title: Preventing diabetes in obese Latino youth with prediabetes: a study protocol for a randomized controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  NCT02615353, registered on June 8, 2016.
authors.affiliation: Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, 500 N. 3rd Street, Phoenix, AZ, 85013, USA.
authors.forename: Erica G
authors.initials: EG
authors.lastname: Soltero
authors.affiliation: Family Wellness Program, Virginia G. Piper, St. Vincent de Paul Medical and Dental Clinic, 1730 E. Monroe Street, Phoenix, AZ, 85034, USA.
authors.forename: Yolanda P
authors.initials: YP
authors.lastname: Konopken
authors.affiliation: Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, 500 N. 3rd Street, Phoenix, AZ, 85013, USA.|Division of Endocrinology and Diabetes, Phoenix Children's Hospital, 1919 East Thomas Road, Phoenix, AZ, 85016, USA.
authors.forename: Micah L
authors.initials: ML
authors.lastname: Olson
authors.affiliation: Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, 500 N. 3rd Street, Phoenix, AZ, 85013, USA.
authors.forename: Colleen S
authors.initials: CS
authors.lastname: Keller
authors.affiliation: Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, 500 N. 3rd Street, Phoenix, AZ, 85013, USA.
authors.forename: Felipe G
authors.initials: FG
authors.lastname: Castro
authors.affiliation: Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, 500 N. 3rd Street, Phoenix, AZ, 85013, USA.|Southwest Interdisciplinary Research Center, Arizona State University, 411 N. Central Avenue, Suite 720, Phoenix, AZ, 85004-0693, USA.
authors.forename: Allison N
authors.initials: AN
authors.lastname: Williams
authors.affiliation: Seattle Quality of Life Group, Department of Health Services, School of Public Health and Community Medicine, University of Washington, Seattle, USA.
authors.forename: Donald L
authors.initials: DL
authors.lastname: Patrick
authors.affiliation: Southwest Interdisciplinary Research Center, Arizona State University, 411 N. Central Avenue, Suite 720, Phoenix, AZ, 85004-0693, USA.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Ayers
authors.affiliation: Department of Radiology, Phoenix Children's Hospital, 1919 East Thomas Road, Phoenix, AZ, 85016, USA.
authors.forename: Houchun H
authors.initials: HH
authors.lastname: Hu
authors.affiliation: Valley of the Sun YMCA, 350 N. 1st Avenue, Phoenix, AZ, 85003, USA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Sandoval
authors.affiliation: Division of Endocrinology and Diabetes, Phoenix Children's Hospital, 1919 East Thomas Road, Phoenix, AZ, 85016, USA.
authors.forename: Janiel
authors.initials: J
authors.lastname: Pimentel
authors.affiliation: Diabetes Epidemiology and Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 4212 North 16th Street, Phoenix, AZ, 85016, USA.
authors.forename: William C
authors.initials: WC
authors.lastname: Knowler
authors.affiliation: Johns Hopkins Carey Business School, 100 International Drive, Baltimore, MD, 21202, USA.
authors.forename: Kevin D
authors.initials: KD
authors.lastname: Frick
authors.affiliation: Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, 500 N. 3rd Street, Phoenix, AZ, 85013, USA. Gabriel.Shaibi@asu.edu.|Division of Endocrinology and Diabetes, Phoenix Children's Hospital, 1919 East Thomas Road, Phoenix, AZ, 85016, USA. Gabriel.Shaibi@asu.edu.|Southwest Interdisciplinary Research Center, Arizona State University, 411 N. Central Avenue, Suite 720, Phoenix, AZ, 85004-0693, USA. Gabriel.Shaibi@asu.edu.
authors.forename: Gabriel Q
authors.initials: GQ
authors.lastname: Shaibi
mesh_terms: D000293:Adolescent; D001521:Behavior Therapy / Q000379:methods*; D002985:Clinical Protocols; D065246:Culturally Competent Care / Q000379:methods*; D003924:Diabetes Mellitus, Type 2 / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D000070497:Healthy Lifestyle; D006630:Hispanic or Latino; D006801:Humans; D007333:Insulin Resistance; D008297:Male; D009765:Obesity / Q000150:complications / Q000523:psychology / Q000628:therapy*; D010348:Patient Care Team; D011236:Prediabetic State / Q000150:complications / Q000523:psychology / Q000628:therapy*; D011788:Quality of Life; D012307:Risk Factors; D040242:Risk Reduction Behavior; D016896:Treatment Outcome
keywords: Adolescents; Diabetes prevention; Disparities; Intervention; Latino; Obesity