Trial Outcomes & Findings for Arthritis Pilot for Preserving Muscle While Losing Weight (NCT NCT02239939)
NCT ID: NCT02239939
Last Updated: 2018-03-09
Results Overview
Lean body mass (Whole body and lower-extremity lean mass are used in total calculation).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
Baseline and 22 weeks
Results posted on
2018-03-09
Participant Flow
Participant milestones
| Measure |
Vest + Diet
All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for \>10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
No Vest + Diet
All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
|
Overall Study
COMPLETED
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Vest + Diet
All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for \>10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
No Vest + Diet
All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Arthritis Pilot for Preserving Muscle While Losing Weight
Baseline characteristics by cohort
| Measure |
Vest + Diet
n=20 Participants
All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for \>10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
No Vest + Diet
n=17 Participants
All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.3 years
STANDARD_DEVIATION 3.4 • n=93 Participants
|
69.9 years
STANDARD_DEVIATION 2.6 • n=4 Participants
|
70.1 years
STANDARD_DEVIATION 3.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
17 participants
n=4 Participants
|
37 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 22 weeksLean body mass (Whole body and lower-extremity lean mass are used in total calculation).
Outcome measures
| Measure |
Diet+Vest
n=18 Participants
All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for \>10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
No Vest+Diet
n=15 Participants
All participants will undergo a 22 week dietary weight loss.
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
|---|---|---|
|
Change in Lean Mass Measured by DXA
|
-2.9 Kg
Standard Deviation 1.6
|
-2.3 Kg
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Basleine and 22 weeksHip bone density as measured by DXA.
Outcome measures
| Measure |
Diet+Vest
n=18 Participants
All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for \>10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
No Vest+Diet
n=15 Participants
All participants will undergo a 22 week dietary weight loss.
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
|---|---|---|
|
Change in Hip Bone Density
|
-6.1 g/cm2
Interval -15.7 to 3.5
|
-18.7 g/cm2
Interval -29.3 to -8.1
|
SECONDARY outcome
Timeframe: baseline and 22 weeksPittsburgh Fatigability Scale (PFS) is a self-administered 10 item assessment. It asks participants to rate the level of physical and mental fatigue they experience or imagine after completing a set of hypothetical activities related to daily life at a fixed intensity and duration. The participant provides a score from 0-5 where "0' equals no fatigue at all, and "5" equals extreme fatigue.
Outcome measures
| Measure |
Diet+Vest
n=18 Participants
All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for \>10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
No Vest+Diet
n=15 Participants
All participants will undergo a 22 week dietary weight loss.
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
|---|---|---|
|
Changes in Self-report on Fatigue Using Pittsburgh Fatigability Scale (PFS)
|
15.3 units on a scale
Standard Deviation 13.6
|
12.3 units on a scale
Standard Deviation 14.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 22 weeksBody weight
Outcome measures
| Measure |
Diet+Vest
n=18 Participants
All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for \>10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
No Vest+Diet
n=15 Participants
All participants will undergo a 22 week dietary weight loss.
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
|---|---|---|
|
Change in Body Weight
|
-110.6 kg
Standard Deviation 5.7
|
-10.9 kg
Standard Deviation 4.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 22 weeksSPPB is a measure of lower-extremity function consisting of walking speed, balance, and repeated chair stands. These 3 performance measures are scored from 0 to 4, with 4 indicating the highest level of performance and 0 the inability to complete the task, with a summary score of 0-12.The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.
Outcome measures
| Measure |
Diet+Vest
n=18 Participants
All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for \>10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
No Vest+Diet
n=15 Participants
All participants will undergo a 22 week dietary weight loss.
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
|---|---|---|
|
Changes in Lower Extremity Physical Function
|
0.1 units on a scale
Standard Deviation 0.34
|
0.15 units on a scale
Standard Deviation 0.16
|
Adverse Events
Vest + Diet
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
No Vest + Diet
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vest + Diet
n=20 participants at risk
All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for \>10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
No Vest + Diet
n=17 participants at risk
All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
|---|---|---|
|
Gastrointestinal disorders
diverticulitis
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
0.00%
0/17 • 26 weeks
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/20 • 26 weeks
|
5.9%
1/17 • Number of events 1 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
0.00%
0/20 • 26 weeks
|
5.9%
1/17 • Number of events 1 • 26 weeks
|
|
Cardiac disorders
chest pain
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
0.00%
0/17 • 26 weeks
|
Other adverse events
| Measure |
Vest + Diet
n=20 participants at risk
All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for \>10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
No Vest + Diet
n=17 participants at risk
All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
back spasms
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
0.00%
0/17 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
pulled back muscle/ back pain/ neck pain
|
30.0%
6/20 • Number of events 6 • 26 weeks
|
5.9%
1/17 • Number of events 1 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis/pneumonia
|
20.0%
4/20 • Number of events 4 • 26 weeks
|
0.00%
0/17 • 26 weeks
|
|
Gastrointestinal disorders
diarrhea/nausea/stomach virus
|
15.0%
3/20 • Number of events 3 • 26 weeks
|
0.00%
0/17 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Tripped and fell
|
10.0%
2/20 • Number of events 2 • 26 weeks
|
0.00%
0/17 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
sinus infection/cold
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
11.8%
2/17 • Number of events 2 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
compression fracture in spine
|
0.00%
0/20 • 26 weeks
|
5.9%
1/17 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
twisted knee
|
0.00%
0/20 • 26 weeks
|
5.9%
1/17 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
injured by fallen debri
|
0.00%
0/20 • 26 weeks
|
5.9%
1/17 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
fracture in ankle
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
0.00%
0/17 • 26 weeks
|
|
Ear and labyrinth disorders
dizzy while standing
|
0.00%
0/20 • 26 weeks
|
5.9%
1/17 • Number of events 1 • 26 weeks
|
|
Eye disorders
lesion removed from under eye
|
0.00%
0/20 • 26 weeks
|
5.9%
1/17 • Number of events 1 • 26 weeks
|
|
Vascular disorders
vericous vein swelling
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
0.00%
0/17 • 26 weeks
|
|
Nervous system disorders
tingling/numbness in back/arm
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
0.00%
0/17 • 26 weeks
|
|
Injury, poisoning and procedural complications
drug reaction to sulfamethaxayole
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
0.00%
0/17 • 26 weeks
|
|
Renal and urinary disorders
urinary tract infection
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
0.00%
0/17 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
knee pain
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
0.00%
0/17 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
pulled muscle in shoulder
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
0.00%
0/17 • 26 weeks
|
|
General disorders
oxygen level drops at night
|
0.00%
0/20 • 26 weeks
|
5.9%
1/17 • Number of events 1 • 26 weeks
|
|
Injury, poisoning and procedural complications
lower lip swelling
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
0.00%
0/17 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
gout flare up
|
0.00%
0/20 • 26 weeks
|
5.9%
1/17 • Number of events 1 • 26 weeks
|
|
Nervous system disorders
spinal column pressing on nerves
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
0.00%
0/17 • 26 weeks
|
|
Nervous system disorders
pinch in back
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
0.00%
0/17 • 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place