title: Relationship between treatment preference and weight loss in the context of a randomized controlled trial.
abstract: Randomized controlled trials (RCTs) are considered the gold standard used to assess the efficacy of treatment. While a well implemented RCT can produce an unbiased estimate of the relative difference between treatment groups, the generalizability of these findings may be limited. Specific threats to the external validity include treatment preference. The purposes of this study were to: (i) assess whether receiving one's treatment preference was associated with weight loss and retention and (ii) whether receiving one's treatment preference modified the relationship between the treatments and weight loss. Treatment preference was assessed in 250 subjects prior to but independent of randomization into either low-carbohydrate or low-fat diets. Treatment preference was a predictor of weight loss (P = 0.002) but not retention (P = 0.90). Participants who received their preference lost less weight (-7.7 kg, 95% confidence interval (CI): -9.3 to -6.1) than participants who did not receive their preference (-9.7 kg, 95% CI: -11.4 to -8.1) and participants who did not report a strong preference at baseline (-11.2 kg, 95% CI: -12.6 to -9.7) (P = 0.04 and P = 0.0004, respectively). Treatment preference did not modify the effect of the treatment on weight loss. Contrary to conceptual predictions, this study failed to identify an interaction between treatment preference and weight loss in the setting of a randomized trial. Until treatment preference effects are definitively ruled out in this domain, future studies might consider stratifying their randomization procedure by treatment preference rather than excluding participants with strong treatment preferences.
authors.affiliation: Center for Obesity Research and Education, Temple University School of Medicine, Philadelphia, Pennsylvania, USA. kborradaile@mathematica-mpr.com
authors.forename: Kelley E
authors.initials: KE
authors.lastname: Borradaile
authors.forename: Scott D
authors.initials: SD
authors.lastname: Halpern
authors.forename: Holly R
authors.initials: HR
authors.lastname: Wyatt
authors.forename: Samuel
authors.initials: S
authors.lastname: Klein
authors.forename: James O
authors.initials: JO
authors.lastname: Hill
authors.forename: Brooke
authors.initials: B
authors.lastname: Bailer
authors.forename: Carrie
authors.initials: C
authors.lastname: Brill
authors.forename: Richard I
authors.initials: RI
authors.lastname: Stein
authors.forename: Bernard V
authors.initials: BV
authors.lastname: Miller
authors.forename: Gary D
authors.initials: GD
authors.lastname: Foster
mesh_terms: D004038:Diet, Reducing / Q000523:psychology / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000178:diet therapy* / Q000523:psychology; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D015203:Reproducibility of Results; D015431:Weight Loss; D061217:Weight Reduction Programs