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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight Loss plus Vest | Experimental |
| |
| Weight Loss Plus Resistance Exercise Training | Active Comparator |
| |
| Weight Loss | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vest | Device | Weighted Vest worn > or = 8 hours per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD) | measured in mg/cm3 during computed tomography (CT) scan | 12 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD) | measured in mg/cm3 during computed tomography (CT) scan | 6 months from baseline |
| Change in Femoral Neck Volumetric Bone Mineral Density (vBMD) |
| Measure | Description | Time Frame |
|---|---|---|
| Mid-thigh Muscle Density Measured in Hounsfield Units (HU) | measurement taken during computed tomography (CT) scan | 12 months from baseline |
| Mid- Thigh Intermuscular Fat Cross Sectional Area (CSA) (cm2) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen Beavers, PhD, MPH, RD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40540267 | Derived | 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. | |
| 37668075 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| FG002 | 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | Weight Loss Plus Resistance Exercise Training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD) | measured in mg/cm3 during computed tomography (CT) scan | 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. | Posted | Mean | 95% Confidence Interval | mg/cm3 | 12 months from baseline |
|
Baseline through Month 12
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Social circumstances | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen Beavers, PhD, MPH, RD | Wake Forest University School of Medicine | 336-758-5855 | kbeavers@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2022 | Jan 13, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 5, 2024 | Apr 29, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D061217 | Weight Reduction Programs |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Resistance Exercise Training |
| Behavioral |
Structured exercise training 3 days a week |
|
| weight loss program | Behavioral | a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes) |
|
measured in mg/cm3 during computed tomography (CT) scan
| 6 months from baseline |
| Change in Femoral Neck Volumetric Bone Mineral Density (vBMD) | measured in mg/cm3 during computed tomography (CT) scan | 12 months from baseline |
| Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD) | measured in mg/cm3 during computed tomography (CT) scan | 6 months from baseline |
| Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD) | measured in mg/cm3 during computed tomography (CT) scan | 12 months from baseline |
| 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. | 6 months from baseline |
| 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. | 12 months from baseline |
| Change in Total Hip Areal Bone Mineral Density (aBMD) | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan | 6 months from baseline |
| Change in Total Hip Areal Bone Mineral Density (aBMD) | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan | 12 months from baseline |
| Change in Femoral Neck Areal Bone Mineral Density (aBMD) | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan | 6 months from baseline |
| Change in Femoral Neck Areal Bone Mineral Density (aBMD) | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan | 12 months from baseline |
| Change in Distal Radius Areal Bone Mineral Density (aBMD) | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan | 6 months from baseline |
| Change in Distal Radius Areal Bone Mineral Density (aBMD) | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan | 12 months from baseline |
| Change in Lumbar Spine Areal Bone Mineral Density (aBMD) | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan | 6 months from baseline |
| Change in Lumbar Spine Areal Bone Mineral Density (aBMD) | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan | 12 months from baseline |
| Change in Total Body Fat Mass (kg) | measurement taken during dual energy x-ray absorptiometry (DXA) scan | 6 months from baseline |
| Change in Total Body Fat Mass (kg) | measurement taken during dual energy x-ray absorptiometry (DXA) scan | 12 months from baseline |
| Change in Total Body Lean Mass (kg) | measurement taken during dual energy x-ray absorptiometry (DXA) | 6 months from baseline |
| Change in Total Body Lean Mass (kg) | measurement taken during dual energy x-ray absorptiometry (DXA) | 12 months from baseline |
measurement taken during computed tomography (CT) scan
| 12 months from baseline |
| Cortical Thickness (mm) | measurement taken during computed tomography (CT) scan | 12 months from baseline |
| Finite Element (FE) Modeling of Bone Strength Measured in Kilonewton (kN) | measurement taken during computed tomography (CT) scan | 12 months from baseline |
| Mid-thigh Muscle CSA (cm2) | measurement taken during computed tomography (CT) scan | 12 months from baseline |
| L3 Muscle Density Measured in HU | measurement taken during computed tomography (CT) scan | 12 months from baseline |
| L3 Intermuscular Fat CSA (cm2) | measurement taken during computed tomography (CT) scan | 12 months from baseline |
| L3 Muscle CSA (cm2) | measurement taken during computed tomography (CT) scan | 12 months from baseline |
| Concentration of Procollagen 1 Intact N-Terminal Propeptide (P1NP) (ug/L) | Biomarkers of bone turnover measured via blood specimen | 12 months from baseline |
| Concentration of C-terminal Telopeptide (CTX) (pg/mL) | Biomarkers of bone turnover measured via blood specimen | 12 months from baseline |
| D3-Creatine Derived Muscle Mass Measured in kg | measurement taken via urine sample | 12 months from baseline |
| Gait Speed | measured in m/s during the 400 meter walk test | 12 months from baseline |
| 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. | 12 months from baseline |
| 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. | 12 months from baseline |
| Stair Climbing Time | measured in seconds using the participant's fastest time achieved to climb a 12 step staircase in two trials. | 12 months from baseline |
| 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) | 12 months from baseline |
| 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 | 12 months from baseline |
| 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. | 12 months from baseline |
| 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. | 12 months from baseline |
| 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. | 12 months from baseline |
| 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. | 12 months from baseline |
| 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. | 6 months from baseline |
| Overall Satisfaction Participating in the Optional Insole Visits | overall satisfaction measured by a scale from 1-5 with a higher score indicating greater satisfaction | 6 months from baseline |
| 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. |
| 33631359 | 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. |
| Relocated out of state |
|
| COVID concerns |
|
| Adverse Event |
|
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) |
| BG002 | 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) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (kg/m2) | Mean | Standard Deviation | Kilograms |
|
| Height | Mean | Standard Deviation | Centimeters |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Education | Count of Participants | Participants |
|
| Comorbidities | Count of Participants | Participants |
|
| Low Bone Mass | Count of Participants | Participants |
|
| Total Physical Activity | Median | Inter-Quartile Range | Kilocalories Per Week |
|
| Fast Gait Speed | 3 participants in the Weight Loss Plus Vest arm did not complete this task at baseline. 2 participants in the Resistance Exercise Training arm did not complete this task at baseline. | Mean | Standard Deviation | Meters Per Second |
|
| Moderate Intensity Physical Activity | Median | Inter-Quartile Range | Minutes Per Week |
|
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) |
| OG002 | 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) |
|
|
| Secondary | Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD) | measured in mg/cm3 during computed tomography (CT) scan | 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. | Posted | Mean | 95% Confidence Interval | mg/cm3 | 6 months from baseline |
|
|
|
| Secondary | Change in Femoral Neck Volumetric Bone Mineral Density (vBMD) | measured in mg/cm3 during computed tomography (CT) scan | 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. | Posted | Mean | 95% Confidence Interval | mg/cm3 | 6 months from baseline |
|
|
|
| Secondary | Change in Femoral Neck Volumetric Bone Mineral Density (vBMD) | measured in mg/cm3 during computed tomography (CT) scan | 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. | Posted | Mean | 95% Confidence Interval | mg/cm3 | 12 months from baseline |
|
|
|
| Secondary | Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD) | measured in mg/cm3 during computed tomography (CT) scan | 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. | Posted | Mean | 95% Confidence Interval | mg/cm3 | 6 months from baseline |
|
|
|
| Secondary | Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD) | measured in mg/cm3 during computed tomography (CT) scan | 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. | Posted | Mean | 95% Confidence Interval | mg/cm3 | 12 months from baseline |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months from baseline |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months from baseline |
|
|
|
| Secondary | Change in Total Hip Areal Bone Mineral Density (aBMD) | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan | 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. | Posted | Mean | 95% Confidence Interval | g/cm2 | 6 months from baseline |
|
|
|
| Secondary | Change in Total Hip Areal Bone Mineral Density (aBMD) | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan | 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. | Posted | Mean | 95% Confidence Interval | g/cm2 | 12 months from baseline |
|
|
|
| Secondary | Change in Femoral Neck Areal Bone Mineral Density (aBMD) | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan | 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. | Posted | Mean | 95% Confidence Interval | g/cm2 | 6 months from baseline |
|
|
|
| Secondary | Change in Femoral Neck Areal Bone Mineral Density (aBMD) | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan | 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. | Posted | Mean | 95% Confidence Interval | g/cm2 | 12 months from baseline |
|
|
|
| Secondary | Change in Distal Radius Areal Bone Mineral Density (aBMD) | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan | 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. | Posted | Mean | 95% Confidence Interval | g/cm2 | 6 months from baseline |
|
|
|
| Secondary | Change in Distal Radius Areal Bone Mineral Density (aBMD) | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan | 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. | Posted | Mean | 95% Confidence Interval | g/cm2 | 12 months from baseline |
|
|
|
| Secondary | Change in Lumbar Spine Areal Bone Mineral Density (aBMD) | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan | 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. | Posted | Mean | 95% Confidence Interval | g/cm2 | 6 months from baseline |
|
|
|
| Secondary | Change in Lumbar Spine Areal Bone Mineral Density (aBMD) | measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan | 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. | Posted | Mean | 95% Confidence Interval | g/cm2 | 12 months from baseline |
|
|
|
| Secondary | Change in Total Body Fat Mass (kg) | measurement taken during dual energy x-ray absorptiometry (DXA) scan | 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. | Posted | Mean | 95% Confidence Interval | kg | 6 months from baseline |
|
|
|
| Secondary | Change in Total Body Fat Mass (kg) | measurement taken during dual energy x-ray absorptiometry (DXA) scan | 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. | Posted | Mean | 95% Confidence Interval | kg | 12 months from baseline |
|
|
|
| Secondary | Change in Total Body Lean Mass (kg) | measurement taken during dual energy x-ray absorptiometry (DXA) | 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. | Posted | Mean | 95% Confidence Interval | kg | 6 months from baseline |
|
|
|
| Secondary | Change in Total Body Lean Mass (kg) | measurement taken during dual energy x-ray absorptiometry (DXA) | 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. | Posted | Mean | 95% Confidence Interval | kg | 12 months from baseline |
|
|
|
| Other Pre-specified | Mid-thigh Muscle Density Measured in Hounsfield Units (HU) | measurement taken during computed tomography (CT) scan | Not Posted | 12 months from baseline | Participants |
| Other Pre-specified | Mid- Thigh Intermuscular Fat Cross Sectional Area (CSA) (cm2) | measurement taken during computed tomography (CT) scan | Not Posted | 12 months from baseline | Participants |
| Other Pre-specified | Cortical Thickness (mm) | measurement taken during computed tomography (CT) scan | Not Posted | 12 months from baseline | Participants |
| Other Pre-specified | Finite Element (FE) Modeling of Bone Strength Measured in Kilonewton (kN) | measurement taken during computed tomography (CT) scan | Not Posted | 12 months from baseline | Participants |
| Other Pre-specified | Mid-thigh Muscle CSA (cm2) | measurement taken during computed tomography (CT) scan | Not Posted | 12 months from baseline | Participants |
| Other Pre-specified | L3 Muscle Density Measured in HU | measurement taken during computed tomography (CT) scan | Not Posted | 12 months from baseline | Participants |
| Other Pre-specified | L3 Intermuscular Fat CSA (cm2) | measurement taken during computed tomography (CT) scan | Not Posted | 12 months from baseline | Participants |
| Other Pre-specified | L3 Muscle CSA (cm2) | measurement taken during computed tomography (CT) scan | Not Posted | 12 months from baseline | Participants |
| Other Pre-specified | Concentration of Procollagen 1 Intact N-Terminal Propeptide (P1NP) (ug/L) | Biomarkers of bone turnover measured via blood specimen | Not Posted | 12 months from baseline | Participants |
| Other Pre-specified | Concentration of C-terminal Telopeptide (CTX) (pg/mL) | Biomarkers of bone turnover measured via blood specimen | Not Posted | 12 months from baseline | Participants |
| Other Pre-specified | D3-Creatine Derived Muscle Mass Measured in kg | measurement taken via urine sample | Not Posted | 12 months from baseline | Participants |
| Other Pre-specified | Gait Speed | measured in m/s during the 400 meter walk test | Not Posted | 12 months from baseline | Participants |
| 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. | Not Posted | 12 months from baseline | Participants |
| 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. | Not Posted | 12 months from baseline | Participants |
| 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. | Not Posted | 12 months from baseline | Participants |
| 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) | Not Posted | 12 months from baseline | Participants |
| 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 | Not Posted | 12 months from baseline | Participants |
| 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. | Not Posted | 12 months from baseline | Participants |
| 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. | Not Posted | 12 months from baseline | Participants |
| 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. | Not Posted | 12 months from baseline | Participants |
| 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. | Not Posted | 12 months from baseline | Participants |
| 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. | Not Posted | 6 months from baseline | Participants |
| 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 | Not Posted | 6 months from baseline | Participants |
| 0 |
| 50 |
| 3 |
| 50 |
| 23 |
| 50 |
| EG001 | 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) | 0 | 50 | 1 | 50 | 22 | 50 |
| EG002 | 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) | 0 | 50 | 2 | 50 | 20 | 50 |
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Motor vehicle accident | Social circumstances | Systematic Assessment |
|
| Prostate transurethral resection | Renal and urinary disorders | Systematic Assessment |
|
| Retinal detachment | Eye disorders | Systematic Assessment |
|
| COVID-19 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006293 | Health Promotion |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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