N/A
N=9
Daily Weight Feedback for Wheelchair Users to Promote Weight Loss
Overweight and Obesity · Depression
Bottom Line
View on ClinicalTrials.gov: NCT03264248 ↗Enrolled (actual)
9
Serious AEs
—
Results posted
May 2019
Primary outcome: Primary: Weight Change — 196.0; 192.8 pounds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- E-Scale (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jonathan Pearlman
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Change |
196.0; 192.8 | — |
| SECONDARY Abdominal Girth Change |
45.1; 44.4 | — |
| SECONDARY Body-fat Percentage Change |
33.3; 32.9 | — |
| SECONDARY Depression Score at Baseline |
4.8 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03264248). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.