What is the mechanism of action of this treatment?

Pharmacotherapy for childhood obesity primarily works by disrupting core pathophysiological processes and restoring homeostasis to the energy regulatory system. Medications such as metformin and GLP-1 receptor agonists (e.g., exenatide) help improve insulin sensitivity, reduce appetite, and enhance satiety, thereby facilitating weight loss and improving glycemic control. These treatments are crucial for childhood obesity patients as they address underlying biological factors that drive maladaptive behaviors like overeating, making it easier for patients to adhere to healthier lifestyle changes. Combining pharmacotherapy with behavioral interventions can lead to more sustainable weight management and better overall health outcomes.

What side effects are associated with this type of intervention?

Pharmacotherapy for childhood obesity, such as the use of medications like metformin, can lead to side effects including gastrointestinal issues (e.g., nausea, diarrhea), and in some cases, weight loss. Behavioral interventions, while generally safe, may face challenges with adherence and sustainability, potentially leading to diminished effectiveness over time. Combining pharmacotherapy with behavioral counseling can enhance outcomes but requires careful monitoring for side effects and long-term efficacy.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for the treatment of childhood obesity that aim to disrupt core pathophysiological processes and restore homeostasis to the energy regulatory system. These include medications like metformin, which is primarily used for type 2 diabetes but has shown efficacy in reducing weight gain associated with antipsychotic use in children. Other drugs, such as liraglutide, a GLP-1 receptor agonist, have been studied for their potential to aid in weight management by enhancing satiety and reducing appetite. While these medications are not exclusively approved for obesity, their mechanisms align with the goals of restoring energy balance and facilitating behavior change.

What other types of research exist?

Promising, novel alternatives to pharmacotherapy for childhood obesity include comprehensive, intensive behavioral interventions, mind-body therapies such as guided imagery, hypnosis, and biofeedback, and the use of dietary supplements like multivitamins, minerals, fish oils, and antioxidants. These approaches aim to address the underlying behavioral and physiological factors contributing to obesity and may offer effective, sustainable treatment options.

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Lifestyle Counseling + Medication for Childhood Obesity (QUEST Trial)

Phase 2

Recruiting

Led By Aaron Kelly, PhD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

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

Must have

Severe obesity (Body Mass Index (BMI) >/= 120% of the 95th percentile or BMI >/= 35 kg/m2)

Age 12 to < 18 years old and Tanner stage >1

Must not have

Diabetes (type 1 or 2)

Any history of treatment with growth hormone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Summary

This trial compares two treatments for adolescents with severe obesity. One group receives many counseling sessions to help change their habits, while the other group receives fewer sessions but also takes a medication to help control their appetite. The medication has been shown to promote weight loss by suppressing appetite and controlling eating habits.

Who is the study for?

Adolescents aged 12 to less than 18 with severe obesity, defined as a BMI at or above the 95th percentile for their age. They must not have diabetes, recent use of anti-obesity drugs, past bariatric surgery, certain psychiatric conditions, or be pregnant among other exclusions.

What is being tested?

The trial is testing whether semaglutide medication combined with a behavioral program can help manage weight in obese adolescents more effectively and sustainably compared to an intensive behavioral program alone.

What are the potential side effects?

Semaglutide may cause digestive issues like nausea and constipation, risk of low blood sugar levels (hypoglycemia), potential thyroid tumors, pancreatitis, gallbladder problems and allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am severely obese according to BMI standards.

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I am between 12 and 17 years old and have started puberty.

Exclusion Criteria

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

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I have diabetes (type 1 or 2).

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I have been treated with growth hormone in the past.

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I have had weight loss surgery in the past.

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I have a thyroid condition that hasn't been treated.

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I have a history of gallstones.

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I have had cancer within the last 5 years.

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My obesity is caused by a single gene mutation.

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I have a medical history of pancreatitis.

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I or my family have a history of thyroid cancer or MEN2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks 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 body mass index

Trial Design

2Treatment groups

Active Control

Group I: Intensive Behavioral Program ArmActive Control1 Intervention

Participants randomized to this arm of the study will receive intensive behavioral therapy. Participants will receive 52 weekly sessions (50% in person and 50% virtual).

Group II: Medication ArmActive Control1 Intervention

Participants randomized to this arm of the study will receive semaglutide and will receive behavioral therapy. Behavioral therapy will consist of 12 monthly sessions (50% in person and 50% virtual).

0 / 11Eligibility 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

Pharmacotherapy for childhood obesity primarily works by disrupting core pathophysiological processes and restoring homeostasis to the energy regulatory system. Medications such as metformin and GLP-1 receptor agonists (e.g., exenatide) help improve insulin sensitivity, reduce appetite, and enhance satiety, thereby facilitating weight loss and improving glycemic control. These treatments are crucial for childhood obesity patients as they address underlying biological factors that drive maladaptive behaviors like overeating, making it easier for patients to adhere to healthier lifestyle changes. Combining pharmacotherapy with behavioral interventions can lead to more sustainable weight management and better overall health outcomes.

Pharmacotherapy in Childhood Obesity.