Depression, Overweight and Obesity
Conditions
Keywords
obesity, overweight, wheelchair
Brief summary
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.
Detailed description
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.
Interventions
DEVICEE-Scale
Daily bodyweight system used under legs of bed
Sponsors
Paralyzed Veterans of America
Jonathan Pearlman
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Use Wheelchair as primary means of mobility * Uses a bed with 4 legs * Body mass index (BMI) ≥27 and ≤40.0 * Has daily access to Internet * Currently owns or willing to use an android device * Provides physician clearance to participate in a weight loss intervention * Speaks English
Exclusion criteria
* Presence of an unstable condition requiring physician-supervised diet and exercise (e.g., diabetes, recent myocardial infarction) * Presence of condition precluding engagement in exercise at moderate intensity (e.g., asthma, congestive heart failure, etc.) * Pregnancy or intention to become pregnant during study * Currently being treated for any psychological issues or problems, taking any psychotropic medications, or receiving treatment with psychotropic medications within the previous 6 months * Reported alcohol intake \> 4 drinks/day * Reported participation in a formal weight loss program, loss of ≥5% weight in the past 6 months, or current use of weight loss medication. * History of bariatric surgery (lap-band, gastric bypass, etc.) * Planned extended vacations, absences, or relocation during study * A score ≥20 on the Center for Epidemiologic Studies Depression Scale (CES-D) * A classification of Anorexia Nervosa, Bulimia Nervosa or Binge Eating Disorder on the Eating Disorder Diagnosis Scale (EDDS)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change | baseline and 13 weeks | Change in body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal Girth Change | baseline and 13 weeks | Change in abdominal girth |
| Body-fat Percentage Change | 13 weeks | Change in body fat percentage |
| Depression Score at Baseline | Baseline only | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | E-Scale |
|---|---|
| Age, Continuous | 48.8 years STANDARD_DEVIATION 15.6 |
| Center for Epidemiologic Studies Scale | 4.8 units on a scale STANDARD_DEVIATION 3.6 |
| Initial Abdominal Girth | 45.1 inches STANDARD_DEVIATION 5.6 |
| Initial BMI | 33.6 kg/m^2 STANDARD_DEVIATION 3.7 |
| Initial Body Fat Percentage | 33.3 percentage fat STANDARD_DEVIATION 10.5 |
| Initial Weight | 196.0 lbs. STANDARD_DEVIATION 38 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 9 participants |
| Self-Rated Abilities for Health Practices Scale | 90.6 units on a scale STANDARD_DEVIATION 8.3 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Weight Change
Change in body weight
Time frame: baseline and 13 weeks
Population: Since there is only one group, this outcome variables was analyzed using summary statistics and paired t-tests.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-Scale | Weight Change | Baseline | 196.0 pounds | Standard Deviation 38 |
| E-Scale | Weight Change | Final | 192.8 pounds | Standard Deviation 36.4 |
Secondary
Abdominal Girth Change
Change in abdominal girth
Time frame: baseline and 13 weeks
Population: Since there is only one group, this outcome variables was analyzed using summary statistics and paired t-tests.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-Scale | Abdominal Girth Change | Baseline | 45.1 inches | Standard Deviation 4.8 |
| E-Scale | Abdominal Girth Change | Final | 44.4 inches | Standard Deviation 4.8 |
Secondary
Body-fat Percentage Change
Change in body fat percentage
Time frame: 13 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-Scale | Body-fat Percentage Change | Baseline | 33.3 percentage of pounds | Standard Deviation 10.5 |
| E-Scale | Body-fat Percentage Change | Final | 32.9 percentage of pounds | Standard Deviation 9.8 |
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
Time frame: Baseline only
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-Scale | Depression Score at Baseline | 4.8 units on a scale | Standard Deviation 3.6 |