BACKGROUND: Many insurance payors mandate that bariatric surgery candidates undergo a medically supervised weight management (MSWM) program as a prerequisite for surgery. However, there is little evidence to support this requirement. We evaluated in a randomized controlled trial the hypothesis that participation in a MSWM program does not predict outcomes after laparoscopic adjustable gastric banding (LAGB) in a publicly insured population. METHODS: This pilot randomized trial was conducted in a large academic urban public hospital. Patients who met NIH consensus criteria for bariatric surgery and whose insurance did not require a mandatory 6-month MSWM program were randomized to a MSWM program with monthly visits over 6 months (individual or group) or usual care for 6 months and then followed for bariatric surgery outcomes postoperatively. Demographics, weight, and patient behavior scores, including patient adherence, eating behavior, patient activation, and physical activity, were collected at baseline and at 6 months (immediately preoperatively and postoperatively). RESULTS:A total of 55 patients were enrolled in the study with complete follow-up on 23 patients. Participants randomized to a MSWM program attended an average of 2 sessions preoperatively. The majority of participants were female and non-Caucasian, mean age was 46 years, average income was less than $20,000/year, and most had Medicaid as their primary insurer, consistent with the demographics of the hospital's bariatric surgery program. Data analysis included both intention-to-treat and completers' analyses. No significant differences in weight loss and most patient behaviors were found between the two groups postoperatively, suggesting that participation in a MSWM program did not improve weight loss outcomes for LAGB. Participation in a MSWM program did appear to have a positive effect on physical activity postoperatively. CONCLUSION:MSWM does not appear to confer additional benefit as compared to the standard preoperative bariatric surgery protocol in terms of weight loss and most behavioral outcomes after LAGB in our patient population.
RCT Entities:
BACKGROUND: Many insurance payors mandate that bariatric surgery candidates undergo a medically supervised weight management (MSWM) program as a prerequisite for surgery. However, there is little evidence to support this requirement. We evaluated in a randomized controlled trial the hypothesis that participation in a MSWM program does not predict outcomes after laparoscopic adjustable gastric banding (LAGB) in a publicly insured population. METHODS: This pilot randomized trial was conducted in a large academic urban public hospital. Patients who met NIH consensus criteria for bariatric surgery and whose insurance did not require a mandatory 6-month MSWM program were randomized to a MSWM program with monthly visits over 6 months (individual or group) or usual care for 6 months and then followed for bariatric surgery outcomes postoperatively. Demographics, weight, and patient behavior scores, including patient adherence, eating behavior, patient activation, and physical activity, were collected at baseline and at 6 months (immediately preoperatively and postoperatively). RESULTS: A total of 55 patients were enrolled in the study with complete follow-up on 23 patients. Participants randomized to a MSWM program attended an average of 2 sessions preoperatively. The majority of participants were female and non-Caucasian, mean age was 46 years, average income was less than $20,000/year, and most had Medicaid as their primary insurer, consistent with the demographics of the hospital's bariatric surgery program. Data analysis included both intention-to-treat and completers' analyses. No significant differences in weight loss and most patient behaviors were found between the two groups postoperatively, suggesting that participation in a MSWM program did not improve weight loss outcomes for LAGB. Participation in a MSWM program did appear to have a positive effect on physical activity postoperatively. CONCLUSION: MSWM does not appear to confer additional benefit as compared to the standard preoperative bariatric surgery protocol in terms of weight loss and most behavioral outcomes after LAGB in our patient population.
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