title: Exploring the mechanisms of weight loss in the SHED-IT intervention for overweight men: a mediation analysis.
abstract: BACKGROUND
  Statistical mediation analysis can be used to improve the design of obesity prevention and treatment programs by identifying the possible mechanisms through which an intervention achieved its effects. The aim of this study was to identify mediators of weight loss in an Internet-based weight-loss program specifically designed for overweight men.
  
  
  METHODS
  The Self-Help, Exercise and Diet using Information Technology (SHED-IT) program was a 3-month randomized controlled trial (Internet-based intervention group vs information only control group) that was implemented in 2007 with baseline and 6-month follow-up assessment of weight, physical activity and dietary behaviors. Intention-to-treat and per-protocol mediation analyses were conducted using a product-of-coefficients test.
  
  
  RESULTS
  Participants (N = 65) were overweight and obese male academic (n = 10) and non-academic (n = 27) staff and students (n = 28) from the University of Newcastle, Australia. Mean (SD) age = 35.9 (11.1) years and mean (SD) BMI = 30.6 (2.8). In the intention-to-treat analysis, both groups lost weight, but relative to the control group, the intervention did not have a statistically significant 'total effect' on weight, tau = -.507, p = .716 (95% CI = -3.277 to 2.263). In the per-protocol analysis, the intervention had a statistically significant 'total effect' on weight, tau = -4.487, p < .05 (95% CI = -8.208 to -.765). The intervention did not have a statistically significant effect on any of the hypothesized mediators and none of the behavioral variables mediated weight loss in the SHED-IT program. Although participants in the intervention group reduced their fat intake over the study period, the changes did not satisfy the criteria for mediation.
  
  
  CONCLUSIONS
  Few studies have examined the mediators of weight loss in obesity treatment interventions. While none of the hypothesized mediators satisfied the criteria for mediation in the current study, there was some evidence to suggest that overweight men in the SHED-IT intervention reduced their fat intake over the study period. Future obesity treatment and prevention programs should explore behavioral mediators of weight loss using appropriate statistical methods.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry No: ANZCTRN12607000481471.
authors.affiliation: School of Education, Faculty of Education & Arts, University of Newcastle, Australia. David.Lubans@newcastle.edu.au.
authors.forename: David R
authors.initials: DR
authors.lastname: Lubans
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Morgan
authors.forename: Clare E
authors.initials: CE
authors.lastname: Collins
authors.forename: Janet M
authors.initials: JM
authors.lastname: Warren
authors.forename: Robin
authors.initials: R
authors.lastname: Callister