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BMC Medicine

, 15:46

First Online: 02 March 2017Received: 05 December 2016Accepted: 06 February 2017DOI: 10.1186-s12916-017-0808-6

Cite this article as: Padwal, R.S., Klarenbach, S., Sharma, A.M. et al. BMC Med 2017 15: 46. doi:10.1186-s12916-017-0808-6

Abstract

BackgroundIn 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.

MethodsWe 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.

ResultsAt 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-m and 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.

DiscussionTwo 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.

Trial registrationClinicalTrials.gov, NCT01860131. Registered 17 May 2013.

KeywordsBariatric care Wait list Severe obesity Randomized controlled trial Self-management Electronic supplementary materialThe online version of this article doi:10.1186-s12916-017-0808-6 contains supplementary material, which is available to authorized users.





Author: Raj S. Padwal - Scott Klarenbach - Arya M. Sharma - Miriam Fradette - Susan E. Jelinski - Alun Edwards - Sumit R. Majum

Source: https://link.springer.com/



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