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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD105129-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Lifestyle Behavioral Intervention (MBS -supported intervention) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-surgery, 6 months post-surgery |
| 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. | Pre surgery, 6 months post surgery |
| Change in Blood Glucose Level | Measure of Blood Glucose (mg/dL) change from pre-surgery to 6 months post-surgery. | pre surgery, 6 months post surgery |
| Change in Diastolic Blood Pressure | Measure diastolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery. | pre surgery, 6 months post surgery |
| Change in Systolic Blood Pressure | Measure systolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery. | pre surgery, 6 months post surgery |
| Change in HbA1c Levels | Measure HbA1c% (mmol/mol) levels in blood change from pre-surgery to 6 months post-surgery. |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah E Messiah, Ph.D., MPH | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42151385 | Derived | Allicock MA, Francis JM, Neti S, Polavarapu D, Misserian M, Mathew MS, Wheelington A, Braxton R, Cartwright BR, Qureshi FG, Atem F, Barlow SE, Messiah SE. Evaluation of a behavioral intervention to support adolescents undergoing bariatric surgery using the reach, effectiveness, adoption, implementation, maintenance (RE-AIM) framework. Sci Rep. 2026 May 18. doi: 10.1038/s41598-026-50810-w. Online ahead of print. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Years (Self-reported) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | days | Pre-surgery, 6 months post-surgery |
|
Enrollment to 6-month post-surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah E. Messiah | UTSW - O'Donnell School of Public Health | (972) 546-2919 | Sarah.Messiah@UTSouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2025 | Jun 11, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
| pre surgery, 6 months post surgery |
| Participants |
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| Age, Continuous | Years (Self-reported) | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Sex (Self-reported) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity (Self-reported) | Count of Participants | Participants |
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| Race (NIH/OMB) | Race (Self-reported) | Count of Participants | Participants |
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| Body Mass Index (BMI) | BMI (kg/m2) at enrollment | Mean | Standard Deviation | kg/m^2 |
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| Units | Counts |
|---|---|
| Participants |
|
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| 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. | Posted | Mean | Standard Deviation | mg/dL | Pre surgery, 6 months post surgery |
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| Primary | Change in Blood Glucose Level | Measure of Blood Glucose (mg/dL) change from pre-surgery to 6 months post-surgery. | Posted | Mean | Standard Deviation | (mg/dL) | pre surgery, 6 months post surgery |
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| Primary | Change in Diastolic Blood Pressure | Measure diastolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery. | Posted | Mean | Standard Deviation | (mmHg) | pre surgery, 6 months post surgery |
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| Primary | Change in Systolic Blood Pressure | Measure systolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery. | Posted | Mean | Standard Deviation | (mmHg) | pre surgery, 6 months post surgery |
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| Primary | Change in HbA1c Levels | Measure HbA1c% (mmol/mol) levels in blood change from pre-surgery to 6 months post-surgery. | Posted | Mean | Standard Deviation | (mmol/mol) | pre surgery, 6 months post surgery |
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| 0 |
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title |
|---|
| Measurements |
|---|
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| LDL cholesterol |
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| non-HDL cholesterol |
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