vest | 0.001 | -0.002 – 0.005 |
| Weight Loss Plus Resistance Exercise Training | 0.005 | 0.001 – 0.008 |
| Weight Loss | 0.005 | 0.002 – 0.008 |
measured in mg/cm3 during computed tomography (CT) scan
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss Plus Vest | -0.000 | -0.002 – 0.002 |
| Weight Loss Plus Resistance Exercise Training | 0.003 | 0.001 – 0.005 |
| Weight Loss | 0.000 | -0.002 – 0.002 |
measurement taken during dual energy x-ray absorptiometry (DXA) scan; Trabecular Bone Score is a measure of bone architecture that has been shown to be an independent risk factor for fracture. The measure is unitless, and ranges from 1.0-1.6, where an elevated TBS greater than or equal to 1.3 appears to represent strong, fracture-resistant bone architecture, while a low TBS less than or equal to 1.2 reflects weak, fracture-prone bone architecture.
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss Plus Vest | 0.020 | 0.002 – 0.039 |
| Weight Loss Plus Resistance Exercise Training | 0.037 | 0.018 – 0.056 |
| Weight Loss | 0.017 | -0.002 – 0.035 |
measurement taken during dual energy x-ray absorptiometry (DXA) scan; Trabecular Bone Score is a measure of bone architecture that has been shown to be an independent risk factor for fracture. The measure is unitless, and ranges from 1.0-1.6, where an elevated TBS greater than or equal to 1.3 appears to represent strong, fracture-resistant bone architecture, while a low TBS less than or equal to 1.2 reflects weak, fracture-prone bone architecture.
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss Plus Vest | 0.014 | -0.005 – 0.034 |
| Weight Loss Plus Resistance Exercise Training | 0.037 | 0.017 – 0.057 |
| Weight Loss | 0.017 | -0.003 – 0.037 |
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss Plus Vest | -0.006 | -0.013 – 0.001 |
| Weight Loss Plus Resistance Exercise Training | -0.008 | -0.015 – -0.001 |
| Weight Loss | -0.008 | -0.015 – -0.001 |
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss Plus Vest | -0.015 | -0.023 – -0.007 |
| Weight Loss Plus Resistance Exercise Training | -0.016 | -0.024 – -0.008 |
| Weight Loss | -0.017 | -0.025 – -0.009 |
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss Plus Vest | -0.000 | -0.011 – 0.010 |
| Weight Loss Plus Resistance Exercise Training | 0.004 | -0.007 – 0.014 |
| Weight Loss | 0.004 | -0.007 – 0.015 |
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss Plus Vest | -0.006 | -0.017 – 0.005 |
| Weight Loss Plus Resistance Exercise Training | -0.004 | -0.015 – 0.008 |
| Weight Loss | -0.005 | -0.016 – 0.007 |
Time frame: Baseline through Month 12. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Weight Loss Plus Vest | Weight Loss Plus Resistanc… | Weight Loss |
|---|---|---|---|---|
| Small bowel obstruction | Gastrointestinal disorders | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Motor vehicle accident | Social circumstances | — | — | — |
| Prostate transurethral resection | Renal and urinary disorders | — | — | — |
| Retinal detachment | Eye disorders | — | — | — |
| Reaction | System | Weight Loss Plus Vest | Weight Loss Plus Resistanc… | Weight Loss |
|---|---|---|---|---|
| Fall | Social circumstances | — | — | — |
| COVID-19 | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Sinusitis | Infections and infestations | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Urinary tract infection | Renal and urinary disorders | — | — | — |
| Shoulder pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Knee pain | Musculoskeletal and connective tissue disorders | — | — | — |
Most-reported serious reactions: Small bowel obstruction, Back pain, Motor vehicle accident, Prostate transurethral resection, Retinal detachment.
Data from ClinicalTrials.gov NCT04076618 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04076618.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing