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Randomized Controlled Trial
. 2015 Mar:41:118-28.
doi: 10.1016/j.cct.2015.01.003. Epub 2015 Jan 26.

Small Changes and Lasting Effects (SCALE) Trial: the formation of a weight loss behavioral intervention using EVOLVE

Erica G Phillips-Caesar  1 , Ginger Winston  2 , Janey C Peterson  3 , Brian Wansink  4 , Carol M Devine  5 , Balavanketsh Kanna  6 , Walid Michelin  6 , Elaine Wethington  4 , Martin Wells  7 , James Hollenberg  3 , Mary E Charlson  3
Affiliations
Randomized Controlled Trial

Small Changes and Lasting Effects (SCALE) Trial: the formation of a weight loss behavioral intervention using EVOLVE

Erica G Phillips-Caesar et al. Contemp Clin Trials. 2015 Mar.

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.

Conclusion: 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.

Keywords: eating behaviors; mixed methods; physical activity; randomized controlled trial; small changes; weight loss.

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Figures

Figure 1
Figure 1
Flow diagram of pilot study
Figure 2
Figure 2
Flow diagram of randomized control trial design
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