Pharmacotherapy for Obesity in Children and Adolescents: State of the Science, Research Gaps and Opportunities

Event Details

Meeting Resources

• View the Executive Summary (PDF, 197.09 KB)

Meeting Objectives

The overarching goal of the workshop will be to identify gaps and opportunities to guide research and speed progress in the safe, effective, and equitable use of pharmacotherapy for obesity in children and adolescents. This workshop will convene leading scientific and clinical experts with expertise in obesity pathophysiology, clinical trials of pharmacotherapy, clinical use of medication to treat obesity, precision medicine, implementation science, health equity and disparities, and health economics to discuss the use of pharmacotherapy in children, systemic and individual barriers to treatment, effects on physical and mental health, quality of life and eating behaviors, and cost-effectiveness of therapy. At the end of the workshop, participants will identify gaps and opportunities for future research to guide

1. best practices for the use of pharmacotherapy for pediatric obesity, including prescriber training, timing of initiation, duration of therapy, combination therapies, and lifestyle supports;
2. understanding of contextual factors that influence equitable access and reduce barriers to care; and
3. important and unique aspects of the use of pharmacotherapy for obesity in vulnerable populations, including bias and stigma, communication, development of autonomy, and growth and development.

Such research will inform optimal and equitable medical management of children and adolescents with obesity.

Background

Pediatric obesity is highly prevalent and increasing, with approximately 20% of children and adolescents living with this chronic, progressive, and relapsing disease. Non-Hispanic Black and Hispanic youth and children from families experiencing poverty and/or food insecurity are disproportionately affected. Pediatric obesity has been associated with serious complications and co-morbidities, including type 2 diabetes, non-alcoholic fatty liver disease, dyslipidemia, elevated blood pressure, and mental health problems. The many adverse health consequences of obesity threaten the health of tens of millions of Americans and place great strain on the health care system. More importantly, obesity and sequelae can impair a child’s well-being and quality of life during a critical time for growth and development. Moreover, most children and adolescents with obesity retain their excess adiposity into adulthood. The dose and duration of lifestyle modification therapy needed to meaningfully reduce adiposity in children and adolescents is high, often limiting its feasibility in practice. In addition, most behavioral/lifestyle obesity treatment interventions show only modest favorable changes in average body mass index (BMI), which are not sustained. And although response is mixed, a substantial number of children do not experience meaningful improvement. Since 2020, three anti-obesity medications (AOMs)—Liraglutide, Semaglutide, and Phentermine/Topiramate—have been approved by the U.S. Food and Drug Administration for chronic weight management in children ages 12 years and older with non-syndromic obesity, and trials of new medications in the pediatric population are ongoing, including in young children and preadolescents. The availability of AOMs offers an important adjunct to lifestyle intervention for a substantial number of children and adolescents. Research is needed to address important knowledge gaps to ensure appropriate, effective, safe, equitable, and successful adoption of obesity pharmacotherapy in clinical practice, as well as evaluate the long-term use of pharmacotherapy and its potential adverse effects.

Organizing Committee

Co-Chairs

• Sarah C. Armstrong, M.D.
  Professor of Pediatrics
  Chief, Division of General Pediatrics and Adolescent Health
  Duke University School of Medicine
• Ihuoma Eneli, M.D, M.S.
  Visiting Professor of Pediatrics
  University of Colorado
  Children’s Hospital Colorado
• Aaron S. Kelly, Ph.D.
  Professor of Pediatrics
  Minnesota American Legion and Auxiliary Chair in Children’s Health
  Co-Director, Center for Pediatric Obesity Medicine
  University of Minnesota Medical School

Obesity Action Coalition

• Liz Paul, Patient Advocate

NIDDK

• Miranda Broadney, M.D.
• Mary Evans, Ph.D.
• Barbara Linder, M.D.
• Katrina Loh, M.D.
• Voula Osganian, M.D., Sc.D., M.P.H.
• Ken Wilkins, Ph.D.
• Theresa Woo, Ph.D.
• Sue Yanovski, M.D.

NICHD

• Andrew Bremer, M.D.

NHLBI

• Laurie Donze, Ph.D.
• Charlotte Pratt, Ph.D.

OBSSR

• Deborah Young-Hyman, Ph.D.

Registration Deadline

November 27, 2023

Agenda

November 28, 2023

9:30 a.m.

Registration

Welcome and Introductions

10:00 a.m. - 10:10 a.m.

Welcoming Remarks
Griffin P. Rodgers, M.D., M.A.C.P., Director, National Institute of Diabetes and Digestive and Kidney Diseases

10:10 a.m. - 10:20 a.m.

Introduction, Workshop Goals, and Agenda for Day 1
Voula Osganian, M.D., Sc.D., M.P.H., National Institute of Diabetes and Digestive and Kidney Diseases

10:20 a.m. - 10:35 a.m.

Opening Remarks from Meeting Co-Chairs
Sarah Armstrong, M.D., Duke University School of Medicine
Ihuoma Eneli, M.D., University of Colorado
Aaron Kelly, Ph.D., University of Minnesota Medical School

Session 1: Overview of Treatment for Pediatric Obesity

10:35 a.m. - 10:55 a.m.

Understanding the Whole Child with Obesity and the Adverse Physical, Metabolic, and Psychological Consequences of Childhood Obesity
Ihuoma Eneli, M.D., M.S., University of Colorado

10:55 a.m. - 11:25 a.m.

Parent and Patient Journeys with Obesity and Obesity Care
Faith Anne Heeren, B.A., University of Florida
Liz Paul, Obesity Action Coalition
Shawn Dwyer and Cullen Dwyer, Minneapolis, MN
Barbara Van Eeckhout and Edward Kent, Minneapolis, MN

11:25 a.m. - 11:45 a.m.

The Past, Present, and Future of Pediatric Obesity Care and Overview of AAP Clinical Practice Guidelines
Sarah Hampl, M.D., University of Missouri–Kansas City School of Medicine

11:45 a.m. - 12:00 p.m.

Moderated Discussion
Aaron Kelly, Ph.D., University of Minnesota Medical School

12:00 p.m. - 12:15 p.m.

Break

12:15 p.m. - 12:55 p.m.

Lunch and Lightning Talks
Moderator: Charlotte Pratt, Ph.D., National Heart, Lung, and Blood Institute

Session 2: The Science and Rationale for Pharmacotherapy to Treat Obesity

12:55 p.m. - 1:15 p.m.

Pathophysiology of Obesity and the Rationale for the Use of Pharmacotherapy
Ania Jastreboff, M.D., Ph.D., Yale University School of Medicine

1:15 p.m. - 1:35 p.m.

Approved and Emerging Pharmacotherapies for Non-syndromic Obesity: Clinical Trial Evidence of the Safety, Efficacy, and Tolerability of Anti-obesity Medications
Aaron Kelly, Ph.D., University of Minnesota Medical School

1:35 p.m. - 1:55 p.m.

Approved and Emerging Pharmacotherapies for Children with Obesity Syndromes
Jack Yanovski, M.D., Ph.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health

1:55 p.m. - 2:10 p.m.

Moderated Discussion
Justin Ryder, Ph.D., Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern Feinberg School of Medicine

2:10 p.m. - 2:25 p.m.

Break

Session 3: Use of Evidence-Based Treatments for Pediatric Obesity: When and How Intensively to Intervene? What Factors Determine Response and Non-response?

2:25 p.m. - 2:45 p.m.

Challenges of Implementation of Evidence-based Treatments (including MI, IHBLT, AOMs, WLS) in Clinical Settings
Mona Sharifi, M.D., M.P.H., Yale University School of Medicine

2:45 p.m. - 3:05 p.m.

Clinical Use of Anti-obesity Medications: When to Start, Escalate, Wean Down or Stop, Prospect of Physiological Resetting, Contraindications, and Long-term Safety
Claudia Fox, M.D., M.P.H., University of Minnesota School of Medicine

3:05 p.m. - 3:25 p.m.

Metabolic/Bariatric Surgery and the Role of Pharmacotherapy
Tom Inge, M.D., Ph.D., Northwestern Feinberg School of Medicine

3:25 p.m. - 3:45 p.m.

Mental Health Considerations
Denise Wilfley, Ph.D., Washington University School of Medicine

3:45 p.m. - 4:00 p.m.

Moderated Discussion
Sarah Armstrong, M.D., Duke University School of Medicine

4:00 p.m.

Day 1 Meeting Adjournment

November 29, 2023

9:00 a.m. - 9:05 a.m.

Overview of Day 2 Agenda and Goals
Voula Osganian, M.D., Sc.D., M.P.H., National Institute of Diabetes and Digestive and Kidney Diseases

Session 4: Equity and Access to Care

9:05 a.m. - 9:25 a.m.

Barriers and Inequities to Care: The Impact of Weight Stigma and Bias and Provider and Student Education
Kofi Essel, M.D., M.P.H., Elevance Health

9:25 a.m. - 9:45 a.m.

Improving Access to Care: Insurance Coverage, Role of Telemedicine and Virtual Platforms, and Risks of Using Remote Care Platforms
Valerie O’Hara, D.O., Maine Medical Center

9:45 a.m. - 10:00 a.m.

Moderated Discussion
Fatima Cody Stanford, M.D., M.P.H, M.P.A., M.B.A., Harvard Medical School

10:00 a.m. - 11:15 a.m.

Parent and Patient Panel Discussion
Moderator: Ted Kyle, R.Ph., M.B.A., ConscienHealth

Session 5: Design and Measurement

11:15 a.m. - 11:35 p.m.

Clinical Trial Design Considerations for Pharmacotherapy Trials: Best Practices and Future Considerations
Daniel Hsia, M.D., Pennington Biomedical Research Center

11:35 a.m. - 11:55 a.m.

Choosing Meaningful Outcomes and Measures, Including Outcomes to Assess Success and Harm: BMI and Its Limitations, Eating Behaviors, Co-morbidities, Quality of Life, and Other Patient-reported Outcomes
Sarah Barlow, M.D., University of Texas Southwestern Medical School

11:55 a.m. - 12:15 p.m.

Cost-effectiveness Study Designs
Chin Hur, M.D., M.P.H., Columbia University Medical Center

12:15 p.m. - 12:30 p.m.

Moderated Discussion
Asheley Skinner, Ph.D., Duke University School of Medicine

12:30 p.m.-1:30 pm

Working Lunch: Session Small Group Meetings on Takeaways

1:30 p.m. - 3:00 p.m.

Panel Discussion and Closing Remarks
This will be a group discussion led and facilitated by co-chairs.

3:00 p.m.

Meeting Adjournment

Abstracts

Submission Deadline

October 27, 2023

To encourage attendance from next-generation researchers and to extend the breadth of information available, brief presentations or lightning talks of up to 5 minutes will be held in conjunction with the meeting presentations. Individuals selected should also plan to be available for a poster presentation of their talk at the end of the Day 1 presentations.

Applicants must be Early Stage Investigators (ESIs), including those ESIs who received their first R01 award or a career development award, or doctoral and postdoctoral students working in areas of childhood obesity that are relevant to the topic of the meeting.

A 1-page abstract for the lightning talk is required, along with a cover letter containing a brief justification explaining why the submitter thinks the focus of the presentation would be relevant and how it would contribute to the emphasis of the meeting.

It is anticipated that up to five abstracts will be accepted for lightning talks.

Submitting Abstracts

All abstracts must be submitted via email to Danielle Johnikin at djohnikin@scgcorp.com, of The Scientific Consulting Group, Inc. Abstract submissions should be no longer than 250 words (not including name and affiliation). Download the Abstract Template (DOCX, 24.67 KB).

Formatting Requirements

Please follow the instructions below to format abstracts. (Note: Submissions will not be edited for spelling or grammar and will be accepted “as is.”)

1. The abstract should be an MS Word document, typed and single-spaced using Times New Roman font. Everything but the title should be in normal, 12-point font.
   1. The abstract’s title should be bold, 16-Point, Title Case font and should clearly represent the nature of the investigation.
   2. On the first line after the title, list the authors’ first and last names, degree, affiliation, city, state, and country.
   3. Separate multiple authors with a semicolon; underline the primary author’s name (one primary author per abstract).
   4. Use one blank line between the title and body of the abstract and between paragraphs.
   5. The abstract file name should follow this format: LastNameofprimary author_FirstWordOfTitle (e.g., Zucker Effects).
2. Please ensure that your abstract is the correct length and has 1-inch margins.
3. Use of standard abbreviations is desirable (e.g., BMI), as well as standard symbols for units of measure (e.g., kg, g, mg, mL, L, and %). Place any special or unusual abbreviations in parentheses after the full word or phrase the first time it appears. Use figures to indicate numbers except to begin sentences, in which case, the number should be spelled out. Do not use subheadings (e.g., Methods, Results).
4. Simple tables or graphs may be included; however, they must fit within the designated abstract space of one page.

Acceptance Notification

Applicants will be notified if their abstract has been accepted for a lightning talk by November 1, 2023.