Trial Outcomes & Findings for Psychopathology, Disordered Eating, and Impulsivity as Predictors of Outcomes of Bariatric Surgery (NCT NCT02775071)
NCT ID: NCT02775071
Last Updated: 2024-05-16
Results Overview
percent weight change from baseline
COMPLETED
300 participants
6, 12, 24 months
2024-05-16
Participant Flow
Individuals interested in bariatric surgery attended an information session where the study was advertised. During a preoperative medical weight management visit with the program, the study was explained to patients. If they expressed interest, a brief screen was completed to assess eligibility. If patients met the inclusion criteria, they provided written informed consent to participate and were scheduled for study assessments. Recruitment occurred from 03/2016-11/2018.
We enrolled and assessed participants prior to bariatric surgery. Of the 300 enrolled, 281 underwent surgery, so 19 were not followed/contacted after the baseline assessment.
Participant milestones
| Measure |
Patients Seeking Bariatric Surgery
We recruited 300 individuals seeking laparoscopic Roux-en-y gastric bypass or sleeve gastrectomy procedure and assessed them at baseline, 6, 12, and 24+ months following surgery.
|
|---|---|
|
Overall Study
STARTED
|
300
|
|
Overall Study
COMPLETED
|
227
|
|
Overall Study
NOT COMPLETED
|
73
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psychopathology, Disordered Eating, and Impulsivity as Predictors of Outcomes of Bariatric Surgery
Baseline characteristics by cohort
| Measure |
Patients Seeking Bariatric Surgery
n=300 Participants
We recruited 300 individuals seeking laparoscopic Roux-en-y gastric bypass or sleeve gastrectomy procedure and assessed them at baseline, 6, 12, and 24+ months following surgery.
|
|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
260 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
224 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
179 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
300 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6, 12, 24 monthsPopulation: We had 245 participants at 6 months, 224 participants at 12 months, and 227 participants at 24 months complete a weight measurement that was available to compute percent weight change from baseline.
percent weight change from baseline
Outcome measures
| Measure |
Patients Seeking Bariatric Surgery
n=245 Participants
We recruited 300 individuals seeking laparoscopic Roux-en-y gastric bypass or sleeve gastrectomy procedure and assessed them at baseline, 6, 12, and 24+ months following surgery.
|
|---|---|
|
Percent Weight Change
% wt change at 6 mos
|
23.0 percent weight change
Standard Deviation 5.1
|
|
Percent Weight Change
% wt change at 12 mos
|
26.2 percent weight change
Standard Deviation 7.7
|
|
Percent Weight Change
% wt change at 24 mos
|
23.3 percent weight change
Standard Deviation 9.9
|
Adverse Events
Patients Seeking Bariatric Surgery
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place