Weight Loss, Bone Health
Conditions
Keywords
nutrition, vest
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.
Detailed description
The study team proposes that a 12 month trial in 150 older (60-85 years) adults with obesity (Body mass index or BMI=30-40 kg/m2 OR 27.0-\<30 kg/m² and one obesity-related risk factor) randomized to one of three interventions (n=50/group): WL alone (WL; caloric restriction targeting 10% WL); WL plus weighted vest use (WL+Vest); targeting ≥8 hours/day, weight replacement titrated up to 10% WL); or, WL plus structured RT (WL+RT; 3 days/week). Total hip trabecular volumetric bone mineral density (vBMD) is the primary outcome. This outcome will be complemented by exploratory assessment of several fracture-related risk factors, including: (1) femoral neck and lumbar spine vBMD, cortical thickness, finite element modeling of bone strength, and regional fat and muscle volumes, measured by CT; (2) areal bone mineral density (aBMD) at the total hip, femoral neck, lumbar spine, and distal radius; trabecular bone score; and total body fat/lean masses, measured by dual energy x-ray absorptiometry (DXA); (3) muscle function and strength; (4) biomarkers of bone turnover; and (5) bone-regulating hormones/cytokines known to influence bone metabolism during WL. Therefore, the investigators Specific Aims are to: Aim 1: Determine the effects of WL+Vest compared to WL and WL+RT on 12 month change in total hip trabecular vBMD. Despite similar reductions in total body weight, Hypothesis 1: Participants in the WL+Vest group will show attenuated losses of total hip trabecular vBMD versus WL; and Hypothesis 2: Loss in total hip trabecular vBMD will be no greater in WL+Vest compared to WL+RT. Aim 2: Explore the effects of WL+Vest compared to WL and WL+RT on the 12 month change in fracture-related risk factors. Despite similar reductions in total body weight, we hypothesize that WL+Vest and WL+RT will demonstrate improvements in fracture-related risk factors compared to WL.
Interventions
DEVICEVest
Weighted Vest worn \> or = 8 hours per day
BEHAVIORALResistance Exercise Training
Structured exercise training 3 days a week
BEHAVIORALweight loss program
a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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.
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\<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 * Cancer requiring treatment in past year, except non-melanoma skin cancer * Low Vitamin D (\<20 ng/mL) * Abnormal kidney or liver function (2x upper limits of normal) * estimated glomerular filtration rate (eGFR)\<45 mL/min/1.73m2, * Anemia (Hb \<13 g/dL in men/\<12 g/dL in women) * Uncontrolled diabetes (fasting glucose \> 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD) | 12 months from baseline | measured in mg/cm3 during computed tomography (CT) scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD) | 6 months from baseline | measured in mg/cm3 during computed tomography (CT) scan |
| Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD) | 6 months from baseline | measured in mg/cm3 during computed tomography (CT) scan |
| Change in Trabecular Bone Score (TBS) | 6 months from baseline | 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. |
| Change in Total Hip Areal Bone Mineral Density (aBMD) | 6 months from baseline | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan |
| Change in Femoral Neck Volumetric Bone Mineral Density (vBMD) | 6 months from baseline | measured in mg/cm3 during computed tomography (CT) scan |
| Change in Distal Radius Areal Bone Mineral Density (aBMD) | 6 months from baseline | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan |
| Change in Lumbar Spine Areal Bone Mineral Density (aBMD) | 6 months from baseline | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan |
| Change in Total Body Fat Mass (kg) | 6 months from baseline | measurement taken during dual energy x-ray absorptiometry (DXA) scan |
| Change in Total Body Lean Mass (kg) | 6 months from baseline | measurement taken during dual energy x-ray absorptiometry (DXA) |
| Change in Femoral Neck Areal Bone Mineral Density (aBMD) | 6 months from baseline | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gait Speed | 12 months from baseline | measured in m/s during the 400 meter walk test |
| Expanded Short Physical Performance Battery (eSPPB) | 12 months from baseline | The SPPB is a measure of balance, walking speed, and ability to stand from a chair. It provides a global measure of overall physical function and is a good predictor of future disability, institutionalization, and mortality in older persons. The SPPB score is calculated by assigning each of the test measures (balance, walking speed, and chair stands) a score from 0 (unable to do) to 4 (best) and then adding these scores together for a total score ranging from 0 to 12. An SPPB score less than 10 identifies persons at higher risk for mobility disability. |
| Timed-Up-and-Go (TUG) | 12 months from baseline | measured in seconds to assess physical performance; measures the time the participant takes to stand up from a standard chair, walk 3 meters, turn, walk back to the chair, and sit down again. |
| Stair Climbing Time | 12 months from baseline | measured in seconds using the participant's fastest time achieved to climb a 12 step staircase in two trials. |
| Lower Extremity Muscle Strength | 12 months from baseline | measured using an isokinetic dynamometer with the participant sitting and the hips and knee flexed at 90°. Participants will be asked to extend the knee and push as hard as possible against the resistance pad. Strength is expressed as peak torque (Nm) |
| Grip Strength | 12 months from baseline | measured twice in each hand to the nearest two kg using an isometric Jamar Hydraulic Hand Dynamometer with the mean value from the stronger hand used |
| Mid-thigh Muscle Density Measured in Hounsfield Units (HU) | 12 months from baseline | measurement taken during computed tomography (CT) scan |
| Fatigability | 12 months from baseline | measured using the Pittsburgh Fatigability scale, which is a 10-item questionnaire that assesses fatigability, or the rate at which a person experiences mental or physical fatigue in the context of a standardized task. The scale ranges from 0-5, where those who exhibit more fatigability, score of 5, are more likely to limit activities of daily living and to reduce exertion during physical activities. |
| Pain and Fatigue | 12 months from baseline | measured using The Patient-Reported Outcomes Measurement Information System (PROMIS) instrument is an 8-item short-form that assesses pain and fatigue over the past 7 days. The scale ranges from 1-5, with higher scores indicated the presence of pain and fatigue. |
| Physical Activity Among Older Adults | 12 months from baseline | The CHAMPS questionnaire is a 40-43-item tool that assesses weekly frequency and duration of a variety of lifestyle physical activities that are appropriate for older adults. The purpose of this questionnaire is to evaluate the effectiveness of interventions to increase lifestyle physical activity among older adults. Physical activities are given a METS score, ranging from 2.0-7.0, where activities with an activities of moderate intensity (METS) score of 3.0 or higher, are considered moderate intensity. |
| Overall Limb Loading | 6 months from baseline | measured in Newtons via force-sensing insoles to assess overall limb loading and to determine if participants receive enough loading to prevent bone loss from resistance training and weighted vest use when compared to weight loss alone. |
| Overall Satisfaction Participating in the Optional Insole Visits | 6 months from baseline | overall satisfaction measured by a scale from 1-5 with a higher score indicating greater satisfaction |
| Cognitive Assessment | 12 months from baseline | measured using the Montreal Cognitive Assessment (MOCA) with scores ranging from 0-30, with a score of 26 and higher generally considered normal. |
| Mid- Thigh Intermuscular Fat Cross Sectional Area (CSA) (cm2) | 12 months from baseline | measurement taken during computed tomography (CT) scan |
| Cortical Thickness (mm) | 12 months from baseline | measurement taken during computed tomography (CT) scan |
| Finite Element (FE) Modeling of Bone Strength Measured in Kilonewton (kN) | 12 months from baseline | measurement taken during computed tomography (CT) scan |
| Mid-thigh Muscle CSA (cm2) | 12 months from baseline | measurement taken during computed tomography (CT) scan |
| L3 Muscle Density Measured in HU | 12 months from baseline | measurement taken during computed tomography (CT) scan |
| L3 Intermuscular Fat CSA (cm2) | 12 months from baseline | measurement taken during computed tomography (CT) scan |
| L3 Muscle CSA (cm2) | 12 months from baseline | measurement taken during computed tomography (CT) scan |
| Concentration of Procollagen 1 Intact N-Terminal Propeptide (P1NP) (ug/L) | 12 months from baseline | Biomarkers of bone turnover measured via blood specimen |
| Concentration of C-terminal Telopeptide (CTX) (pg/mL) | 12 months from baseline | Biomarkers of bone turnover measured via blood specimen |
| D3-Creatine Derived Muscle Mass Measured in kg | 12 months from baseline | measurement taken via urine sample |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Weight Loss Plus Vest Vest: Weighted Vest worn \> or = 8 hours per day
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes) | 50 |
| Weight Loss Plus Resistance Exercise Training Resistance Exercise Training: Structured exercise training 3 days a week
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes) | 50 |
| Weight Loss weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes) | 50 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 2 |
| Overall Study | COVID concerns | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 | 3 |
| Overall Study | Relocated out of state | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 2 |
Baseline characteristics
| Characteristic | Weight Loss | Weight Loss Plus Resistance Exercise Training | Weight Loss Plus Vest | Total |
|---|---|---|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 4.2 | 66.4 years STANDARD_DEVIATION 5.1 | 66.9 years STANDARD_DEVIATION 4.5 | 66.4 years STANDARD_DEVIATION 4.6 |
| Body Mass Index | 33.4 kg/m2 STANDARD_DEVIATION 3.3 | 33.6 kg/m2 STANDARD_DEVIATION 3 | 33.8 kg/m2 STANDARD_DEVIATION 3.7 | 33.6 kg/m2 STANDARD_DEVIATION 3.3 |
| Body Mass Index (kg/m2) | 92.3 Kilograms STANDARD_DEVIATION 14.3 | 92.7 Kilograms STANDARD_DEVIATION 11.9 | 93.6 Kilograms STANDARD_DEVIATION 12.3 | 92.9 Kilograms STANDARD_DEVIATION 12.8 |
| Comorbidities Arthritis/Joint Pain | 36 Participants | 29 Participants | 39 Participants | 104 Participants |
| Comorbidities Cardiovascular Disease | 6 Participants | 6 Participants | 4 Participants | 16 Participants |
| Comorbidities Diabetes | 6 Participants | 1 Participants | 5 Participants | 12 Participants |
| Education College | 31 Participants | 27 Participants | 23 Participants | 81 Participants |
| Education High School Equivalent | 8 Participants | 7 Participants | 13 Participants | 28 Participants |
| Education Post Graduate | 11 Participants | 16 Participants | 14 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 49 Participants | 49 Participants | 147 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fast Gait Speed | 1.3 Meters Per Second STANDARD_DEVIATION 0.1 | 1.3 Meters Per Second STANDARD_DEVIATION 0.2 | 1.3 Meters Per Second STANDARD_DEVIATION 0.2 | 1.3 Meters Per Second STANDARD_DEVIATION 0.2 |
| Height | 166.0 Centimeters STANDARD_DEVIATION 8.8 | 166.0 Centimeters STANDARD_DEVIATION 8 | 166.5 Centimeters STANDARD_DEVIATION 8.5 | 166.2 Centimeters STANDARD_DEVIATION 8.4 |
| Low Bone Mass | 26 Participants | 23 Participants | 24 Participants | 73 Participants |
| Moderate Intensity Physical Activity | 0 Minutes Per Week | 45 Minutes Per Week | 30 Minutes Per Week | 30 Minutes Per Week |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 15 Participants | 16 Participants | 43 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 35 Participants | 33 Participants | 103 Participants |
| Sex: Female, Male Female | 37 Participants | 38 Participants | 37 Participants | 112 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 13 Participants | 38 Participants |
| Total Physical Activity | 2042 Kilocalories Per Week | 2144 Kilocalories Per Week | 1941 Kilocalories Per Week | 2029 Kilocalories Per Week |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 23 / 50 | 22 / 50 | 20 / 50 |
| serious Total, serious adverse events | 3 / 50 | 1 / 50 | 2 / 50 |
Outcome results
Primary
Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD)
measured in mg/cm3 during computed tomography (CT) scan
Time frame: 12 months from baseline
Population: 6 participants in Weight Loss Plus Vest arm did not complete a CT scan. 5 participants in Weight Loss Plus Resistance Exercise Training arm did not complete a scan. 7 participants in Weight Loss arm did not complete scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD) | -0.002 mg/cm3 |
| Weight Loss Plus Resistance Exercise Training | Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD) | -0.002 mg/cm3 |
| Weight Loss | Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD) | -0.003 mg/cm3 |
Secondary
Change in Distal Radius Areal Bone Mineral Density (aBMD)
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Time frame: 12 months from baseline
Population: 5 participants in the Weight Loss Plus Vest arm did not complete DXA scan. 5 participants in the Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 7 participants in the Weight Loss arm did not complete DXA scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Distal Radius Areal Bone Mineral Density (aBMD) | -0.013 g/cm2 |
| Weight Loss Plus Resistance Exercise Training | Change in Distal Radius Areal Bone Mineral Density (aBMD) | -0.007 g/cm2 |
| Weight Loss | Change in Distal Radius Areal Bone Mineral Density (aBMD) | -0.013 g/cm2 |
Secondary
Change in Distal Radius Areal Bone Mineral Density (aBMD)
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Time frame: 6 months from baseline
Population: 3 participants in the Weight Loss Plus Vest arm did not complete DXA scan. 3 participants in the Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 5 participants in the Weight Loss arm did not complete DXA scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Distal Radius Areal Bone Mineral Density (aBMD) | -0.009 g/cm2 |
| Weight Loss Plus Resistance Exercise Training | Change in Distal Radius Areal Bone Mineral Density (aBMD) | -0.008 g/cm2 |
| Weight Loss | Change in Distal Radius Areal Bone Mineral Density (aBMD) | -0.007 g/cm2 |
Secondary
Change in Femoral Neck Areal Bone Mineral Density (aBMD)
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Time frame: 12 months from baseline
Population: 5 participants in Weight Loss Plus Vest arm did not complete DXA scan. 5 participants in Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 7 participants in Weight Loss arm did not complete DXA scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Femoral Neck Areal Bone Mineral Density (aBMD) | -0.006 g/cm2 |
| Weight Loss Plus Resistance Exercise Training | Change in Femoral Neck Areal Bone Mineral Density (aBMD) | -0.004 g/cm2 |
| Weight Loss | Change in Femoral Neck Areal Bone Mineral Density (aBMD) | -0.005 g/cm2 |
Secondary
Change in Femoral Neck Areal Bone Mineral Density (aBMD)
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Time frame: 6 months from baseline
Population: 3 participants in Weight Loss Plus Vest arm did not complete DXA scan. 3 participants in Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 5 participants in Weight Loss arm did not complete DXA scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Femoral Neck Areal Bone Mineral Density (aBMD) | -0.000 g/cm2 |
| Weight Loss Plus Resistance Exercise Training | Change in Femoral Neck Areal Bone Mineral Density (aBMD) | 0.004 g/cm2 |
| Weight Loss | Change in Femoral Neck Areal Bone Mineral Density (aBMD) | 0.004 g/cm2 |
Secondary
Change in Femoral Neck Volumetric Bone Mineral Density (vBMD)
measured in mg/cm3 during computed tomography (CT) scan
Time frame: 6 months from baseline
Population: 4 participants in Weight Loss Plus Vest arm did not complete a CT scan. 4 participants in Weight Loss Plus Resistance Exercise Training arm did not complete a scan. 6 participants in Weight Loss arm did not complete scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Femoral Neck Volumetric Bone Mineral Density (vBMD) | -0.001 mg/cm3 |
| Weight Loss Plus Resistance Exercise Training | Change in Femoral Neck Volumetric Bone Mineral Density (vBMD) | -0.001 mg/cm3 |
| Weight Loss | Change in Femoral Neck Volumetric Bone Mineral Density (vBMD) | -0.001 mg/cm3 |
Secondary
Change in Femoral Neck Volumetric Bone Mineral Density (vBMD)
measured in mg/cm3 during computed tomography (CT) scan
Time frame: 12 months from baseline
Population: 6 participants in Weight Loss Plus Vest arm did not complete a CT scan. 5 participants in Weight Loss Plus Resistance Exercise Training arm did not complete a scan. 7 participants in Weight Loss arm did not complete scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Femoral Neck Volumetric Bone Mineral Density (vBMD) | -0.002 mg/cm3 |
| Weight Loss Plus Resistance Exercise Training | Change in Femoral Neck Volumetric Bone Mineral Density (vBMD) | -0.003 mg/cm3 |
| Weight Loss | Change in Femoral Neck Volumetric Bone Mineral Density (vBMD) | -0.004 mg/cm3 |
Secondary
Change in Lumbar Spine Areal Bone Mineral Density (aBMD)
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Time frame: 6 months from baseline
Population: 3 participants in Weight Loss Plus Vest arm did not complete DXA scan. 3 participants in Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 5 participants in Weight Loss arm did not complete DXA scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Lumbar Spine Areal Bone Mineral Density (aBMD) | 0.003 g/cm2 |
| Weight Loss Plus Resistance Exercise Training | Change in Lumbar Spine Areal Bone Mineral Density (aBMD) | 0.015 g/cm2 |
| Weight Loss | Change in Lumbar Spine Areal Bone Mineral Density (aBMD) | 0.016 g/cm2 |
Secondary
Change in Lumbar Spine Areal Bone Mineral Density (aBMD)
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Time frame: 12 months from baseline
Population: 5 participants in Weight Loss Plus Vest arm did not complete DXA scan. 5 participants in Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 7 participants in Weight Loss arm did not complete DXA scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Lumbar Spine Areal Bone Mineral Density (aBMD) | 0.006 g/cm2 |
| Weight Loss Plus Resistance Exercise Training | Change in Lumbar Spine Areal Bone Mineral Density (aBMD) | 0.011 g/cm2 |
| Weight Loss | Change in Lumbar Spine Areal Bone Mineral Density (aBMD) | 0.010 g/cm2 |
Secondary
Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD)
measured in mg/cm3 during computed tomography (CT) scan
Time frame: 6 months from baseline
Population: 3 participants in Weight Loss Plus Vest arm did not complete the scan. 4 participants in Weight Loss Plus Resistance Exercise Training arm did not complete the scan. 5 participants in the Weight Loss arm did not complete the scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD) | 0.001 mg/cm3 |
| Weight Loss Plus Resistance Exercise Training | Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD) | 0.005 mg/cm3 |
| Weight Loss | Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD) | 0.005 mg/cm3 |
Secondary
Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD)
measured in mg/cm3 during computed tomography (CT) scan
Time frame: 12 months from baseline
Population: 5 participants in Weight Loss Plus Vest arm did not complete the scan. 5 participants in Weight Loss Plus Resistance Exercise Training arm did not complete the scan. 7 participants in the Weight Loss arm did not complete the scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD) | -0.000 mg/cm3 |
| Weight Loss Plus Resistance Exercise Training | Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD) | 0.003 mg/cm3 |
| Weight Loss | Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD) | 0.000 mg/cm3 |
Secondary
Change in Total Body Fat Mass (kg)
measurement taken during dual energy x-ray absorptiometry (DXA) scan
Time frame: 12 months from baseline
Population: 5 participants in Weight Loss Plus Vest arm did not complete DXA scan. 5 participants in Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 7 participants in Weight Loss arm did not complete DXA scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Total Body Fat Mass (kg) | -7.3 kg |
| Weight Loss Plus Resistance Exercise Training | Change in Total Body Fat Mass (kg) | -10.0 kg |
| Weight Loss | Change in Total Body Fat Mass (kg) | -7.7 kg |
Secondary
Change in Total Body Fat Mass (kg)
measurement taken during dual energy x-ray absorptiometry (DXA) scan
Time frame: 6 months from baseline
Population: 3 participants in Weight Loss Plus Vest arm did not complete DXA scan. 3 participants in Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 5 participants in Weight Loss arm did not complete DXA scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Total Body Fat Mass (kg) | -7.8 kg |
| Weight Loss Plus Resistance Exercise Training | Change in Total Body Fat Mass (kg) | -8.8 kg |
| Weight Loss | Change in Total Body Fat Mass (kg) | -7.8 kg |
Secondary
Change in Total Body Lean Mass (kg)
measurement taken during dual energy x-ray absorptiometry (DXA)
Time frame: 12 months from baseline
Population: 5 participants in Weight Loss Plus Vest arm did not complete DXA scan. 5 participants in Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 7 participants in Weight Loss arm did not complete DXA scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Total Body Lean Mass (kg) | -0.7 kg |
| Weight Loss Plus Resistance Exercise Training | Change in Total Body Lean Mass (kg) | -0.9 kg |
| Weight Loss | Change in Total Body Lean Mass (kg) | -0.9 kg |
Secondary
Change in Total Body Lean Mass (kg)
measurement taken during dual energy x-ray absorptiometry (DXA)
Time frame: 6 months from baseline
Population: 3 participants in Weight Loss Plus Vest arm did not complete DXA scan. 3 participants in Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 5 participants in Weight Loss arm did not complete DXA scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Total Body Lean Mass (kg) | -0.5 kg |
| Weight Loss Plus Resistance Exercise Training | Change in Total Body Lean Mass (kg) | -0.8 kg |
| Weight Loss | Change in Total Body Lean Mass (kg) | -0.7 kg |
Secondary
Change in Total Hip Areal Bone Mineral Density (aBMD)
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Time frame: 6 months from baseline
Population: 3 participants in Weight Loss Plus Vest did not complete DXA scan. 3 participants in Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 5 participants in Weight Loss arm did not complete DXA scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Total Hip Areal Bone Mineral Density (aBMD) | -0.006 g/cm2 |
| Weight Loss Plus Resistance Exercise Training | Change in Total Hip Areal Bone Mineral Density (aBMD) | -0.008 g/cm2 |
| Weight Loss | Change in Total Hip Areal Bone Mineral Density (aBMD) | -0.008 g/cm2 |
Secondary
Change in Total Hip Areal Bone Mineral Density (aBMD)
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Time frame: 12 months from baseline
Population: 5 participants in Weight Loss Plus Vest did not complete DXA scan. 5 participants in Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 7 participants in Weight Loss arm did not complete DXA scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Total Hip Areal Bone Mineral Density (aBMD) | -0.015 g/cm2 |
| Weight Loss Plus Resistance Exercise Training | Change in Total Hip Areal Bone Mineral Density (aBMD) | -0.016 g/cm2 |
| Weight Loss | Change in Total Hip Areal Bone Mineral Density (aBMD) | -0.017 g/cm2 |
Secondary
Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD)
measured in mg/cm3 during computed tomography (CT) scan
Time frame: 6 months from baseline
Population: 4 participants in Weight Loss Plus Vest arm did not complete a CT scan. 4 participants in Weight Loss Plus Resistance Exercise Training arm did not complete a scan. 6 participants in Weight Loss arm did not complete scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD) | -0.001 mg/cm3 |
| Weight Loss Plus Resistance Exercise Training | Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD) | -0.000 mg/cm3 |
| Weight Loss | Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD) | -0.000 mg/cm3 |
Secondary
Change in Trabecular Bone Score (TBS)
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.
Time frame: 12 months from baseline
Population: 5 participants in Weight Loss Plus Vest arm did not complete DXA scan. 5 participants in Weight Loss Plus Resistance Exercise Training Arm did not complete DXA scan. 7 participants in Weight Loss arm did not complete DXA scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Trabecular Bone Score (TBS) | 0.014 score on a scale |
| Weight Loss Plus Resistance Exercise Training | Change in Trabecular Bone Score (TBS) | 0.037 score on a scale |
| Weight Loss | Change in Trabecular Bone Score (TBS) | 0.017 score on a scale |
Secondary
Change in Trabecular Bone Score (TBS)
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.
Time frame: 6 months from baseline
Population: 3 participants in Weight Loss Plus Vest arm did not complete DXA scan. 3 participants in Weight Loss Plus Resistance Exercise Training Arm did not complete DXA scan. 5 participants in Weight Loss arm did not complete DXA scan.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Loss Plus Vest | Change in Trabecular Bone Score (TBS) | 0.020 score on a scale |
| Weight Loss Plus Resistance Exercise Training | Change in Trabecular Bone Score (TBS) | 0.037 score on a scale |
| Weight Loss | Change in Trabecular Bone Score (TBS) | 0.017 score on a scale |
Other Pre-specified
Cognitive Assessment
measured using the Montreal Cognitive Assessment (MOCA) with scores ranging from 0-30, with a score of 26 and higher generally considered normal.
Time frame: 12 months from baseline
Other Pre-specified
Concentration of C-terminal Telopeptide (CTX) (pg/mL)
Biomarkers of bone turnover measured via blood specimen
Time frame: 12 months from baseline
Other Pre-specified
Concentration of Procollagen 1 Intact N-Terminal Propeptide (P1NP) (ug/L)
Biomarkers of bone turnover measured via blood specimen
Time frame: 12 months from baseline
Other Pre-specified
Cortical Thickness (mm)
measurement taken during computed tomography (CT) scan
Time frame: 12 months from baseline
Other Pre-specified
D3-Creatine Derived Muscle Mass Measured in kg
measurement taken via urine sample
Time frame: 12 months from baseline
Other Pre-specified
Expanded Short Physical Performance Battery (eSPPB)
The SPPB is a measure of balance, walking speed, and ability to stand from a chair. It provides a global measure of overall physical function and is a good predictor of future disability, institutionalization, and mortality in older persons. The SPPB score is calculated by assigning each of the test measures (balance, walking speed, and chair stands) a score from 0 (unable to do) to 4 (best) and then adding these scores together for a total score ranging from 0 to 12. An SPPB score less than 10 identifies persons at higher risk for mobility disability.
Time frame: 12 months from baseline
Other Pre-specified
Fatigability
measured using the Pittsburgh Fatigability scale, which is a 10-item questionnaire that assesses fatigability, or the rate at which a person experiences mental or physical fatigue in the context of a standardized task. The scale ranges from 0-5, where those who exhibit more fatigability, score of 5, are more likely to limit activities of daily living and to reduce exertion during physical activities.
Time frame: 12 months from baseline
Other Pre-specified
Finite Element (FE) Modeling of Bone Strength Measured in Kilonewton (kN)
measurement taken during computed tomography (CT) scan
Time frame: 12 months from baseline
Other Pre-specified
Gait Speed
measured in m/s during the 400 meter walk test
Time frame: 12 months from baseline
Other Pre-specified
Grip Strength
measured twice in each hand to the nearest two kg using an isometric Jamar Hydraulic Hand Dynamometer with the mean value from the stronger hand used
Time frame: 12 months from baseline
Other Pre-specified
L3 Intermuscular Fat CSA (cm2)
measurement taken during computed tomography (CT) scan
Time frame: 12 months from baseline
Other Pre-specified
L3 Muscle CSA (cm2)
measurement taken during computed tomography (CT) scan
Time frame: 12 months from baseline
Other Pre-specified
L3 Muscle Density Measured in HU
measurement taken during computed tomography (CT) scan
Time frame: 12 months from baseline
Other Pre-specified
Lower Extremity Muscle Strength
measured using an isokinetic dynamometer with the participant sitting and the hips and knee flexed at 90°. Participants will be asked to extend the knee and push as hard as possible against the resistance pad. Strength is expressed as peak torque (Nm)
Time frame: 12 months from baseline
Other Pre-specified
Mid- Thigh Intermuscular Fat Cross Sectional Area (CSA) (cm2)
measurement taken during computed tomography (CT) scan
Time frame: 12 months from baseline
Other Pre-specified
Mid-thigh Muscle CSA (cm2)
measurement taken during computed tomography (CT) scan
Time frame: 12 months from baseline
Other Pre-specified
Mid-thigh Muscle Density Measured in Hounsfield Units (HU)
measurement taken during computed tomography (CT) scan
Time frame: 12 months from baseline
Other Pre-specified
Overall Limb Loading
measured in Newtons via force-sensing insoles to assess overall limb loading and to determine if participants receive enough loading to prevent bone loss from resistance training and weighted vest use when compared to weight loss alone.
Time frame: 6 months from baseline
Other Pre-specified
Overall Satisfaction Participating in the Optional Insole Visits
overall satisfaction measured by a scale from 1-5 with a higher score indicating greater satisfaction
Time frame: 6 months from baseline
Other Pre-specified
Pain and Fatigue
measured using The Patient-Reported Outcomes Measurement Information System (PROMIS) instrument is an 8-item short-form that assesses pain and fatigue over the past 7 days. The scale ranges from 1-5, with higher scores indicated the presence of pain and fatigue.
Time frame: 12 months from baseline
Other Pre-specified
Physical Activity Among Older Adults
The CHAMPS questionnaire is a 40-43-item tool that assesses weekly frequency and duration of a variety of lifestyle physical activities that are appropriate for older adults. The purpose of this questionnaire is to evaluate the effectiveness of interventions to increase lifestyle physical activity among older adults. Physical activities are given a METS score, ranging from 2.0-7.0, where activities with an activities of moderate intensity (METS) score of 3.0 or higher, are considered moderate intensity.
Time frame: 12 months from baseline
Other Pre-specified
Stair Climbing Time
measured in seconds using the participant's fastest time achieved to climb a 12 step staircase in two trials.
Time frame: 12 months from baseline
Other Pre-specified
Timed-Up-and-Go (TUG)
measured in seconds to assess physical performance; measures the time the participant takes to stand up from a standard chair, walk 3 meters, turn, walk back to the chair, and sit down again.
Time frame: 12 months from baseline