Bariatric Surgery Candidate, Obesity, Adolescent
Conditions
Brief summary
This study aims to conduct a proof-of-concept study to assess the feasibility, acceptability, and effectiveness of a Metabolic and bariatric surgery (MBS) -supported healthy lifestyle behavioral intervention among adolescent patients, their families, and their clinical team.
Detailed description
This proof-of-concept study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a lifestyle behavioral intervention integrated with metabolic and bariatric surgery (MBS) for adolescents with severe obesity. Targeting youth aged 12-18, the intervention is designed to enhance pre- and post-operative outcomes by supporting sustained healthy behaviors among patients and their families. Guided by formative qualitative research (AIM 1), the team will adapt an evidence-based multimedia lifestyle program (AIM 2) to align with adolescent MBS patients' unique needs and preferences. The adapted intervention will then be pilot-tested (AIM 3) among adolescent patients at a large adolescent healthcare system, with participants followed up to 12 months post-surgery. The program includes online components delivered before and after surgery, with progress evaluated at multiple time points. In addition to anthropometric and cardiometabolic outcomes, the study will assess intervention engagement, satisfaction, and delivery fidelity using the RE-AIM framework. The overarching goal is to demonstrate that combining lifestyle support with MBS can improve adherence, reduce attrition, and enhance long-term health outcomes among adolescents with severe obesity.
Interventions
BEHAVIORALHealthy Lifestyle Behavioral Intervention (MBS -supported intervention)
After patient/parent consent is completed, participants will begin the pre-MBS intervention phase. A minimum of 6 1- hour sessions will occur pre-MBS, and 26 will occur post-MBS.Dr. Klement, MBS coordinator and a diabetes educator will manage session delivery to adolescents/parents. All content will follow the Diabetes Prevention Program (DPP)-adapted curriculum flow. After that the research assistant will perform outreach, reminder calls, and follow-up for missed appointments. Pre-and post-MBS intervention delivery (based on adapted curriculum/model) may consist of a combination of 1-on-1 and group sessions (in-person or virtually), and online support tools, dependent upon adolescent/parent qualitative feedback on delivery method preference.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health-related Quality of Life as Measured by the HRQOL-14 | 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. |
| Change in Blood Lipid Levels as Assessed by Lipid Panel | 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. |
| Change in Blood Glucose Level | pre surgery, 6 months post surgery | Measure of Blood Glucose (mg/dL) change from pre-surgery to 6 months post-surgery. |
| Change in Diastolic Blood Pressure | pre surgery, 6 months post surgery | Measure diastolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery. |
| Change in Systolic Blood Pressure | pre surgery, 6 months post surgery | Measure systolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery. |
| Change in HbA1c Levels | pre surgery, 6 months post surgery | Measure HbA1c% (mmol/mol) levels in blood change from pre-surgery to 6 months post-surgery. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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/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 | 76 |
| Total | 76 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 76 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 15.67 Years STANDARD_DEVIATION 1.37 |
| Body Mass Index (BMI) | 48.27 kg/m^2 STANDARD_DEVIATION 8.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 24 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 76 |
| other Total, other adverse events | 0 / 76 |
| serious Total, serious adverse events | 0 / 76 |
Outcome results
Primary
Change in Blood Glucose Level
Measure of Blood Glucose (mg/dL) change from pre-surgery to 6 months post-surgery.
Time frame: pre surgery, 6 months post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MBS Completers | Change in Blood Glucose Level | -2.3 (mg/dL) | Standard Deviation 11.17 |
Primary
Change in Blood Lipid Levels as Assessed by Lipid Panel
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.
Time frame: Pre surgery, 6 months post surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBS Completers | Change in Blood Lipid Levels as Assessed by Lipid Panel | Cholesterol | -3.97 mg/dL | Standard Deviation 23.22 |
| MBS Completers | Change in Blood Lipid Levels as Assessed by Lipid Panel | HDL cholesterol | 4.36 mg/dL | Standard Deviation 7.55 |
| MBS Completers | Change in Blood Lipid Levels as Assessed by Lipid Panel | Triglycerides | -45.36 mg/dL | Standard Deviation 42.7 |
| MBS Completers | Change in Blood Lipid Levels as Assessed by Lipid Panel | LDL cholesterol | 0.82 mg/dL | Standard Deviation 16.07 |
| MBS Completers | Change in Blood Lipid Levels as Assessed by Lipid Panel | non-HDL cholesterol | -8.18 mg/dL | Standard Deviation 21.93 |
Primary
Change in Diastolic Blood Pressure
Measure diastolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery.
Time frame: pre surgery, 6 months post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MBS Completers | Change in Diastolic Blood Pressure | -5 (mmHg) | Standard Deviation 12.5 |
Primary
Change in HbA1c Levels
Measure HbA1c% (mmol/mol) levels in blood change from pre-surgery to 6 months post-surgery.
Time frame: pre surgery, 6 months post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MBS Completers | Change in HbA1c Levels | -0.353 (mmol/mol) | Standard Deviation 0.297 |
Primary
Change in Health-related Quality of Life as Measured by the HRQOL-14
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.
Time frame: Pre-surgery, 6 months post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MBS Completers | Change in Health-related Quality of Life as Measured by the HRQOL-14 | -9 days | Standard Deviation 19.04 |
Primary
Change in Systolic Blood Pressure
Measure systolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery.
Time frame: pre surgery, 6 months post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MBS Completers | Change in Systolic Blood Pressure | -3.81 (mmHg) | Standard Deviation 16.22 |