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Trial Outcomes & Findings for Lifestyle Improvement for Teens With Bariatric Surgery (NCT NCT05393570)

NCT ID: NCT05393570

Last Updated: 2025-08-03

Results Overview

This survey includes 3 modules (Healthy Days Core Module = 4 questions, Activity Limitations Module = 5 questions, and the Healthy Days Symptoms Module = 5 questions). This survey is not based on a summary score. Instead to evaluate the score unhealthy days are the estimated total number of days in a 30 day period where participants felt their physical or mental health was not good. Survey responses from question 2 and 3 in the Healthy Days Core Module are combined to get overall unhealthy days.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

76 participants

Primary outcome timeframe

Pre-surgery, 6 months post-surgery

Results posted on

2025-08-03

Participant Flow

Adolescents were recruited from a single tertiary care center MBS program. Additionally, the clinic staff provided MBS program patient lists in EPIC. Adolescents were eligible if they met the National Institute of Health criteria for MBS, could communicate in English or Spanish, were between 12 and 18 years old, and had stable internet access or could access materials via smartphones. All participants underwent Laparoscopic Sleeve Gastrectomy.

Participant milestones

Participant milestones
Measure
Treatment
Adolescents who met the inclusion/exclusion criteria and consented to be participants in the study. Inclusion Criteria Must meet National Institutes of Health criteria to qualify for MBS for adolescents (BMI \>35 kg/m2 and at least one existing co-morbidity \[e.g., elevated blood pressure, hypercholesterolemia, etc.\] or a BMI\>40kg/m2). Received psychological clearance for surgery Exclusion Criteria: Is not medically referred by a physician for bariatric surgery Refuses to participate in the study
Overall Study
STARTED
76
Overall Study
COMPLETED
29
Overall Study
NOT COMPLETED
47

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lifestyle Improvement for Teens With Bariatric Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment
n=76 Participants
Adolescents who met the inclusion/exclusion criteria and consented to be participants in the study. Inclusion Criteria Must meet National Institutes of Health criteria to qualify for MBS for adolescents (BMI \>35 kg/m\^2 and at least one existing co-morbidity \[e.g., elevated blood pressure, hypercholesterolemia, etc.\] or a BMI\>40kg/m\^2). Received psychological clearance for surgery Exclusion Criteria: Is not medically referred by a physician for bariatric surgery Refuses to participate in the study
Age, Categorical
<=18 years
76 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
15.67 Years
STANDARD_DEVIATION 1.37 • n=5 Participants
Sex: Female, Male
Female
53 Participants
n=5 Participants
Sex: Female, Male
Male
23 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
43 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
29 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
23 Participants
n=5 Participants
Race (NIH/OMB)
White
27 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
24 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Body Mass Index (BMI)
48.27 kg/m^2
STANDARD_DEVIATION 8.32 • n=5 Participants

PRIMARY outcome

Timeframe: Pre-surgery, 6 months post-surgery

This survey includes 3 modules (Healthy Days Core Module = 4 questions, Activity Limitations Module = 5 questions, and the Healthy Days Symptoms Module = 5 questions). This survey is not based on a summary score. Instead to evaluate the score unhealthy days are the estimated total number of days in a 30 day period where participants felt their physical or mental health was not good. Survey responses from question 2 and 3 in the Healthy Days Core Module are combined to get overall unhealthy days.

Outcome measures

Outcome measures
Measure
MBS Completers
n=29 Participants
Adolescents who met the inclusion/exclusion criteria, consented to be participants in the study, and received MBS while participating in the study.
Change in Health-related Quality of Life as Measured by the HRQOL-14
-9 days
Standard Deviation 19.04

PRIMARY outcome

Timeframe: Pre surgery, 6 months post surgery

Cholesterol (mg/dL), HDL cholesterol (mg/dL), Triglycerides (mg/dL), LDL cholesterol (mg/dL), non-HDL cholesterol (mg/dL) change from pre-surgery to 6 months post-surgery.

Outcome measures

Outcome measures
Measure
MBS Completers
n=29 Participants
Adolescents who met the inclusion/exclusion criteria, consented to be participants in the study, and received MBS while participating in the study.
Change in Blood Lipid Levels as Assessed by Lipid Panel
LDL cholesterol
0.82 mg/dL
Standard Deviation 16.07
Change in Blood Lipid Levels as Assessed by Lipid Panel
Cholesterol
-3.97 mg/dL
Standard Deviation 23.22
Change in Blood Lipid Levels as Assessed by Lipid Panel
HDL cholesterol
4.36 mg/dL
Standard Deviation 7.55
Change in Blood Lipid Levels as Assessed by Lipid Panel
Triglycerides
-45.36 mg/dL
Standard Deviation 42.70
Change in Blood Lipid Levels as Assessed by Lipid Panel
non-HDL cholesterol
-8.18 mg/dL
Standard Deviation 21.93

PRIMARY outcome

Timeframe: pre surgery, 6 months post surgery

Measure of Blood Glucose (mg/dL) change from pre-surgery to 6 months post-surgery.

Outcome measures

Outcome measures
Measure
MBS Completers
n=29 Participants
Adolescents who met the inclusion/exclusion criteria, consented to be participants in the study, and received MBS while participating in the study.
Change in Blood Glucose Level
-2.3 (mg/dL)
Standard Deviation 11.17

PRIMARY outcome

Timeframe: pre surgery, 6 months post surgery

Measure diastolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery.

Outcome measures

Outcome measures
Measure
MBS Completers
n=29 Participants
Adolescents who met the inclusion/exclusion criteria, consented to be participants in the study, and received MBS while participating in the study.
Change in Diastolic Blood Pressure
-5 (mmHg)
Standard Deviation 12.50

PRIMARY outcome

Timeframe: pre surgery, 6 months post surgery

Measure systolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery.

Outcome measures

Outcome measures
Measure
MBS Completers
n=29 Participants
Adolescents who met the inclusion/exclusion criteria, consented to be participants in the study, and received MBS while participating in the study.
Change in Systolic Blood Pressure
-3.81 (mmHg)
Standard Deviation 16.22

PRIMARY outcome

Timeframe: pre surgery, 6 months post surgery

Measure HbA1c% (mmol/mol) levels in blood change from pre-surgery to 6 months post-surgery.

Outcome measures

Outcome measures
Measure
MBS Completers
n=29 Participants
Adolescents who met the inclusion/exclusion criteria, consented to be participants in the study, and received MBS while participating in the study.
Change in HbA1c Levels
-0.353 (mmol/mol)
Standard Deviation 0.297

Adverse Events

Treatment

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

Sarah E. Messiah

UTSW - O'Donnell School of Public Health

Phone: (972) 546-2919

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place