Trial Outcomes & Findings for Incorporating Nutrition, Vests, Education, and Strength Training in Bone Health (INVEST in Bone Health) (NCT NCT04076618)
NCT ID: NCT04076618
Last Updated: 2025-02-06
Results Overview
measured in mg/cm3 during computed tomography (CT) scan
COMPLETED
NA
150 participants
12 months from baseline
2025-02-06
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
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)
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
45
|
45
|
43
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
7
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
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)
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
2
|
|
Overall Study
Relocated out of state
|
0
|
2
|
0
|
|
Overall Study
COVID concerns
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Weight Loss Plus Vest
n=50 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=50 Participants
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)
|
Weight Loss
n=50 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 4.5 • n=50 Participants
|
66.4 years
STANDARD_DEVIATION 5.1 • n=50 Participants
|
65.9 years
STANDARD_DEVIATION 4.2 • n=50 Participants
|
66.4 years
STANDARD_DEVIATION 4.6 • n=150 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=50 Participants
|
38 Participants
n=50 Participants
|
37 Participants
n=50 Participants
|
112 Participants
n=150 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=50 Participants
|
12 Participants
n=50 Participants
|
13 Participants
n=50 Participants
|
38 Participants
n=150 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
3 Participants
n=150 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=50 Participants
|
49 Participants
n=50 Participants
|
49 Participants
n=50 Participants
|
147 Participants
n=150 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=150 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=150 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=150 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=150 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=50 Participants
|
15 Participants
n=50 Participants
|
12 Participants
n=50 Participants
|
43 Participants
n=150 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=50 Participants
|
35 Participants
n=50 Participants
|
35 Participants
n=50 Participants
|
103 Participants
n=150 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
4 Participants
n=150 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=150 Participants
|
|
Body Mass Index (kg/m2)
|
93.6 Kilograms
STANDARD_DEVIATION 12.3 • n=50 Participants
|
92.7 Kilograms
STANDARD_DEVIATION 11.9 • n=50 Participants
|
92.3 Kilograms
STANDARD_DEVIATION 14.3 • n=50 Participants
|
92.9 Kilograms
STANDARD_DEVIATION 12.8 • n=150 Participants
|
|
Height
|
166.5 Centimeters
STANDARD_DEVIATION 8.5 • n=50 Participants
|
166.0 Centimeters
STANDARD_DEVIATION 8.0 • n=50 Participants
|
166.0 Centimeters
STANDARD_DEVIATION 8.8 • n=50 Participants
|
166.2 Centimeters
STANDARD_DEVIATION 8.4 • n=150 Participants
|
|
Body Mass Index
|
33.8 kg/m2
STANDARD_DEVIATION 3.7 • n=50 Participants
|
33.6 kg/m2
STANDARD_DEVIATION 3.0 • n=50 Participants
|
33.4 kg/m2
STANDARD_DEVIATION 3.3 • n=50 Participants
|
33.6 kg/m2
STANDARD_DEVIATION 3.3 • n=150 Participants
|
|
Education
High School Equivalent
|
13 Participants
n=50 Participants
|
7 Participants
n=50 Participants
|
8 Participants
n=50 Participants
|
28 Participants
n=150 Participants
|
|
Education
College
|
23 Participants
n=50 Participants
|
27 Participants
n=50 Participants
|
31 Participants
n=50 Participants
|
81 Participants
n=150 Participants
|
|
Education
Post Graduate
|
14 Participants
n=50 Participants
|
16 Participants
n=50 Participants
|
11 Participants
n=50 Participants
|
41 Participants
n=150 Participants
|
|
Comorbidities
Diabetes
|
5 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
6 Participants
n=50 Participants
|
12 Participants
n=150 Participants
|
|
Comorbidities
Cardiovascular Disease
|
4 Participants
n=50 Participants
|
6 Participants
n=50 Participants
|
6 Participants
n=50 Participants
|
16 Participants
n=150 Participants
|
|
Comorbidities
Arthritis/Joint Pain
|
39 Participants
n=50 Participants
|
29 Participants
n=50 Participants
|
36 Participants
n=50 Participants
|
104 Participants
n=150 Participants
|
|
Low Bone Mass
|
24 Participants
n=50 Participants
|
23 Participants
n=50 Participants
|
26 Participants
n=50 Participants
|
73 Participants
n=150 Participants
|
|
Total Physical Activity
|
1941 Kilocalories Per Week
n=50 Participants
|
2144 Kilocalories Per Week
n=50 Participants
|
2042 Kilocalories Per Week
n=50 Participants
|
2029 Kilocalories Per Week
n=150 Participants
|
|
Fast Gait Speed
|
1.3 Meters Per Second
STANDARD_DEVIATION 0.2 • n=47 Participants • 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.
|
1.3 Meters Per Second
STANDARD_DEVIATION 0.2 • n=48 Participants • 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.
|
1.3 Meters Per Second
STANDARD_DEVIATION 0.1 • n=50 Participants • 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.
|
1.3 Meters Per Second
STANDARD_DEVIATION 0.2 • n=145 Participants • 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.
|
|
Moderate Intensity Physical Activity
|
30 Minutes Per Week
n=50 Participants
|
45 Minutes Per Week
n=50 Participants
|
0 Minutes Per Week
n=50 Participants
|
30 Minutes Per Week
n=150 Participants
|
PRIMARY outcome
Timeframe: 12 months from baselinePopulation: 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.
measured in mg/cm3 during computed tomography (CT) scan
Outcome measures
| Measure |
Weight Loss Plus Vest
n=44 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=45 Participants
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)
|
Weight Loss
n=43 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD)
|
-0.002 mg/cm3
Interval -0.003 to -0.001
|
-0.002 mg/cm3
Interval -0.003 to -0.001
|
-0.003 mg/cm3
Interval -0.003 to -0.002
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: 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.
measured in mg/cm3 during computed tomography (CT) scan
Outcome measures
| Measure |
Weight Loss Plus Vest
n=46 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=46 Participants
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)
|
Weight Loss
n=44 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD)
|
-0.001 mg/cm3
Interval -0.001 to 0.0
|
-0.000 mg/cm3
Interval -0.001 to 0.001
|
-0.000 mg/cm3
Interval -0.001 to 0.0
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: 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.
measured in mg/cm3 during computed tomography (CT) scan
Outcome measures
| Measure |
Weight Loss Plus Vest
n=46 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=46 Participants
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)
|
Weight Loss
n=44 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Femoral Neck Volumetric Bone Mineral Density (vBMD)
|
-0.001 mg/cm3
Interval -0.003 to 0.001
|
-0.001 mg/cm3
Interval -0.003 to 0.001
|
-0.001 mg/cm3
Interval -0.002 to 0.001
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: 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.
measured in mg/cm3 during computed tomography (CT) scan
Outcome measures
| Measure |
Weight Loss Plus Vest
n=44 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=45 Participants
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)
|
Weight Loss
n=43 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Femoral Neck Volumetric Bone Mineral Density (vBMD)
|
-0.002 mg/cm3
Interval -0.004 to 0.001
|
-0.003 mg/cm3
Interval -0.005 to 0.0
|
-0.004 mg/cm3
Interval -0.007 to -0.002
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: 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.
measured in mg/cm3 during computed tomography (CT) scan
Outcome measures
| Measure |
Weight Loss Plus Vest
n=47 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=46 Participants
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)
|
Weight Loss
n=45 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD)
|
0.001 mg/cm3
Interval -0.002 to 0.005
|
0.005 mg/cm3
Interval 0.001 to 0.008
|
0.005 mg/cm3
Interval 0.002 to 0.008
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: 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.
measured in mg/cm3 during computed tomography (CT) scan
Outcome measures
| Measure |
Weight Loss Plus Vest
n=45 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=45 Participants
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)
|
Weight Loss
n=43 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD)
|
-0.000 mg/cm3
Interval -0.002 to 0.002
|
0.003 mg/cm3
Interval 0.001 to 0.005
|
0.000 mg/cm3
Interval -0.002 to 0.002
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: 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.
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.
Outcome measures
| Measure |
Weight Loss Plus Vest
n=47 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=47 Participants
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)
|
Weight Loss
n=45 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Trabecular Bone Score (TBS)
|
0.020 score on a scale
Interval 0.002 to 0.039
|
0.037 score on a scale
Interval 0.018 to 0.056
|
0.017 score on a scale
Interval -0.002 to 0.035
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: 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.
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.
Outcome measures
| Measure |
Weight Loss Plus Vest
n=45 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=45 Participants
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)
|
Weight Loss
n=43 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Trabecular Bone Score (TBS)
|
0.014 score on a scale
Interval -0.005 to 0.034
|
0.037 score on a scale
Interval 0.017 to 0.057
|
0.017 score on a scale
Interval -0.003 to 0.037
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: 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.
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Outcome measures
| Measure |
Weight Loss Plus Vest
n=47 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=47 Participants
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)
|
Weight Loss
n=45 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Total Hip Areal Bone Mineral Density (aBMD)
|
-0.006 g/cm2
Interval -0.013 to 0.001
|
-0.008 g/cm2
Interval -0.015 to -0.001
|
-0.008 g/cm2
Interval -0.015 to -0.001
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: 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.
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Outcome measures
| Measure |
Weight Loss Plus Vest
n=45 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=45 Participants
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)
|
Weight Loss
n=43 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Total Hip Areal Bone Mineral Density (aBMD)
|
-0.015 g/cm2
Interval -0.023 to -0.007
|
-0.016 g/cm2
Interval -0.024 to -0.008
|
-0.017 g/cm2
Interval -0.025 to -0.009
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: 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.
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Outcome measures
| Measure |
Weight Loss Plus Vest
n=47 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=47 Participants
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)
|
Weight Loss
n=45 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Femoral Neck Areal Bone Mineral Density (aBMD)
|
-0.000 g/cm2
Interval -0.011 to 0.01
|
0.004 g/cm2
Interval -0.007 to 0.014
|
0.004 g/cm2
Interval -0.007 to 0.015
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: 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.
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Outcome measures
| Measure |
Weight Loss Plus Vest
n=45 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=45 Participants
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)
|
Weight Loss
n=43 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Femoral Neck Areal Bone Mineral Density (aBMD)
|
-0.006 g/cm2
Interval -0.017 to 0.005
|
-0.004 g/cm2
Interval -0.015 to 0.008
|
-0.005 g/cm2
Interval -0.016 to 0.007
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: 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.
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Outcome measures
| Measure |
Weight Loss Plus Vest
n=47 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=47 Participants
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)
|
Weight Loss
n=45 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Distal Radius Areal Bone Mineral Density (aBMD)
|
-0.009 g/cm2
Interval -0.018 to 0.0
|
-0.008 g/cm2
Interval -0.018 to 0.001
|
-0.007 g/cm2
Interval -0.016 to 0.002
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: 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.
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Outcome measures
| Measure |
Weight Loss Plus Vest
n=45 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=45 Participants
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)
|
Weight Loss
n=43 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Distal Radius Areal Bone Mineral Density (aBMD)
|
-0.013 g/cm2
Interval -0.022 to -0.003
|
-0.007 g/cm2
Interval -0.017 to 0.003
|
-0.013 g/cm2
Interval -0.022 to -0.003
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: 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.
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Outcome measures
| Measure |
Weight Loss Plus Vest
n=47 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=47 Participants
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)
|
Weight Loss
n=45 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Lumbar Spine Areal Bone Mineral Density (aBMD)
|
0.003 g/cm2
Interval -0.011 to 0.017
|
0.015 g/cm2
Interval 0.0 to 0.03
|
0.016 g/cm2
Interval 0.001 to 0.03
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: 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.
measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan
Outcome measures
| Measure |
Weight Loss Plus Vest
n=45 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=45 Participants
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)
|
Weight Loss
n=43 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Lumbar Spine Areal Bone Mineral Density (aBMD)
|
0.006 g/cm2
Interval -0.012 to 0.023
|
0.011 g/cm2
Interval -0.007 to 0.028
|
0.010 g/cm2
Interval -0.008 to 0.027
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: 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.
measurement taken during dual energy x-ray absorptiometry (DXA) scan
Outcome measures
| Measure |
Weight Loss Plus Vest
n=47 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=47 Participants
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)
|
Weight Loss
n=45 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Total Body Fat Mass (kg)
|
-7.8 kg
Interval -9.1 to -6.5
|
-8.8 kg
Interval -10.2 to -7.5
|
-7.8 kg
Interval -9.2 to -6.5
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: 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.
measurement taken during dual energy x-ray absorptiometry (DXA) scan
Outcome measures
| Measure |
Weight Loss Plus Vest
n=45 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=45 Participants
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)
|
Weight Loss
n=43 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Total Body Fat Mass (kg)
|
-7.3 kg
Interval -8.9 to -5.7
|
-10.0 kg
Interval -11.6 to -8.3
|
-7.7 kg
Interval -9.4 to -6.0
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: 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.
measurement taken during dual energy x-ray absorptiometry (DXA)
Outcome measures
| Measure |
Weight Loss Plus Vest
n=47 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=47 Participants
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)
|
Weight Loss
n=45 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Total Body Lean Mass (kg)
|
-0.5 kg
Interval -1.1 to 0.0
|
-0.8 kg
Interval -1.4 to -0.2
|
-0.7 kg
Interval -1.2 to -0.1
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: 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.
measurement taken during dual energy x-ray absorptiometry (DXA)
Outcome measures
| Measure |
Weight Loss Plus Vest
n=45 Participants
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)
|
Weight Loss Plus Resistance Exercise Training
n=45 Participants
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)
|
Weight Loss
n=43 Participants
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Change in Total Body Lean Mass (kg)
|
-0.7 kg
Interval -1.3 to -0.2
|
-0.9 kg
Interval -1.4 to -0.3
|
-0.9 kg
Interval -1.5 to -0.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasurement taken during computed tomography (CT) scan
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasurement taken during computed tomography (CT) scan
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasurement taken during computed tomography (CT) scan
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasurement taken during computed tomography (CT) scan
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasurement taken during computed tomography (CT) scan
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasurement taken during computed tomography (CT) scan
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasurement taken during computed tomography (CT) scan
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasurement taken during computed tomography (CT) scan
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselineBiomarkers of bone turnover measured via blood specimen
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselineBiomarkers of bone turnover measured via blood specimen
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasurement taken via urine sample
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasured in m/s during the 400 meter walk test
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselineThe 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasured 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasured in seconds using the participant's fastest time achieved to climb a 12 step staircase in two trials.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasured 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)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasured 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasured using the Montreal Cognitive Assessment (MOCA) with scores ranging from 0-30, with a score of 26 and higher generally considered normal.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasured 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselinemeasured 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from baselineThe 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months from baselinemeasured 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months from baselineoverall satisfaction measured by a scale from 1-5 with a higher score indicating greater satisfaction
Outcome measures
Outcome data not reported
Adverse Events
Weight Loss Plus Vest
Weight Loss Plus Resistance Exercise Training
Weight Loss
Serious adverse events
| Measure |
Weight Loss Plus Vest
n=50 participants at risk
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)
|
Weight Loss Plus Resistance Exercise Training
n=50 participants at risk
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)
|
Weight Loss
n=50 participants at risk
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Renal and urinary disorders
Prostate transurethral resection
|
0.00%
0/50 • Baseline through Month 12
|
0.00%
0/50 • Baseline through Month 12
|
2.0%
1/50 • Number of events 1 • Baseline through Month 12
|
|
Eye disorders
Retinal detachment
|
2.0%
1/50 • Number of events 1 • Baseline through Month 12
|
0.00%
0/50 • Baseline through Month 12
|
0.00%
0/50 • Baseline through Month 12
|
|
Gastrointestinal disorders
Small bowel obstruction
|
2.0%
1/50 • Number of events 1 • Baseline through Month 12
|
0.00%
0/50 • Baseline through Month 12
|
2.0%
1/50 • Number of events 1 • Baseline through Month 12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/50 • Baseline through Month 12
|
2.0%
1/50 • Number of events 1 • Baseline through Month 12
|
0.00%
0/50 • Baseline through Month 12
|
|
Social circumstances
Motor vehicle accident
|
2.0%
1/50 • Number of events 1 • Baseline through Month 12
|
0.00%
0/50 • Baseline through Month 12
|
0.00%
0/50 • Baseline through Month 12
|
Other adverse events
| Measure |
Weight Loss Plus Vest
n=50 participants at risk
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)
|
Weight Loss Plus Resistance Exercise Training
n=50 participants at risk
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)
|
Weight Loss
n=50 participants at risk
weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
|
|---|---|---|---|
|
Social circumstances
Fall
|
24.0%
12/50 • Number of events 14 • Baseline through Month 12
|
12.0%
6/50 • Number of events 7 • Baseline through Month 12
|
20.0%
10/50 • Number of events 10 • Baseline through Month 12
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
10.0%
5/50 • Number of events 5 • Baseline through Month 12
|
20.0%
10/50 • Number of events 11 • Baseline through Month 12
|
10.0%
5/50 • Number of events 5 • Baseline through Month 12
|
|
Infections and infestations
Sinusitis
|
4.0%
2/50 • Number of events 2 • Baseline through Month 12
|
4.0%
2/50 • Number of events 2 • Baseline through Month 12
|
12.0%
6/50 • Number of events 7 • Baseline through Month 12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
6/50 • Number of events 6 • Baseline through Month 12
|
6.0%
3/50 • Number of events 3 • Baseline through Month 12
|
2.0%
1/50 • Number of events 1 • Baseline through Month 12
|
|
Renal and urinary disorders
Urinary tract infection
|
4.0%
2/50 • Number of events 2 • Baseline through Month 12
|
6.0%
3/50 • Number of events 4 • Baseline through Month 12
|
2.0%
1/50 • Number of events 1 • Baseline through Month 12
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
6.0%
3/50 • Number of events 3 • Baseline through Month 12
|
4.0%
2/50 • Number of events 2 • Baseline through Month 12
|
2.0%
1/50 • Number of events 1 • Baseline through Month 12
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
2.0%
1/50 • Number of events 1 • Baseline through Month 12
|
6.0%
3/50 • Number of events 3 • Baseline through Month 12
|
0.00%
0/50 • Baseline through Month 12
|
Additional Information
Kristen Beavers, PhD, MPH, RD
Wake Forest University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place