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| Name | Class |
|---|---|
| Medifast, Inc. | INDUSTRY |
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The purpose of this research study is to see whether wearing a weighted vest during a period of active weight loss can decrease the loss of muscle and bone that occurs during weight loss. We will also determine if study participants who wear the weighted vest will have greater improvements in physical function and self-reported disability, pain, stiffness, fatigue and quality of life. This knowledge could impact weight loss programs designed for older adults.
Hypothesis: Participants randomized to VEST will experience similar weight loss, but less loss of lean mass and bone density, than participants randomized to Control.
The loss of muscle mass and bone density during weight loss is partially attributed to the decrease in mechanical stress on these tissues as weight is reduced. As a result, performing exercises that enhance muscle and gravitational loading during the period of caloric restriction usually diminishes the relative amount of muscle and bone loss for a given weight loss, but these interventions do not fully prevent all muscle and bone loss.In addition, conventional exercise training interventions often require expensive equipment, on-site participation, and, ideally for older, obese adults, safety supervision by trained exercise leaders. Moreover, the exercises performed may not fully translate into improvement in daily tasks due to training specificity, and are not always tolerated or sustained, especially in obese persons with OA. On the other hand, it is conceivable that treating the decrease in mechanical load from weight loss by externally replacing lost weight via use of a weighted vest may also be effective for reducing muscle and bone loss during caloric restriction. In animal models, mechanisms regulating skeletal tissue structure and function respond in a similar fashion to increases in actual or externally-added body mass. Also, research shows that exercising while wearing weighted vests can improve bone density, muscle mass, and lower extremity strength in older adults. However, no prior studies have examined the effects of weighted vest use on muscle mass and bone density during a period of intentional weight loss.
The main objective of this pilot study is to assess feasibility (accrual, retention, compliance) of daily use of a weighted vest during a diet intervention, to estimate the variability of outcome measures, and to obtain preliminary estimates of treatment efficacy. A controlled, randomized design will be used so we can obtain a realistic estimate of accrual and an unbiased estimate of treatment efficacy.
A total of 36 older (age=65-79 yrs), obese (BMI=30-40 kg/m2), sedentary men and women with x-ray evidence of knee OA will undergo a 22 week weight loss intervention (targeting 10% weight loss) with randomization to one of two groups (n=18/grp): 1) No vest use (Control); or 2) Progressive weighted vest use during normal daily activities (VEST).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vest + Diet | Experimental | 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. |
|
| No Vest + Diet | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vest | Behavioral | light weight, adjustable, vest to be worn underneath clothes that weight can be added to |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lean Mass Measured by DXA | Lean body mass (Whole body and lower-extremity lean mass are used in total calculation). | Baseline and 22 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hip Bone Density | Hip bone density as measured by DXA. | Basleine and 22 weeks |
| Changes in Self-report on Fatigue Using Pittsburgh Fatigability Scale (PFS) | Pittsburgh 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Body weight | Baseline and 22 weeks |
| Changes in Lower Extremity Physical Function | SPPB 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara J. Nicklas, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health Sticht Center on Aging | Winston-Salem | North Carolina | 27157 | United States |
All data will be made available upon email request to the study PI and upon completion of a data-sharing agreement. This agreement will require that data be used only for research purposes, that no attempts be made to identify individual patients, that the data will be kept secure, that the user will not distribute the data to other researchers, that the user will return the files or destroy them once the project is completed, and that the user will acknowledge the data source. All data files will be de-identified. In addition, variables that could permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects will be removed or recoded. We will create a link on our website that describes our study and the data available for data sharing with descriptions.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 Lean Mass Measured by DXA | Lean body mass (Whole body and lower-extremity lean mass are used in total calculation). | Posted | Mean | Standard Deviation | Kg | Baseline and 22 weeks |
|
26 weeks
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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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diverticulitis | Gastrointestinal disorders | Systematic Assessment | participant had history of diverticulitis since 1980s until 11/2013 which was cleared by antibiotics. With this episode, participant when to doctor as soon as symptoms started. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| back spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara Nicklas | WFSM | 3367138569 | bnicklas@wakehealth.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D010003 | Osteoarthritis |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Diet | Behavioral | 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. |
|
|
| baseline and 22 weeks |
| Baseline and 22 weeks |
| Lost to Follow-up |
|
| BG001 | 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. |
| BG002 | 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 |
|
| Region of Enrollment | Number | participants |
|
| OG001 | No Vest+Diet | 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. |
|
|
| Secondary | Change in Hip Bone Density | Hip bone density as measured by DXA. | Posted | Mean | 95% Confidence Interval | g/cm2 | Basleine and 22 weeks |
|
|
|
| Secondary | Changes in Self-report on Fatigue Using Pittsburgh Fatigability Scale (PFS) | Pittsburgh 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and 22 weeks |
|
|
|
| Other Pre-specified | Change in Body Weight | Body weight | Posted | Mean | Standard Deviation | kg | Baseline and 22 weeks |
|
|
|
| Other Pre-specified | Changes in Lower Extremity Physical Function | SPPB 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 22 weeks |
|
|
|
| 0 |
| 20 |
| 2 |
| 20 |
| 15 |
| 20 |
| EG001 | 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. | 0 | 17 | 2 | 17 | 10 | 17 |
|
| dehydration | Metabolism and nutrition disorders | Systematic Assessment | Participant became dehydrated after another illness. participant felt it was due to medications- sudafed and mucinex. Participant was hospitalized overnight. |
|
| bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Was seen in the Emergency room for bronchitis |
|
| chest pain | Cardiac disorders | Systematic Assessment | participant had chest pain. Went to hospital and ended up having a blockage that required a stent |
|
| pulled back muscle/ back pain/ neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| bronchitis/pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| diarrhea/nausea/stomach virus | Gastrointestinal disorders | Systematic Assessment |
|
| Tripped and fell | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| sinus infection/cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| compression fracture in spine | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| twisted knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| injured by fallen debri | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| fracture in ankle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| dizzy while standing | Ear and labyrinth disorders | Systematic Assessment |
|
| lesion removed from under eye | Eye disorders | Systematic Assessment |
|
| vericous vein swelling | Vascular disorders | Systematic Assessment |
|
| tingling/numbness in back/arm | Nervous system disorders | Systematic Assessment |
|
| drug reaction to sulfamethaxayole | Injury, poisoning and procedural complications | Systematic Assessment |
|
| urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| pulled muscle in shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| oxygen level drops at night | General disorders | Systematic Assessment |
|
| lower lip swelling | Injury, poisoning and procedural complications | Systematic Assessment |
|
| gout flare up | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| spinal column pressing on nerves | Nervous system disorders | Systematic Assessment |
|
| pinch in back | Nervous system disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001836 | Body Weight Changes |