Center-size as a predictor of weight-loss outcome in multicenter trials including a low-calorie diet

Obesity (Silver Spring). 2010 Nov;18(11):2160-4. doi: 10.1038/oby.2010.118. Epub 2010 Jun 10.

Abstract

It has not been studied yet whether factors such as the number of subjects recruited by specialized centers for multicenter trials may influence weight loss during a low-calorie diet (LCD). This study aimed at determining whether the number of recruited subjects per center might predict relative weight loss. This is a post hoc analysis of an existing database: 701 obese subjects (77% women, 23% men, mean BMI: 38.9 kg/m(2)) were enrolled at 22 sites (4-85 subjects/site) in five countries to follow a LCD providing 800-1,000 kcal/day during 8 weeks. The main outcome measure was the percentage weight loss after the 8-week LCD. Mean weight loss differed significantly between participating centers (5.8-11.8% of the initial weight; P < 0.001). There was a significant positive correlation between relative weight loss and the number of recruited subjects per center (r = 0.38; P < 0.001). In a multiple stepwise regression analysis, the number of recruited subjects per center appeared to be the main predictive factor of weight loss (R(2) = 0.07; P < 0.001). As the number of participants within each center is clustered, we applied a hierarchical model to model the average weight loss vs. the number of participants included at each center. This model allows to predict that for 10 extra patients in a center, the average weight loss would increase by 0.5%. This is the first study suggesting that the number of recruited subjects per center may impact weight loss, and could therefore be considered as a new predictor for weight loss that is independent from the individual.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Caloric Restriction*
  • Diet, Reducing*
  • Energy Intake*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Multicenter Studies as Topic* / methods
  • Obesity / diet therapy*
  • Patient Selection
  • Sample Size*
  • Treatment Outcome
  • Weight Loss*