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Daily Weight Feedback for Wheelchair Users to Promote Weight Loss

Primary Purpose

Overweight and Obesity, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
E-Scale
Sponsored by
Jonathan Pearlman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring obesity, overweight, wheelchair

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

E-Scale

Arm Description

E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users

Outcomes

Primary Outcome Measures

Weight Change
Change in body weight

Secondary Outcome Measures

Abdominal Girth Change
Change in abdominal girth
Body-fat Percentage Change
Change in body fat percentage
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

Full Information

First Posted
August 2, 2017
Last Updated
May 20, 2019
Sponsor
Jonathan Pearlman
Collaborators
Paralyzed Veterans of America
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1. Study Identification

Unique Protocol Identification Number
NCT03264248
Brief Title
Daily Weight Feedback for Wheelchair Users to Promote Weight Loss
Official Title
Daily Self-weighing Feedback for Wheelchair Users to Promote Weight Loss Through Use of the E-scale
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
February 5, 2018 (Actual)
Study Completion Date
February 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jonathan Pearlman
Collaborators
Paralyzed Veterans of America

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Depression
Keywords
obesity, overweight, wheelchair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E-Scale
Arm Type
Experimental
Arm Description
E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users
Intervention Type
Device
Intervention Name(s)
E-Scale
Intervention Description
Daily bodyweight system used under legs of bed
Primary Outcome Measure Information:
Title
Weight Change
Description
Change in body weight
Time Frame
baseline and 13 weeks
Secondary Outcome Measure Information:
Title
Abdominal Girth Change
Description
Change in abdominal girth
Time Frame
baseline and 13 weeks
Title
Body-fat Percentage Change
Description
Change in body fat percentage
Time Frame
13 weeks
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Pearlman, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Portions of the data may be made available upon request

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Daily Weight Feedback for Wheelchair Users to Promote Weight Loss

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