title: Small Changes and Lasting Effects (SCALE) Trial: the formation of a weight loss behavioral intervention using EVOLVE.
abstract: BACKGROUND
  Obesity is a major health problem that disproportionately affects Black and Hispanic adults. This paper presents the rationale and innovative design of a small change eating and physical activity intervention (SC) combined with a positive affect and self-affirmation (PA/SA) intervention versus the SC intervention alone for weight loss.
  
  
  METHODS
  Using a mixed methods translational model (EVOLVE), we designed and tested a SC approach intervention in overweight and/ or obese African American and Hispanic adults. In Phase I, we explored participant's values and beliefs about the small change approach. In Phase II, we tested and refined the intervention and then, in Phase III we conducted a RCT. Participants were randomized to the SC approach with PA/SA intervention vs. a SC approach alone for 12 months. The primary outcome was clinically significant weight loss at 12 months.
  
  
  RESULTS
  Over 4.5 years a total of 574 participants (67 in Phase I, 102 in Phase II and 405 in Phase III) were enrolled. Phase I findings were used to create a workbook based on real life experiences about weight loss and to refine the small change eating strategies. Phase II results shaped the recruitment and retention strategy for the RCT, as well as the final intervention. The RCT results are currently under analysis.
  
  
  CONCLUSIONS
  The present study seeks to determine if a SC approach combined with a PA/SA intervention will result in greater weight loss at 12 months in Black and Hispanic adults compared to a SC approach alone.
authors: Division of Clinical Epidemiology and Evaluative Science Research, Weill Cornell Medical College 338 East 66th Street New York, NY 10065; School of Applied Economics and Management, Cornell University 201 Warren Hall Cornell University, Ithaca, NY 14853-7801. Electronic address: erp2001@med.cornell.edu.
authors: Erica G
authors: EG
authors: Phillips-Caesar
authors: George Washington University, Department of Medicine, Foggy Bottom South Pavilion, 22nd & I Street, NW Washington DC 20037.
authors: Ginger
authors: G
authors: Winston
authors: Division of Clinical Epidemiology and Evaluative Science Research, Weill Cornell Medical College 338 East 66th Street New York, NY 10065; School of Applied Economics and Management, Cornell University 201 Warren Hall Cornell University, Ithaca, NY 14853-7801.
authors: Janey C
authors: JC
authors: Peterson
authors: Department of Human Development, Cornell University G96 Martha Van Rensselaer Hall Ithaca, NY 14853-4401.
authors: Brian
authors: B
authors: Wansink
authors: Division of Nutritional Sciences, Cornell University 405 Savage Hall Cornell University Ithaca, NY 14853-4401.
authors: Carol M
authors: CM
authors: Devine
authors: Lincoln Medical and Mental Health Center for Collaborative Community Research.
authors: Balavanketsh
authors: B
authors: Kanna
authors: Lincoln Medical and Mental Health Center for Collaborative Community Research.
authors: Walid
authors: W
authors: Michelin
authors: Department of Human Development, Cornell University G96 Martha Van Rensselaer Hall Ithaca, NY 14853-4401.
authors: Elaine
authors: E
authors: Wethington
authors: Cornell University Department of Statistical Science 301 Malott Hall Ithaca, NY 14853.
authors: Martin
authors: M
authors: Wells
authors: Division of Clinical Epidemiology and Evaluative Science Research, Weill Cornell Medical College 338 East 66th Street New York, NY 10065; School of Applied Economics and Management, Cornell University 201 Warren Hall Cornell University, Ithaca, NY 14853-7801.
authors: James
authors: J
authors: Hollenberg
authors: Division of Clinical Epidemiology and Evaluative Science Research, Weill Cornell Medical College 338 East 66th Street New York, NY 10065; School of Applied Economics and Management, Cornell University 201 Warren Hall Cornell University, Ithaca, NY 14853-7801.
authors: Mary E
authors: ME
authors: Charlson
mesh_terms: D000328:Adult; D000339:Affect; D001741:Black or African American; D001294:Attitude to Health; D001521:Behavior Therapy / Q000379:methods*; D005247:Feeding Behavior; D005260:Female; D006630:Hispanic or Latino; D006801:Humans; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D009765:Obesity / Q000523:psychology / Q000628:therapy*; D036301:Qualitative Research; D012649:Self Concept; D016896:Treatment Outcome; D061217:Weight Reduction Programs / Q000379:methods*
keywords: eating behaviors; mixed methods; physical activity; randomized controlled trial; small changes; weight loss
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