Lifestyle Counseling and Medication for Adolescent Weight Management

NCT04873245 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: PEDS-2021-29784
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity, Childhood

Outcome Measures

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.

  56 weeks

Study Arms (2)

Intensive Behavioral Program Arm

ACTIVE COMPARATOR

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

Medication Arm

ACTIVE COMPARATOR

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

Intensive Behavioral Program BEHAVIORAL

Participants randomized to this group will receive intensive behavioral therapy.

Intensive Behavioral Program Arm

Semaglutide and Behavioral Program DRUG

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

Medication Arm

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Diabetes (type 1 or 2)
• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota, Delaware Clinical Research Unit

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aaron Kelly, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants who qualify will be randomized to receive either intensive behavioral therapy or treatment with semaglutide plus a less intensive behavioral therapy program.

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: March 15, 2022
• Primary Completion: June 29, 2026
• Study Completion: June 30, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Sharing will be available 10 years after the trial has been concluded.
• Access Criteria: Individuals should contact the study PI for information.

Locations

US (1)