An interventional study of E-Scale in Overweight and Obesity and Depression, sponsored by Jonathan Pearlman. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-05-21.
Sponsored by Jonathan Pearlman · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users
Device: E-Scale
Daily bodyweight system used under legs of bed
Weight Change
Change in body weight
Time frame: baseline and 13 weeks
Abdominal Girth Change
Change in abdominal girth
Time frame: baseline and 13 weeks
Body-fat Percentage Change
Change in body fat percentage
Time frame: 13 weeks
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
Time frame: Baseline only
| Milestone | E-Scale |
|---|---|
| Started | 9 |
| Completed | 9 |
| Not completed | 0 |
Change in body weight
| pounds | E-Scale |
|---|---|
| Baseline | 196.0 ± 38.0 |
| Final | 192.8 ± 36.4 |
Change in abdominal girth
| inches | E-Scale |
|---|---|
| Baseline | 45.1 ± 4.8 |
| Final | 44.4 ± 4.8 |
Change in body fat percentage
| percentage of pounds | E-Scale |
|---|---|
| Baseline | 33.3 ± 10.5 |
| Final | 32.9 ± 9.8 |
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
| units on a scale | E-Scale |
|---|---|
| Depression Score at Baseline | 4.8 ± 3.6 |
Collected over Not collected for this study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| E-Scale | — | — | — |
| Age, Continuous(years) | E-Scale |
|---|---|
| Mean | 48.8 ± 15.6 |
| Sex: Female, Male(Participants) | E-Scale |
|---|---|
| Female | 4 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | E-Scale |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | E-Scale |
|---|---|
| United States | 9 |
| Initial Weight(lbs.) | E-Scale |
|---|---|
| Mean | 196.0 ± 38.0 |
| Initial BMI(kg/m^2) | E-Scale |
|---|---|
| Mean | 33.6 ± 3.7 |
| Initial Abdominal Girth(inches) | E-Scale |
|---|---|
| Mean | 45.1 ± 5.6 |
| Initial Body Fat Percentage(percentage fat) | E-Scale |
|---|---|
| Mean | 33.3 ± 10.5 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Portions of the data may be made available upon request
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Jonathan Pearlman