Intensive Behavioral Program Arm for Childhood Obesity

University of Minnesota, Delaware Clinical Research Unit, Minneapolis, MN
Semaglutide and Behavioral Program +1 morePhase 2RecruitingLed by Aaron Kelly, PhDResearch Sponsored by University of Minnesota

Study Summary

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

Eligible Conditions
  • Childhood Obesity


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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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).

Find a site

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,315 Previous Clinical Trials
1,502,173 Total Patients Enrolled
Aaron Kelly, PhDPrincipal Investigator
University of Minnesota
1 Previous Clinical Trials
143 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 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
~17 spots leftby Jan 2024