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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

QUEST Trial Summary

This trial found that pharmacotherapy helped facilitate weight loss in adolescents with severe obesity when used in conjunction with low-intensity behavioral counseling.

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.Check my eligibility

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.See study design

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.

QUEST Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am severely obese according to BMI standards.

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

QUEST Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in body mass index

QUEST 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,380 Previous Clinical Trials

1,588,622 Total Patients Enrolled

Aaron Kelly, PhDPrincipal InvestigatorUniversity of Minnesota

2 Previous Clinical Trials

269 Total Patients Enrolled

Media Library

Intensive Behavioral Program Clinical Trial Eligibility Overview. Trial Name: NCT04873245 — Phase 2

Childhood Obesity Research Study Groups: Intensive Behavioral Program Arm, Medication Arm

Childhood Obesity Clinical Trial 2023: Intensive Behavioral Program Highlights & Side Effects. Trial Name: NCT04873245 — Phase 2

Intensive Behavioral Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04873245 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Intensive Behavioral Program Arm likely to cause serious harm to people?

"While there is some evidence of safety, the lack of efficacy data drops Intensive Behavioral Program Arm's score to a 2."

Answered by AI

Are there any vacancies in this research project for willing test subjects?

"Yes, this trial is still ongoing and looking for participants. It was originally posted on March 15th, 2022 and updated two days ago on the 17th."

Answered by AI

Has this clinical trial been done before?

"Intensive Behavioral Program Arm has been the subject of clinical research trials since 2018. The first study was sponsored by Novo Nordisk A/S and took place in that same year. It involved 1387 patients. After this initial Phase 4 drug approval trial in 2018, there have been 58 active Intensive Behavioral Program Arm trials spread out over 766 cities and 55 countries."

Answered by AI

If a person is under the age of 65, can they participate in this research project?

"The age range that is eligible for this clinical trial according to the inclusion criteria is 12 to 17 years old."

Answered by AI

What population does Intensive Behavioral Program Arm typically target?

"The Intensive Behavioral Program Arm is often used in the treatment of chronic weight management. Additionally, this course of action can be taken to help patients with comorbid conditions that are related to weight, including a reduced-calorie diet and exercise."

Answered by AI

Are there other medical studies that compare the Intensive Behavioral Program Arm to other treatments?

"Currently, there are 58 ongoing trials related to the Intensive Behavioral Program Arm. Most of these studies are in Phase 3 and 27 of them are based in Loma Linda, California. However, clinical trials for this topic are being conducted at 3894 different locations worldwide."

Answered by AI

Which types of patients does this study seek to enroll?

"Candidates between the ages of 12 and 17 who suffer from pediatric obesity have a chance to be a part of this clinical trial. Out of the 120 candidates that will be accepted, researchers are looking for those who fit these specific inclusion criteria."

Answered by AI

How many willing test subjects are needed for this experiment?

"Yes, the information on clinicaltrials.gov says that this trial is actively seeking patients. The study was originally posted on 3/15/2022 and was most recently edited on 3/17/2022. The trial is recruiting for 120 patients across 1 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lifestyle Counseling and Medication for Adolescent Weight Management

2022. "Lifestyle Counseling and Medication for Adolescent Weight Management". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04873245.

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