Evidence map›Paper›PMID 38219798›Full record

ArticleContemporary clinical trials2024

SMART use of medications for the treatment of adolescent severe obesity: A sequential multiple assignment randomized trial protocol.

Claudia K Fox, David M Vock, Nancy E Sherwood, Amy C Gross, Justin R Ryder, Megan O Bensignor, Eric M Bomberg, Muna Sunni, Carolyn T Bramante, Nina Jacobs and 2 more

Open access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.8field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 1 country.

Claudia K FoxCenter for Pediatric Obesity Medicine and Department of Pediatrics, University of Minnesota Medical School, United States of America. Electronic address: lusc0001@umn.edu.
David M VockDivision of Biostatistics, School of Public Health, University of Minnesota, United States of America.
Nancy E SherwoodDivision of Epidemiology and Community Health, School of Public Health, University of Minnesota, United States of America.
Amy C GrossCenter for Pediatric Obesity Medicine and Department of Pediatrics, University of Minnesota Medical School, United States of America.
Justin R RyderAnn & Robert H. Lurie Children's Hospital of Chicago, United States of America; Northwestern Feinberg School of Medicine, United States of America.
Megan O BensignorCenter for Pediatric Obesity Medicine and Department of Pediatrics, University of Minnesota Medical School, United States of America.
Eric M BombergCenter for Pediatric Obesity Medicine and Department of Pediatrics, University of Minnesota Medical School, United States of America.
Muna SunniDivision of Pediatric Endocrinology, Department of Pediatrics, University of Minnesota Medical School, United States of America.
Carolyn T BramanteCenter for Pediatric Obesity Medicine and Department of Pediatrics, University of Minnesota Medical School, United States of America.
Nina JacobsCenter for Pediatric Obesity Medicine and Department of Pediatrics, University of Minnesota Medical School, United States of America.
Sarah J RaatzCenter for Pediatric Obesity Medicine and Department of Pediatrics, University of Minnesota Medical School, United States of America.
Aaron S KellyCenter for Pediatric Obesity Medicine and Department of Pediatrics, University of Minnesota Medical School, United States of America.
University of Minnesota Medical Center · USUniversity of Minnesota · USNorthwestern University · US

Funding

SMART Use of Medication for the Treatment ofAdolescent Severe ObesityR01DK119456 · NIDDK · UNIVERSITY OF MINNESOTA · PI FOX, CLAUDIA K · 2019 to 2023
$3.2M
Precision Medicine Approaches to Obesity Pharmacotherapy in Youth with Severe ObesityK23DK125668 · NIDDK · UNIVERSITY OF MINNESOTA · PI BOMBERG, ERIC MORRIS · 2020 to 2024
$1.0M
Anti-obesity pharmacotherapy to decrease BMI and improve insulin sensitivity in adolescents with obesity and type 2 diabetesK23DK129721 · NIDDK · UNIVERSITY OF MINNESOTA · PI BENSIGNOR, MEGAN O · 2021 to 2025
$1.0M
Self-weighing for Weight Management in Adolescents with ObesityK23DK124654 · NIDDK · UNIVERSITY OF MINNESOTA · PI BRAMANTE, CAROLYN T · 2021 to 2024
$801k
NIDDK NIH HHS K23 DK124654NIDDK NIH HHS K23 DK125668NIDDK NIH HHS K23 DK129721NIDDK NIH HHS R01 DK119456
6 · The paper itself

Abstract

backgroundSevere obesity is a complex, chronic disease affecting nearly 9% of adolescents in the U.S. Although the current mainstay of treatment is lifestyle therapy, pediatric clinical practice guidelines recommend the addition of adjunct anti-obesity medication (AOM), such as phentermine and topiramate. However, guidance regarding when adjunct AOM should be started and how AOM should be used is unclear. Furthermore, an inherent limitation of current treatment guidelines is their "one-size-fits-all" approach, which does not account for the heterogeneous nature of obesity and high degree of patient variability in response to all interventions.

methodsThis paper describes the study design and methods of a sequential multiple assignment randomized trial (SMART), "SMART Use of Medications for the Treatment of Adolescent Severe Obesity." The trial will examine 1) when to start AOM (specifically phentermine) in adolescents who are not responding to lifestyle therapy and 2) how to modify AOM when there is a sub-optimal response to the initial pharmacological intervention (specifically, for phentermine non-responders, is it better to add topiramate to phentermine or switch to topiramate monotherapy). Critically, participant characteristics that may differentially affect response to treatment will be assessed and evaluated as potential moderators of intervention efficacy.

conclusionData from this study will be used to inform the development of an adaptive intervention for the treatment of adolescent severe obesity that includes empirically-derived decision rules regarding when and how to use AOM. Future research will test this adaptive intervention against standard "one-size-fits-all" treatments.

Indexed as

Anti-Obesity AgentsObesity, MorbidPediatric ObesityAdolescentChildFructoseHumansPhentermineRandomized Controlled Trials as TopicTopiramateWeight LossAnti-Obesity AgentsFructosePhentermineTopiramateAdolescentLifestyle therapyObesityPhentermineProtocolSMARTTopiramate

Identifiers

PMID38219798
PMCPMC11037878
OpenAlexW4390889411

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.