Lifestyle Counseling + Medication for Childhood Obesity

(QUEST Trial)

Overseen By Aaron Kelly, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Minnesota

Must not be taking: Anti-obesity medications

Disqualifiers: Diabetes, Bariatric surgery, Psychiatric disorder, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 64

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used anti-obesity medications in the last 6 months.

Is the treatment of lifestyle counseling and medication for childhood obesity safe?

The safety of medications like liraglutide (Saxenda) for obesity has been evaluated, and while they are approved for use, they come with potential side effects. Regulatory agencies like the FDA require safety trials and monitor for serious side effects, such as cardiovascular issues, to ensure these medications are safe for use. ^{1 2 3 4 5}

How does the drug used in the Lifestyle Counseling + Medication for Childhood Obesity trial differ from other treatments for childhood obesity?

This treatment combines lifestyle counseling with newer anti-obesity medications that have shown more significant weight loss results (5-18% improvement) compared to traditional methods, which typically achieve only 1-3% improvement. These medications are part of a newer class of drugs that are not yet widely used in children, offering a novel approach to managing childhood obesity. ^{1 6 7 8 9}

What data supports the effectiveness of the drug treatment for childhood obesity?

The research highlights a gap in effective drug treatments for pediatric obesity, with limited FDA-approved options and modest effects from single drugs. However, combination drug therapies, which have shown greater weight loss in adults, may offer better outcomes for children as well. ^{1 10 11 12 13}

Who Is on the Research Team?

Aaron Kelly, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am severely obese according to BMI standards.

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

Exclusion Criteria

Medically-documented history of bulimia nervosa

I have diabetes (type 1 or 2).

I have been treated with growth hormone in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intensive Behavioral Program

Participants receive 52 weeks of intensive behavioral therapy, with 52 contact hours (50% in person and 50% virtual)

52 weeks

52 visits (26 in-person, 26 virtual)

Medication Arm

Participants receive semaglutide and 12 monthly sessions of behavioral therapy (50% in person and 50% virtual)

52 weeks

12 visits (6 in-person, 6 virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intensive Behavioral Program
• Liraglutide
• Semaglutide

Trial Overview 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.

How Is the Trial Designed?

Group I: Intensive Behavioral Program Arm Active Control 1 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 Arm Active Control 1 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).

Intensive Behavioral Program is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Victoza for:

• Type 2 diabetes
• Chronic obesity

Approved in United States as Victoza/Saxenda for:

• Type 2 diabetes
• Chronic obesity in adults and adolescents aged 12-17 years

Approved in Canada as Victoza/Saxenda for:

• Type 2 diabetes
• Chronic obesity

Approved in Japan as Victoza/Saxenda for:

• Type 2 diabetes
• Chronic obesity

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

In a study analyzing 38,539 pediatric visits, it was found that children prescribed psychotropic medications were more likely to have obesity identified during their visits, with an odds ratio of 5.2, indicating a significant association between these medications and obesity identification.

Despite the increased risk of weight gain in children on psychotropic medications, only 11.4% received dietary counseling, highlighting a gap in care and the need for better management of obesity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification and counseling for obesity among children on psychotropic medications in ambulatory settings. Eneli, IU., Wang, W., Kelleher, K.[2013]

Effective treatment for childhood and adolescent obesity requires a comprehensive initial assessment, including medical history and physical examination, with management strategies focusing on comorbidities, family involvement, and behavior change techniques.

Medications like Orlistat and Metformin can support lifestyle changes in severely obese adolescents and those with insulin resistance, respectively, while bariatric surgery may be an option for severely obese patients, emphasizing the need for specialized care in experienced centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment and management of obesity in childhood and adolescence. Baur, LA., Hazelton, B., Shrewsbury, VA.[2021]

Combination pharmacotherapy, such as using phentermine and topiramate together, may provide better weight loss results for pediatric patients with obesity compared to single-agent treatments, which often have limited efficacy.

This case report of a 10-year-old girl illustrates the potential benefits of combining medications after lifestyle modifications were insufficient, highlighting the need for more effective treatment options in pediatric obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential Role of Combination Pharmacotherapy to Improve Outcomes of Pediatric Obesity: A Case Report and Discussion. Fox, CK., Kelly, AS.[2020]

A survey of 1300 Pediatric Endocrine Society members revealed that only 19% of practitioners prescribed weight-loss medications for pediatric obesity, with Metformin being the most common choice, but responses to medication were generally poor.

Practitioners from the Pediatric Obesity Weight Evaluation Registry were more likely to prescribe weight-loss medications (46%) compared to those from the Pediatric Endocrine Society (18%), highlighting a significant variation in treatment practices and the need for more effective pharmacological and surgical options for managing pediatric obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in pediatric obesity management, a survey from the Pediatric Endocrine Society Obesity Committee. Shoemaker, AH., Chung, ST., Fleischman, A.[2021]

There is a significant treatment gap for adolescents with severe obesity, as current options mainly include intensive lifestyle changes or surgery, while the use of obesity medications remains underutilized despite their recent approval for adults.

The review highlights the need for better understanding and application of obesity pharmacotherapy in youth, addressing safety, efficacy, and legal considerations to improve treatment strategies for obesity-related comorbidities in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Considerations Regarding the Use of Obesity Pharmacotherapy in Adolescents with Obesity. Srivastava, G., Fox, CK., Kelly, AS., et al.[2023]

Orlistat is a safe and effective weight loss medication for adolescents aged 12 to 16, showing significant reductions in body mass index (BMI) in most studies, although it can cause gastrointestinal side effects and lower fat-soluble vitamin levels.

Sibutramine also effectively reduces BMI in overweight adolescents, with reductions up to 5.6 kg/m2, but raises concerns due to potential serious side effects like increased blood pressure and suicidal ideation, necessitating further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapeutic options for overweight adolescents. Dunican, KC., Desilets, AR., Montalbano, JK.[2018]

A pilot study involving 30 adolescents with severe obesity showed that 4 weeks of meal replacement therapy followed by 24 weeks of topiramate did not lead to a significant reduction in BMI compared to a placebo group.

However, the topiramate group experienced notable improvements in visceral fat and cholesterol levels, with no adverse effects on neurocognitive function or bone health, suggesting potential metabolic benefits despite the lack of significant weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meal replacements followed by topiramate for the treatment of adolescent severe obesity: A pilot randomized controlled trial. Fox, CK., Kaizer, AM., Rudser, KD., et al.[2018]

Four new obesity drug therapies approved by the FDA since 2012—lorcaserin, phentermine/topiramate, naltrexone/bupropion, and liraglutide 3.0 mg—can lead to weight loss of about 3 to 9% beyond lifestyle changes after one year.

The effectiveness of these drugs varies among individuals, highlighting the importance of personalized treatment plans that consider the benefits and risks for each patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of Obesity: Clinical Trials to Clinical Practice. Gadde, KM., Pritham Raj, Y.[2018]

Many weight loss medications have been withdrawn due to serious adverse effects, such as cardiovascular toxicity and neuro-psychiatric issues, which has influenced the current drug development and approval process for anti-obesity drugs.

Regulatory strategies by the FDA, including risk evaluation programs and post-marketing safety trials, aim to manage potential serious side effects of new weight-reducing medications, leading to discrepancies in drug availability between the USA and Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of pharmacological obesity treatments: focus on adverse side-effect profiles. Krentz, AJ., Fujioka, K., Hompesch, M.[2017]

New anti-obesity medications (AOMs) are significantly improving obesity management in children and adolescents, achieving weight reductions of 5-18% of the 95th percentile of BMI, compared to the 1-3% improvements seen with traditional behavioral therapies.

Early and aggressive use of AOMs, combined with ongoing care and shared decision-making between healthcare providers and families, is crucial for optimizing treatment outcomes in pediatric obesity, especially in patients with complex medical and behavioral needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical review: Guide to pharmacological management in pediatric obesity medicine. O'Hara, V., Cuda, S., Kharofa, R., et al.[2023]

Both short-stay (2 months) and long-stay (6 months) intensive lifestyle treatments for severely obese children resulted in significant reductions in SDS-BMI after one year, indicating that both approaches are effective.

There were no significant differences in outcomes between the two treatment durations, suggesting that the shorter treatment may be preferable due to its lower burden on children and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year effects of two intensive inpatient treatments for severely obese children and adolescents. Makkes, S., Renders, CM., Bosmans, JE., et al.[2023]

Lifestyle modifications are the first recommended approach for obesity treatment, but achieving long-term weight loss through these methods alone is challenging.

For long-term obesity management, the only FDA-approved medications, sibutramine and orlistat, lead to an additional 3% to 5% weight loss compared to placebo after one year, while bariatric surgery is a viable option for patients with a BMI of 40 or higher, or 35-39.9 with severe obesity-related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fundamentals of cardiometabolic risk factor reduction: achieving and maintaining weight loss with pharmacotherapy or bariatric surgery. Fabbrini, E., Klein, S.[2019]

Antiobesity medications can support weight management in conjunction with a balanced diet and exercise, particularly for patients with obesity or overweight who have related health issues, as approved by the FDA.

While off-label medications may lead to modest weight loss and improvements in cardiovascular risk factors, they are not effective on their own and often result in weight regain after discontinuation, highlighting the importance of medical supervision and behavior modification in weight loss strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medications as adjunct therapy for weight loss: approved and off-label agents in use. Moyers, SB.[2006]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Identification and counseling for obesity among children on psychotropic medications in ambulatory settings. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Assessment and management of obesity in childhood and adolescence. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Potential Role of Combination Pharmacotherapy to Improve Outcomes of Pediatric Obesity: A Case Report and Discussion. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Trends in pediatric obesity management, a survey from the Pediatric Endocrine Society Obesity Committee. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical Considerations Regarding the Use of Obesity Pharmacotherapy in Adolescents with Obesity. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Pharmacotherapeutic options for overweight adolescents. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Meal replacements followed by topiramate for the treatment of adolescent severe obesity: A pilot randomized controlled trial. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of Obesity: Clinical Trials to Clinical Practice. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Evolution of pharmacological obesity treatments: focus on adverse side-effect profiles. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Clinical review: Guide to pharmacological management in pediatric obesity medicine. [2023]

11. England pubmed.ncbi.nlm.nih.gov

One-year effects of two intensive inpatient treatments for severely obese children and adolescents. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Fundamentals of cardiometabolic risk factor reduction: achieving and maintaining weight loss with pharmacotherapy or bariatric surgery. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Medications as adjunct therapy for weight loss: approved and off-label agents in use. [2006]