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At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
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BMC Public Health
Published in: BMC Public Health 1/2017

Open Access 01-12-2017 | Study protocol

Preventing diabetes in obese Latino youth with prediabetes: a study protocol for a randomized controlled trial

Authors: Erica G. Soltero, Yolanda P. Konopken, Micah L. Olson, Colleen S. Keller, Felipe G. Castro, Allison N. Williams, Donald L. Patrick, Stephanie Ayers, Houchun H. Hu, Matthew Sandoval, Janiel Pimentel, William C. Knowler, Kevin D. Frick, Gabriel Q. Shaibi

Published in: BMC Public Health | Issue 1/2017

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Abstract

Background

Obese Latino adolescents are disproportionately impacted by insulin resistance and type 2 diabetes. Prediabetes is an intermediate stage in the pathogenesis of type 2 diabetes and represents a critical opportunity for intervention. However, to date, no diabetes prevention studies have been conducted in obese Latino youth with prediabetes, a highly vulnerable and underserved group. Therefore, we propose a randomized-controlled trial to test the short-term (6-month) and long-term (12-month) efficacy of a culturally-grounded, lifestyle intervention, as compared to usual care, for improving glucose tolerance and reducing diabetes risk in 120 obese Latino adolescents with prediabetes.

Methods

Participants will be randomized to a lifestyle intervention or usual care group. Participants in the intervention group will attend weekly nutrition and wellness sessions and physical activity sessions twice a week for six months, followed by three months of booster sessions. The overall approach of the intervention is framed within a multilevel Ecodevelopmental model that leverages community, family, peer, and individual factors during the critical transition period of adolescence. The intervention is also guided by Social Cognitive Theory and employs key behavioral modification strategies to enhance self-efficacy and foster social support for making and sustaining healthy behavior changes. We will test intervention effects on quality of life, explore the potential mediating effects of changes in body composition, total, regional, and organ fat on improving glucose tolerance and increasing insulin sensitivity, and estimate the initial incremental cost effectiveness of the intervention as compared with usual care for improving glucose tolerance.

Discussion

The proposed trial builds upon extant collaborations of a transdisciplinary team of investigators working in concert with local community agencies to address critical gaps in how diabetes prevention interventions for obese Latino youth are developed, implemented and evaluated. This innovative approach is an essential step in the development of scalable, cost-effective, solution oriented programs to prevent type 2 diabetes in this and other populations of high-risk youth.

Trial Registration

NCT02615353, registered on June 8, 2016.
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Metadata
Title
Preventing diabetes in obese Latino youth with prediabetes: a study protocol for a randomized controlled trial
Authors
Erica G. Soltero
Yolanda P. Konopken
Micah L. Olson
Colleen S. Keller
Felipe G. Castro
Allison N. Williams
Donald L. Patrick
Stephanie Ayers
Houchun H. Hu
Matthew Sandoval
Janiel Pimentel
William C. Knowler
Kevin D. Frick
Gabriel Q. Shaibi
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2017
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-017-4174-2

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