What is the mechanism of action of this treatment?

Metabolic and bariatric surgery, such as gastric bypass or sleeve gastrectomy, primarily work by reducing the stomach's size, which limits food intake and alters gut hormones to promote satiety and improve insulin sensitivity. These surgeries can lead to significant weight loss and remission of obesity-related conditions like type 2 diabetes. When combined with behavioral strategies, such as dietary therapy, physical activity, and psychological support, the effectiveness of these surgeries is enhanced. This comprehensive approach helps patients maintain weight loss, adopt healthier lifestyles, and improve overall metabolic health, making it a crucial intervention for long-term obesity management.

What side effects are associated with this type of intervention?

Common treatments for obesity, particularly those involving metabolic and bariatric surgery combined with behavioral strategies, include procedures like gastric bypass and sleeve gastrectomy. Known side effects of these surgical treatments can include nutritional deficiencies (e.g., vitamin B12, iron), gastrointestinal issues (e.g., dumping syndrome, nausea, vomiting), and surgical complications (e.g., infections, hernias). Behavioral strategies, often involving dietary changes and increased physical activity, may lead to temporary side effects such as fatigue, muscle soreness, and gastrointestinal discomfort as the body adjusts to new routines.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of obesity, including orlistat, phentermine-topiramate, naltrexone-bupropion, and liraglutide. These medications are often used in conjunction with lifestyle interventions such as diet and exercise. Additionally, bariatric surgeries like Roux-en-Y gastric bypass and sleeve gastrectomy have been approved and are known to result in significant weight loss and metabolic improvements. These surgical options are often combined with behavioral strategies to enhance long-term success in weight management.

What other types of research exist?

Promising novel alternatives to Metabolic and Bariatric Surgery-supported Healthy Lifestyle Behavioral Intervention for obesity patients in 2024 include: 1) Pharmacotherapy with new medications such as GLP-1 receptor agonists (e.g., semaglutide) which have shown significant weight loss and metabolic benefits. 2) Endoscopic procedures like endoscopic sleeve gastroplasty (ESG) which are less invasive than traditional surgery and offer effective weight loss. 3) Advanced lifestyle interventions incorporating digital health tools and personalized nutrition plans to enhance adherence and outcomes.

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Behavioral Intervention

Healthy Lifestyle Intervention for Obesity in Teens (LIFT Trial)

N/A

Recruiting

Led By Sarah E Messiah, Ph.D., MPH

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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).

Must not have

Refuses to participate in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month pre surgery and 6 months post surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if combining weight-loss surgery with healthy living advice works well for teenagers who need extra help losing weight.

Who is the study for?

This trial is for teens with severe obesity, defined as having a BMI over 35 with related health issues like high blood pressure or cholesterol, or a BMI over 40. They must be considered candidates for bariatric surgery according to NIH guidelines and have received psychological clearance.

What is being tested?

The study tests a healthy lifestyle behavioral intervention supported by Metabolic and Bariatric Surgery (MBS) teams. It aims to see if this approach is feasible, acceptable, and effective in helping obese adolescents and their families make positive changes.

What are the potential side effects?

Since the intervention involves lifestyle changes rather than medication or invasive procedures, side effects may include typical challenges associated with diet change such as mood swings or fatigue but are generally minimal compared to medical interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am eligible for weight loss surgery based on my BMI and health conditions.

Select...

I am eligible for weight loss surgery based on my BMI and health conditions.

Select...

I have been cleared by a psychologist for surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not want to participate in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month pre surgery and 6 months post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month pre surgery and 6 months post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month pre surgery and 6 months post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Health-related quality of life as measured by the HRQOL-14

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Metabolic and bariatric surgery, such as gastric bypass or sleeve gastrectomy, primarily work by reducing the stomach's size, which limits food intake and alters gut hormones to promote satiety and improve insulin sensitivity. These surgeries can lead to significant weight loss and remission of obesity-related conditions like type 2 diabetes. When combined with behavioral strategies, such as dietary therapy, physical activity, and psychological support, the effectiveness of these surgeries is enhanced. This comprehensive approach helps patients maintain weight loss, adopt healthier lifestyles, and improve overall metabolic health, making it a crucial intervention for long-term obesity management.

Post-operative behavioural management in bariatric surgery: a systematic review and meta-analysis of randomized controlled trials.