Daily Weight Feedback for Wheelchair Users to Promote Weight Loss

• Sponsor: Jonathan Pearlman (Other)
• Overall Status: Completed
• CT.gov ID: NCT03264248
• Collaborator: Paralyzed Veterans of America (Other)
• Enrollment: 9
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity; Depression	Device: E-Scale	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Daily Self-weighing Feedback for Wheelchair Users to Promote Weight Loss Through Use of the E-scale
• Actual Study Start Date: Jul 1, 2017
• Actual Primary Completion Date: Feb 5, 2018
• Actual Study Completion Date: Feb 9, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: E-Scale 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

Outcome Measures

Primary Outcome Measures

1. Weight Change [baseline and 13 weeks]

   Change in body weight

Secondary Outcome Measures

1. Abdominal Girth Change [baseline and 13 weeks]

   Change in abdominal girth

2. Body-fat Percentage Change [13 weeks]

   Change in body fat percentage

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15206

Sponsors and Collaborators

• Jonathan Pearlman
• Paralyzed Veterans of America

Investigators

• Principal Investigator: Jon Pearlman, PhD, University of Pittsburgh

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 5, 2018
• Informed Consent Form - Jun 5, 2018

More Information

Publications

None provided.

• Responsible Party: Jonathan Pearlman, Associate Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03264248
• Other Study ID Numbers: PRO16110460
• First Posted: Aug 29, 2017
• Last Update Posted: May 21, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Jonathan Pearlman, Associate Professor, University of Pittsburgh: obesity; overweight; wheelchair
• Additional relevant MeSH terms: Overweight; Weight Loss

Study Results

Participant Flow

Arm/Group Title	E-Scale
Arm/Group Description	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
Period Title: Overall Study
STARTED	9
COMPLETED	9
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	E-Scale
Arm/Group Description	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
Overall Participants	9
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.8 (15.6)
Sex: Female, Male (Count of Participants)
Female	4 44.4%
Male	5 55.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	9 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	9 100%
Initial Weight (lbs.) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [lbs.]	196.0 (38.0)
Initial BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	33.6 (3.7)
Initial Abdominal Girth (inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [inches]	45.1 (5.6)
Initial Body Fat Percentage (percentage fat) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage fat]	33.3 (10.5)
Center for Epidemiologic Studies Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.8 (3.6)
Self-Rated Abilities for Health Practices Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	90.6 (8.3)

Outcome Measures

1. Primary Outcome

Title	Weight Change
Description	Change in body weight
Time Frame	baseline and 13 weeks

Outcome Measure Data

Analysis Population Description

Since there is only one group, this outcome variables was analyzed using summary statistics and paired t-tests.

Arm/Group Title	E-Scale
Arm/Group Description	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
Measure Participants	9
Baseline	196.0 (38.0)
Final	192.8 (36.4)

2. Secondary Outcome

Title	Abdominal Girth Change
Description	Change in abdominal girth
Time Frame	baseline and 13 weeks

Outcome Measure Data

Analysis Population Description

Since there is only one group, this outcome variables was analyzed using summary statistics and paired t-tests.

Arm/Group Title	E-Scale
Arm/Group Description	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
Measure Participants	9
Baseline	45.1 (4.8)
Final	44.4 (4.8)

3. Secondary Outcome

Title	Body-fat Percentage Change
Description	Change in body fat percentage
Time Frame	13 weeks

Outcome Measure Data

Analysis Population Description

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/Group Title	E-Scale
Arm/Group Description	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
Measure Participants	8
Baseline	33.3 (10.5)
Final	32.9 (9.8)

4. Secondary Outcome

Title	Depression Score at Baseline
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	E-Scale
Arm/Group Description	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
Measure Participants	9
Mean (Standard Deviation) [units on a scale]	4.8 (3.6)

Adverse Events

Time Frame	Not collected for this study
Adverse Event Reporting Description	Not collected for this study
Arm/Group Title	E-Scale
Arm/Group Description	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
All Cause Mortality
	E-Scale
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	E-Scale
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	E-Scale
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.