title: Evaluation of a culturally-adapted lifestyle intervention to treat elevated cardiometabolic risk of Latino adults in primary care (Vida Sana): A randomized controlled trial.
abstract: Latinos bear a disproportionate burden of the dual pandemic of obesity and diabetes. However, successful interventions addressing this disparity through primary care are lacking. To address this gap, the 5-year Vida Sana (Healthy Life) study tests a culturally adapted and technology-enhanced group-based Diabetes Prevention Program intervention in a randomized controlled trial with overweight/obese Latino adults who have metabolic syndrome and/or pre-diabetes. Eligible, consenting patients (n=186) from a large community-based multispecialty group practice in Northern California will be randomly assigned to receive the culturally-adapted intervention or usual care. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework guided the planned evaluations. The primary aim is to determine the effectiveness of the intervention (the "E" in RE-AIM). We hypothesize that the intervention will lead to a greater mean reduction in weight at 24months (primary endpoint) vs. usual care. Secondary outcomes will include measures of cardiometabolic risk factors (e.g., blood pressure), psychosocial well-being (e.g., health-related quality of life), and behavior change (e.g., physical activity). The secondary aim is to evaluate the other RE-AIM dimensions using mixed methods: reach (e.g., participation rate of the target population), adoption (e.g., participating clinic and provider characteristics), implementation (e.g., intervention fidelity), and maintenance (e.g., sustainability in the practice setting). These findings have real word applicability with value to clinicians, patients, and other decision makers considering effective diabetes prevention programs for primary care that would support the millions of Latino adults who experience a disproportionate burden of diabetes.
  
  
  
  NCT02459691.
authors.affiliation: Palo Alto Medical Foundation Research Institute, 795 El Camino Real, Ames Building, Palo Alto, CA 94301, United States. Electronic address: rosasl@pamfri.org.
authors.forename: Lisa G
authors.initials: LG
authors.lastname: Rosas
authors.affiliation: Palo Alto Medical Foundation Research Institute, 795 El Camino Real, Ames Building, Palo Alto, CA 94301, United States.
authors.forename: Nan
authors.initials: N
authors.lastname: Lv
authors.affiliation: Palo Alto Medical Foundation Research Institute, 795 El Camino Real, Ames Building, Palo Alto, CA 94301, United States.
authors.forename: Lan
authors.initials: L
authors.lastname: Xiao
authors.affiliation: RTI International, 3040 Cornwallis Rd., P.O. Box 12194, Research Triangle Park, NC 27709, United States. Electronic address: melewis@rti.org.
authors.forename: Megan A
authors.initials: MA
authors.lastname: Lewis
authors.affiliation: University of California Santa Cruz, 1156 High Street, Santa Cruz, CA 95064, United States. Electronic address: Zavella@ucsc.edu.
authors.forename: Patricia
authors.initials: P
authors.lastname: Zavella
authors.affiliation: University of Pittsburgh, 3512 Fifth Avenue, Pittsburgh, PA 15213, United States. Electronic address: mkk3@pitt.edu.
authors.forename: M Kaye
authors.initials: MK
authors.lastname: Kramer
authors.affiliation: Palo Alto Medical Foundation Research Institute, 795 El Camino Real, Ames Building, Palo Alto, CA 94301, United States.
authors.forename: Veronica
authors.initials: V
authors.lastname: Luna
authors.affiliation: Palo Alto Medical Foundation Research Institute, 795 El Camino Real, Ames Building, Palo Alto, CA 94301, United States; University of Illinois at Chicago, Chicago, IL 60607, United States. Electronic address: maj2015@uic.edu.
authors.forename: Jun
authors.initials: J
authors.lastname: Ma
mesh_terms: D002140:California; D031204:Caloric Restriction / Q000379:methods; D065246:Culturally Competent Care; D003924:Diabetes Mellitus, Type 2 / Q000517:prevention & control*; D015444:Exercise; D006630:Hispanic or Latino; D006801:Humans; D008019:Life Style; D024821:Metabolic Syndrome / Q000628:therapy*; D011236:Prediabetic State / Q000628:therapy*; D011320:Primary Health Care / Q000379:methods*; D061217:Weight Reduction Programs / Q000379:methods*
keywords: Behavioral intervention; Cultural adaptation; Latinos; Obesity; Primary care; Weight loss