title: The evaluating self-management and educational support in severely obese patients awaiting multidisciplinary bariatric care (EVOLUTION) trial: principal results.
abstract: BACKGROUND
  In Canada, demand for multidisciplinary bariatric (obesity) care far outstrips capacity. Consequently, prolonged wait times exist that contribute to substantial health impairments. A supportive, educational, self-management intervention (with in-person and web-based versions) for patients wait-listed for bariatric care has already been implemented in Northern and Central Alberta, Canada, but its effectiveness is unknown. The objective of this trial is to evaluate the clinical and economic outcomes of two self-management programs of varying intensity that are currently in use.
  
  
  METHODS
  We conducted a pragmatic, prospective, parallel-arm, randomized controlled trial of 651 wait-listed patients from two regional bariatric programs. Patients were randomized to (1) an in-person, group-based intervention (13 sessions; n = 215) or (2) a web-based intervention (13 modules; n = 225) or (3) control group (printed educational materials; n = 211). After randomization, subjects had 3 months to review the content assigned to them (the intervention period) prior to bariatric clinic entry. The primary outcome was the proportion of patients achieving 5% weight loss at 9 months. Intention-to-treat two-way comparisons were performed and adjusted for baseline age, sex, site and body mass index.
  
  
  RESULTS
  At baseline, mean age was 40.4 ± 9.8 years, mean weight was 134.7 ± 25.2 kg, mean body mass index was 47.7 ± 7.0 kg/m2and 83% of participants were female. A total of 463 patients (71%) completed 9 months follow-up. At least 5% weight loss was achieved by 24.2% of those in the in-person strategy, 24.9% for the web-based strategy and 21.3% for controls (adjusted p value = 0.26 for in-person vs. controls, 0.28 for web-based vs. controls, 0.96 for in-person vs. web-based). Absolute and relative (% of baseline) mean weight reductions were 3.7 ± 7.1 kg (2.7 ± 5.4%) for in-person strategy, 2.8 ± 6.7 kg (2.0 ± 4.8%) for web-based and 2.9 ± 8.8 kg (1.9 ± 5.9%) for controls (p > 0.05 for all comparisons). No between-group differences were apparent for any clinical or humanistic secondary outcomes. Total annual costs in Canadian dollars were estimated at $477,000.00 for the in-person strategy, $9456.78 for the web-based strategy and $2270.31 for provision of printed materials.
  
  
  CONCLUSIONS
  Two different self-management interventions were no more effective and were more costly than providing printed education materials to severely obese patients. Our findings underscore the need to develop more potent interventions and the importance of comprehensively evaluating self-management strategies before widespread implementation.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT01860131 . Registered 17 May 2013.
authors.affiliation: Department of Medicine, University of Alberta, Edmonton, Alberta, Canada. rpadwal@ualberta.ca.|Alberta Diabetes Institute, Edmonton, Alberta, Canada. rpadwal@ualberta.ca.|Raj Padwal, 5-134A Clinical Sciences Building, 11350-83rd Ave, Edmonton, Alberta, T6G 2B7, Canada. rpadwal@ualberta.ca.
authors.forename: Raj S
authors.initials: RS
authors.lastname: Padwal
authors.affiliation: Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Scott
authors.initials: S
authors.lastname: Klarenbach
authors.affiliation: Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.|Alberta Diabetes Institute, Edmonton, Alberta, Canada.
authors.forename: Arya M
authors.initials: AM
authors.lastname: Sharma
authors.affiliation: Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Miriam
authors.initials: M
authors.lastname: Fradette
authors.affiliation: Digestive Health Strategic Clinical Network, Alberta Health Services, Calgary, Alberta, Canada.
authors.forename: Susan E
authors.initials: SE
authors.lastname: Jelinski
authors.affiliation: Department of Medicine, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Alun
authors.initials: A
authors.lastname: Edwards
authors.affiliation: Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.|Alberta Diabetes Institute, Edmonton, Alberta, Canada.
authors.forename: Sumit R
authors.initials: SR
authors.lastname: Majumdar
mesh_terms: D000328:Adult; D049088:Bariatrics / Q000191:economics / Q000379:methods*; D002170:Canada; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity; D010353:Patient Education as Topic / Q000191:economics / Q000379:methods*; D011446:Prospective Studies; D012648:Self Care / Q000191:economics / Q000379:methods*
keywords: Bariatric care; Randomized controlled trial; Self-management; Severe obesity; Wait list