Obesity, AdolescentLIFTNCT05393570
Lifestyle Improvement for Teens With Bariatric Surgery
A study testing Healthy Lifestyle Behavioral Intervention (MBS -supported intervention) in people with Obesity, Adolescent and Bariatric Surgery Candidate, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent, Bariatric Surgery Candidate
- What is being tested?
- Healthy Lifestyle Behavioral Intervention (MBS -supported intervention)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2022to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- is not medically referred by a physician for bariatric surgery
- Refuses to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Partnering Lifestyle Intervention With Bariatric Surgery to Maximize Health Outcomes in Adolescents
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.
Read the 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.
- Conditions
- Obesity, Adolescent, Bariatric Surgery Candidate
- Being tested
- Healthy Lifestyle Behavioral Intervention (MBS -supported intervention)
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Lifestyle Behavioral Intervention (MBS -supported intervention)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Behavioral: Healthy Lifestyle Behavioral Intervention (MBS -supported intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pre surgery, 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start7 Mar 2022
- Primary completion1 Sep 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, AdolescentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sarah E Messiah, The University of Texas Health Science Center, Houston
- Investigators
- Sarah E Messiah, Ph.D., MPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393570
- Sponsor's protocol ID
- HSC-SPH-19-0406
- Other IDs
- 1R21HD105129-01A1
- Acronym
- LIFT
- Status last verified
- Jul 2025
- First submitted
- 16 May 2022
- Last updated
- 3 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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;16(1):22468. doi: 10.1038/s41598-026-50810-w.
PubMed 42151385
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnering Lifestyle Intervention With Bariatric Surgery to Maximize Health Outcomes in Adolescents
- ClinicalTrials.gov ID
- NCT05393570
- Acronym / sponsor ID
- LIFT / HSC-SPH-19-0406
- Conditions
- Obesity, Adolescent, Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Posted 3 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Healthy Lifestyle Behavioral Intervention (MBS -supported intervention) |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- is not medically referred by a physician for bariatric surgery
- Refuses to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy 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. | Behavioural | Treatment |
Primary outcome
Change in Health-related Quality of Life as Measured by the HRQOL-14
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: pre surgery, 6 months post surgery
Measure systolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery.
Change in HbA1c Levels
Time frame: pre surgery, 6 months post surgery
Measure HbA1c% (mmol/mol) levels in blood change from pre-surgery to 6 months post-surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42151385Allicock 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;16(1):22468. doi: 10.1038/s41598-026-50810-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah E Messiah, Ph.D., MPH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Lifestyle Behavioral Intervention (MBS -supported intervention) in people with Obesity, Adolescent and Bariatric Surgery Candidate, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health-related Quality of Life as Measured by the HRQOL-14 (time frame: Pre-surgery, 6 months post-surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05393570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.