Trial Outcomes & Findings for Daily Weight Feedback for Wheelchair Users to Promote Weight Loss (NCT NCT03264248)

NCT ID: NCT03264248

Last Updated: 2019-05-21

Results Overview

Change in body weight

Recruitment status

COMPLETED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

baseline and 13 weeks

Results posted on

2019-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Daily Weight Feedback for Wheelchair Users to Promote Weight Loss

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	E-Scale n=9 Participants 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
Age, Continuous	48.8 years STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants
Initial Weight	196.0 lbs. STANDARD_DEVIATION 38.0 • n=5 Participants
Initial BMI	33.6 kg/m^2 STANDARD_DEVIATION 3.7 • n=5 Participants
Initial Abdominal Girth	45.1 inches STANDARD_DEVIATION 5.6 • n=5 Participants
Initial Body Fat Percentage	33.3 percentage fat STANDARD_DEVIATION 10.5 • n=5 Participants
Center for Epidemiologic Studies Scale	4.8 units on a scale STANDARD_DEVIATION 3.6 • n=5 Participants
Self-Rated Abilities for Health Practices Scale	90.6 units on a scale STANDARD_DEVIATION 8.3 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 13 weeks

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

Change in body weight

Outcome measures

Outcome measures
Measure	E-Scale n=9 Participants 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
Weight Change Baseline	196.0 pounds Standard Deviation 38.0
Weight Change Final	192.8 pounds Standard Deviation 36.4

SECONDARY outcome

Timeframe: baseline and 13 weeks

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

Change in abdominal girth

Outcome measures

Outcome measures
Measure	E-Scale n=9 Participants 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
Abdominal Girth Change Baseline	45.1 inches Standard Deviation 4.8
Abdominal Girth Change Final	44.4 inches Standard Deviation 4.8

SECONDARY outcome

Timeframe: 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.

Change in body fat percentage

Outcome measures

Outcome measures
Measure	E-Scale n=8 Participants 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
Body-fat Percentage Change Baseline	33.3 percentage of pounds Standard Deviation 10.5
Body-fat Percentage Change Final	32.9 percentage of pounds Standard Deviation 9.8

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	E-Scale n=9 Participants 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
Depression Score at Baseline	4.8 units on a scale Standard Deviation 3.6

Adverse Events

E-Scale

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jonathan Pearlman

University of Pittsburgh

Phone: 412-822-3685

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place