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CompletedNCT04873245QUESTUpdated Jul 2, 2026

Lifestyle Counseling and Medication for Adolescent Weight Management

A Phase 2 interventional study of Intensive Behavioral Program and Semaglutide and Behavioral Program in Obesity, Childhood, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by University of Minnesota · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Study summary

The prevalence of adolescent severe obesity is at an all-time high in the United States and the refractory nature of this disease has led to a serious and challenging conundrum in terms of how to provide effective, safe, scalable, and durable treatments without placing undue strain on the healthcare system. Clinical practice guidelines recommend behavioral interventions as the primary strategy for all ages and classes of obesity - moderate to severe. In 2017, the U.S. Preventive Services Task Force (USPSTF) released updated screening recommendations concluding that comprehensive, intensive behavioral interventions with a total of ≥26 contact hours over a period of 2-12 months resulted in weight loss in youth with obesity, with ≥52 contact hours leading to even greater weight loss and improvements in some cardiometabolic risk factors.

However, the practicality of delivering these types of intensive behavioral services to the millions of youth with severe obesity in the U.S. is debatable not only because of the treatment-resistant nature of severe obesity, but also due to the time-commitment, acceptability, and sustainability of this approach for adolescent patients and their families along with the extensive resources required to provide these interventions. Indeed, fewer than 50% of pediatric patients referred for weight management services enroll in treatment, and high attrition rates of up to 50% have been reported in behavioral-based clinical trials and in the clinical setting. Moreover, adherence to behavioral counseling significantly diminishes over time, which too often erodes early weight loss success and ultimately derails durability. The reality of what most patients/families are able to do and the unique physiological and psychosocial features of severe obesity in adolescence do not seem to align well with the degree of intensity of behavioral interventions shown to be effective by the USPSTF. Therefore, a critical appraisal of the feasibility, effectiveness, and sustainability of the USPSTF recommendations among adolescents with severe obesity is warranted.

While behavior change is an indispensable component of any effective weight loss approach, adjunctive strategies such as pharmacotherapy may enhance outcomes in adolescents with severe obesity. Many maladaptive behaviors attributed to obesity are driven by underlying biological forces, such as increased appetite and food palatability, that are largely beyond the control of the individual. Pharmacotherapy can help facilitate behavior change by disrupting core pathophysiological processes and restoring homeostasis to the energy regulatory system, therein enabling individuals to sustain healthy behavior change. Though under-explored as a treatment for adolescent obesity, pharmacotherapy along with relatively low-intensity behavioral counseling (\<26 contact hours) represents a potentially effective, durable, and safe treatment strategy. This approach may be more practical and feasible to implement on a broad scale, be preferred by patients/families, utilize fewer healthcare resources, and cost less to deliver compared to comprehensive, intensive behavioral interventions.

Read the detailed description

This is a two-arm, randomized clinical trial in adolescents with severe obesity evaluating 52 weeks of intensive behavioral counseling, aligned with USPSTF recommendations (52 contact hours), vs. 52 weeks of medical management with semaglutide (glucagon-like peptide-1 receptor agonist) plus relatively low-intensity behavioral counseling (12 contact hours).

02

Conditions studied

  • Obesity, Childhood

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03

In context

Pediatric Obesity

1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.

This study's enrollment of 120 is above the median of 103 across 862 interventional studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Obesity (Body Mass Index (BMI) >/= 95th percentile or BMI >/= 30 kg/m2)
  • Age 12 to \< 18 years old and Tanner stage >1

Exclusion criteria

Exclusion Criteria:

  • Diabetes (type 1 or 2)
  • Current or recent (\< 6 months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, phentermine, topiramate, combination phentermine/topiramate, liraglutide (or other GLP-1RA) and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion)
  • Previous bariatric surgery
  • Any history of treatment with growth hormone
  • Medically-documented history of bulimia nervosa
  • Any history of schizophrenia, psychosis, mania, chemical dependency
  • Unstable depression requiring hospitalization within the previous 6 month
  • Any history of suicide attempt
  • History of suicidal ideation or self-harm within the previous 30 days as determined at screening by a PHQ-9 score >/= 15 or Suicidal ideation of type 4 or 5 on the C-SSRS
  • Current pregnancy or plans to become pregnant
  • ALT or AST >/= 5 times the upper limit of normal
  • Creatinine > 1.2 mg/dL
  • Uncontrolled hypertension as determined by the local medical monitor
  • Diagnosed and medically-documented monogenic obesity
  • Medically-documented history of cholelithiasis
  • Untreated thyroid disorder
  • Medically documented history of pancreatitis
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
  • Clinically significant heart disease as determined by the local medical monitor
  • Personal history of malignant neoplasms within the past five years
  • Hypersensitivity to any component of semaglutide
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Intensive Behavioral Program Arm

    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).

    Behavioral: Intensive Behavioral Program

  • Active comparator
    Medication Arm

    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).

    Drug: Semaglutide and Behavioral Program

Interventions

  • BehavioralIntensive Behavioral Program

    Participants randomized to this group will receive intensive behavioral therapy.

  • DrugSemaglutide and Behavioral Program

    Participants randomized to this group will receive semaglutide and behavioral therapy.

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What researchers measure

Primary outcomes

  1. Change in body mass index

    The percent change in body mass index (BMI) from Baseline to Week 56 will be calculated. BMI is defined as a person's weight in kilograms divided by the square of height in meters.

    Time frame: 56 weeks

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Study locations

1 site
  • University of Minnesota, Delaware Clinical Research Unit
    Minneapolis, Minnesota 55414, United States
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References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 12, 2025
  • Informed consent form · Feb 12, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — To be determined

Supporting information: Study protocol, Sap, Csr

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04873245
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
May 5, 2021
Start date
Mar 15, 2022
Primary completion
Jun 29, 2026
Completion
Jun 30, 2026
Last update
Jul 2, 2026

Study contacts

Aaron Kelly, PhD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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