Association of run-in periods with weight loss in obesity randomized controlled trials

Academic Article

Abstract

  • Summary: Study-level design characteristics that inform the optimal design of obesity randomized controlled trials (RCTs) have been examined in few studies. A pre-randomization run-in period is one such design element that may influence weight loss. We examined 311 obesity RCTs published between 1 January 2007 and 1 July 2009 that examine d weight loss or weight gain prevention as a primary or secondary end-point. Variables included run-in period, pre-post intervention weight loss, study duration (time), intervention type, percent female and degree of obesity. Linear regression was used to estimate weight loss as a function of (i) run-in (yes/no) and (ii) run-in, time, percent female, body mass index and intervention type. Interaction terms were also examined. Approximately 19% (18.6%) of the studies included a run-in period, with pharmaceutical studies having the highest frequency. Although all intervention types were associated with weight loss (Mean=2.80kg, SD=3.52), the inclusion of a pre-randomization run-in was associated with less weight loss (P=0.0017) compared with studies that did not include a run-in period. However, this association was not consistent across intervention types. Our results imply that in trials primarily targeting weight loss in adults, run-in periods may not be beneficial for improving weight loss outcomes in interventions. © 2013 International Association for the Study of Obesity.
  • Published In

  • Obesity Reviews  Journal
  • Digital Object Identifier (doi)

    Author List

  • Affuso O; Kaiser KA; Carson TL; Ingram KH; Schwiers M; Robertson H; Abbas F; Allison DB
  • Start Page

  • 68
  • End Page

  • 73
  • Volume

  • 15
  • Issue

  • 1