N/A
Completed N=150
Incorporating Nutrition, Vests, Education, and Strength Training in Bone Health (INVEST in Bone Health)
Weight Loss · Bone Health
Source: ClinicalTrials.gov NCT04076618 ↗
Enrolled (actual)
150
Serious AEs
4.0%
Results posted
Feb 2025
Primary outcomePrimary: Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD) — -0.002; -0.002; -0.003 mg/cm3
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD) |
-0.001; -0.000; -0.000 | — |
| SECONDARY Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD) |
-0.001; -0.000; -0.000 | — |
| SECONDARY Change in Femoral Neck Volumetric Bone Mineral Density (vBMD) |
-0.002; -0.003; -0.004 | — |
| SECONDARY Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD) |
-0.000; 0.003; 0.000 | — |
| SECONDARY Change in Trabecular Bone Score (TBS) |
0.014; 0.037; 0.017 | — |
| SECONDARY Change in Total Hip Areal Bone Mineral Density (aBMD) |
-0.015; -0.016; -0.017 | — |
| SECONDARY Change in Femoral Neck Areal Bone Mineral Density (aBMD) |
-0.006; -0.004; -0.005 | — |
| SECONDARY Change in Distal Radius Areal Bone Mineral Density (aBMD) |
-0.013; -0.007; -0.013 | — |
| SECONDARY Change in Lumbar Spine Areal Bone Mineral Density (aBMD) |
0.006; 0.011; 0.010 | — |
| SECONDARY Change in Total Body Fat Mass (kg) |
-7.3; -10.0; -7.7 | — |
| SECONDARY Change in Total Body Lean Mass (kg) |
-0.7; -0.9; -0.9 | — |
Eligibility Criteria
Inclusion Criteria
- Age 60-85 years
- BMI=30-40 kg/m^2 or BMI 27.0- 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.
Exclusion Criteria
- 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 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
- Cancer requiring treatment in past year, except non-melanoma skin cancer
- Low Vitamin D ( 140 mg/dL)
- Regular use of: growth hormones, weight loss medications, oral steroids, insulin, or prescription osteoporosis medications in the past year
- No home computer, laptop or tablet with reliable home internet OR no smartphone (touch-screen enabled phone) with reliable unlimited mobile internet
- Involved in another behavioral/interventional research study, weight loss program, or undergoing physical therapy.
- Unable to tolerate diet, vest, or CT scan (claustrophobia)
- Judged unsuitable for the trial for any reason by clinic staff
Data sourced from ClinicalTrials.gov (NCT04076618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.