Daily Weight Feedback for Wheelchair Users to Promote Weight Loss

NCT03264248 | Completed Results FDA Device

• 1 other identifier: PRO16110460
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Depression

Keywords

obesity; overweight; wheelchair

Outcome Measures

Primary Outcomes (1)

• Weight Change

  Change in body weight

  baseline and 13 weeks

Secondary Outcomes (3)

• Abdominal Girth Change

  baseline and 13 weeks

• Body-fat Percentage Change

  13 weeks

• Depression Score at Baseline

  Baseline only

Study Arms (1)

E-Scale

EXPERIMENTAL

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

Device: E-Scale

Interventions

E-Scale DEVICE

Daily bodyweight system used under legs of bed

E-Scale

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jonathan Pearlman: lead
• Paralyzed Veterans of America: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Depression

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Jonathan Pearlman
• Organization: University of Pittsburgh

jlp46@pitt.edu

412-822-3685

Study Officials

• Jon Pearlman, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 29, 2017
• Study Start: July 1, 2017
• Primary Completion: February 5, 2018
• Study Completion: February 9, 2018
• Last Updated: May 21, 2019
• Results First Posted: May 21, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)