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| Name | Class |
|---|---|
| Paralyzed Veterans of America | OTHER |
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The goals of the proposed study are to test the usability, feasibility and preliminary efficacy of the E-Scale with wheelchair users. The E-scale was developed as a weight monitoring technology for wheelchair users. Up to fifteen overweight or obese wheelchair users will be enrolled in a 13 week study that includes standard behavioral treatment (SBT) for weight loss, which focuses on diet, physical activity, and behavioral strategies (e.g., goal setting, self-monitoring) to support lifestyle changes specifically for people with mobility impairments. The subjects will also be provided the E-scale to track their weight daily. The outcome measure include usefulness (subjective feedback from a survey about the program/E-scale), feasibility (accuracy and repeatable measurements from the E-scale) and efficacy (improvements in weight and other measures of health) of the weight loss program coupled with the E-scale at the end of 13 weeks. The primary hypothesis is that the E-scale coupled with the weight loss intervention will result in significant improvements in weight, abdominal girth, body fat percentage, and the Center for Epidemiologic Studies Depression Scale (CES-D).The results may inform the refinement of this technology to increase its applicability for wheelchair users to independently monitor their weight in their own homes while attempting to lose weight.
Wheelchair users have about twice the prevalence of obesity than the general population. There is also very little or no technology to which they have access to measure their weight frequently in their homes. Research however, has shown that monitoring your body weight frequently (i.e. daily) yields significantly better weight loss and weight maintenance results. This research has never included wheelchair users because they have not had access to technology to be able to measure their weight daily. The E-scale was developed as a weight monitoring technology for wheelchair users and has been tested for precision and accuracy in the laboratory. The goal of this study is to determine the usefulness, feasibility and efficacy of the E-scale system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users.
Up to fifteen overweight or obese wheelchair users will be enrolled in a 13 week study that includes standard behavioral treatment (SBT) for weight loss, which focuses on diet, physical activity, and behavioral strategies (e.g., goal setting, self-monitoring) to support lifestyle changes specifically for people with mobility impairments. The subjects will also be provided the E-scale to track their weight daily. The outcome measure include usefulness (subjective feedback from a survey about the program/E-scale), feasibility (accuracy and repeatable measurements from the E-scale) and efficacy (improvements in weight and other measures of health) of the weight loss program coupled with the E-scale at the end of 13 weeks.
Study hypotheses are:
Hypothesis 1: The E-scale will be useful based on self-reported feedback from wheelchair users by more than 50% stating that the E-scale is easy to use, their preferred weight monitoring system, them feeling that they would use the E-scale if it was available for them to purchase.
Hypothesis 2: The E-scale will be feasible by providing accurate (+/- 2 lbs. from a calibrated scale measurement) and repeatable (<3lbs difference from day-to-day) weight measurements and by the wheelchair users continuing to use the scale more than 70% of the days of the study.
Hypothesis 3: The E-scale coupled with the weight loss intervention will demonstrate efficacy by wheelchair users having significant improvements in weight, abdominal girth, body fat percentage, and the Center for Epidemiologic Studies Depression Scale (CES-D).
This research will determine whether wheelchair users find the E-scale to be useful and feasible as a way to monitor their weight in their homes. It will also show whether wheelchair users, like the general population, have better weight loss outcomes when they monitor their weight daily. This could lead to refinement of the E-scale and a push for more available technology for wheelchair users to monitor their weight at home which could in turn lead to a decrease in the prevalence of obesity among wheelchair users.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-Scale | Experimental | E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-Scale | Device | Daily bodyweight system used under legs of bed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change | Change in body weight | baseline and 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal Girth Change | Change in abdominal girth | baseline and 13 weeks |
| Body-fat Percentage Change | Change in body fat percentage | 13 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Pearlman, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15206 | United States |
Portions of the data may be made available upon request
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| ID | Title | Description |
|---|---|---|
| FG000 | E-Scale | E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users E-Scale: Daily bodyweight system used under legs of bed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | E-Scale | E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users E-Scale: Daily bodyweight system used under legs of bed |
| 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 | Weight Change | Change in body weight | Since there is only one group, this outcome variables was analyzed using summary statistics and paired t-tests. | Posted | Mean | Standard Deviation | pounds | baseline and 13 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 | E-Scale | E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users E-Scale: Daily bodyweight system used under legs of bed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan Pearlman | University of Pittsburgh | 412-822-3685 | jlp46@pitt.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 | Jun 5, 2018 | Mar 28, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 5, 2018 | Mar 28, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003863 | Depression |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Depression Score at Baseline | Depression scale determined by using the Center for Epidemiology Studies-Depression score. In scoring the CES-D, a value of 0, 1, 2 or 3 is assigned to a response depending upon whether the item is worded positively or negatively.. Possible range of scores is averaged to equal 0 to 60, with the higher scores indicating the presence of more symptomatology | Baseline only |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Initial Weight | Mean | Standard Deviation | lbs. |
|
| Initial BMI | Mean | Standard Deviation | kg/m^2 |
|
| Initial Abdominal Girth | Mean | Standard Deviation | inches |
|
| Initial Body Fat Percentage | Mean | Standard Deviation | percentage fat |
|
| Center for Epidemiologic Studies Scale | Depression scale determined by using the Center for Epidemiology Studies-Depression score. In scoring the CES-D, a value of 0, 1, 2 or 3 is assigned to a response depending upon whether the item is worded positively or negatively.. Possible range of scores is averaged to equal 0 to 60, with the higher scores indicating the presence of more symptomatology | Mean | Standard Deviation | units on a scale |
|
| Self-Rated Abilities for Health Practices Scale | Items are rated from 0 to 4. Total scores range from 0-112. Higher scores indicate greater self-efficacy for health practices | Mean | Standard Deviation | units on a scale |
|
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| Secondary | Abdominal Girth Change | Change in abdominal girth | Since there is only one group, this outcome variables was analyzed using summary statistics and paired t-tests. | Posted | Mean | Standard Deviation | inches | baseline and 13 weeks |
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| Secondary | Body-fat Percentage Change | Change in body fat percentage | Subject #7 only used the scale twice during the study therefore change in body fat percentage was not able to be calculated. Since there is only one group, this outcome variables was analyzed using summary statistics and paired t-tests. | Posted | Mean | Standard Deviation | percentage of pounds | 13 weeks |
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| Secondary | Depression Score at Baseline | Depression scale determined by using the Center for Epidemiology Studies-Depression score. In scoring the CES-D, a value of 0, 1, 2 or 3 is assigned to a response depending upon whether the item is worded positively or negatively.. Possible range of scores is averaged to equal 0 to 60, with the higher scores indicating the presence of more symptomatology | Outcome was only measured during baseline as a screening measurement, subjects were not eligible with a CES-D of > 20. Since there is only one group, this outcome variables was calculated using the CES-D scoring chart. | Posted | Mean | Standard Deviation | units on a scale | Baseline only |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |