Bellevue Center for Obesity and Weight Management, Bellevue Hospital Center, Department of Surgery, New York University School of Medicine, New Bellevue 15 South 7, 550 First Avenue, New York, NY 10016, USA.
Surg Endosc. 2012 Mar;26(3):853-61. doi: 10.1007/s00464-011-1966-9. Epub 2011 Oct 20.
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.
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).
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.
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.
许多保险公司要求接受减重手术的患者参加医学监督下的体重管理（MSWM）计划，作为手术的前提条件。然而，几乎没有证据支持这一要求。我们在一项随机对照试验中评估了一个假设，即在公共保险人群中，参加 MSWM 计划并不能预测腹腔镜可调胃束带术（LAGB）后的结果。
这项试点随机试验在一家大型学术性城市公立医院进行。符合 NIH 减重手术共识标准且其保险不要求强制性 6 个月 MSWM 计划的患者被随机分配至 MSWM 计划组，该组在 6 个月内每月接受一次访视（个体或小组），或在 6 个月内接受常规护理，然后接受减重手术术后结果的随访。收集基线和 6 个月时（术前即刻和术后）的人口统计学数据、体重和患者行为评分，包括患者依从性、饮食行为、患者激活和身体活动。
共有 55 名患者入组研究，其中 23 名患者完成了随访。随机分配至 MSWM 计划组的患者在术前平均参加了 2 次会议。大多数参与者为女性和非白种人，平均年龄为 46 岁，平均收入低于 20,000 美元/年，大多数人主要保险为医疗补助，与医院减重手术项目的人口统计学相符。数据分析包括意向治疗分析和完成者分析。两组术后体重减轻和大多数患者行为均无显著差异，提示参加 MSWM 计划并不能改善 LAGB 的减重效果。参加 MSWM 计划似乎对术后身体活动有积极影响。
在我们的患者人群中，与 LAGB 术前标准减重手术方案相比，MSWM 似乎在体重减轻和大多数行为结果方面没有额外的益处。
