Meena Dasari, PhD, Diego Ayo, MD, Michelle McMacken, MD, Olugbenga Ogedegbe, MD, Manish Parikh, MD. NYU School of Medicine and Bellevue Hospital Center
Introduction: Participation in a medically-supervised weight management (MSWM) program before bariatric surgery is mandated by several insurance payers. However, this requirement is not evidence-based and serves as a barrier to medically necessary treatment. We conducted a pilot randomized trial funded by SAGES to determine the effect of an insurance-mandated MSWM prior to surgery. Our hypotheses are:
(1) There is no difference in BMI between patients who have participated in a medically-supervised weight management program and those who don’t.
(2) MSWM does not change self-reported adherence, physical activity, eating behavior, and health beliefs.
Methods & Procedures: 55 patients were scheduled for laparoscopic adjustable gastric banding (LAGB) and consented to enroll in an ongoing prospective pilot study in a large public hospital. Of these, 12 patients cancelled surgery and 10 patients have been enrolled for less than 6 months. Thus, 33 patients were included in the analysis, with 17 randomized to MSWM (defined as monthly visits over 6 months directed by a physician or nutritionist) and 16 randomized to usual care. Measures of weight, height, adherence, activity level, health beliefs, and eating behavior were obtained at enrollment (ie, baseline) and 6 months after enrollment (ie, MSWM program completion and 2 weeks prior to surgery). For categorical and continuous data, Fisher’s Exact Test and t-test were used to compare groups at the 2 time points before surgery.
Results: Mean age was 45.5 (SD=12.5) years. Majority were female (97%) and non-Caucasian (85%) with an income of less than $20,000 (64%). No significant differences were found between MSWM and usual care for age, gender, ethnicity, education, and income, indicating that the 2 groups were evenly matched for demographic variables. Mean BMI for the MSWM group was 46.3 kg/m² at baseline and 46.0 kg/m² at 6 months. Mean BMI for usual care was 44.7 kg/m² and 44.6 kg/m² (see Table 1). After 6 months of either MSWM or wait and at pre-surgery, no significant differences in BMI or patient behaviors were found between the 2 groups. Preliminary analysis of available 3-month post-operative data (n=13) showed similar mean BMI when comparing MSWM (41.3 kg/m²) and usual care (41.2 kg/m 2).
Conclusion: Our preliminary results indicate that MSWM does not affect BMI changes or patient behaviors prior to or after LAGB surgery.
|Baseline||6 month||Change at pre-surgery||Baseline||6 month||Change at pre-surgery||p|
|BMI||46.3||46.0||-0.3 (1.3)||44.7||44.6||-0.1 (1.4)||0.8*|
|Adherence||1.07||.43||-.64 (1.0)||1.57||1.00||-.57 (1.7)||0.9*|
|Health Beliefs||42.8||44.7||1.9 (4.4)||44.5||44.3||-1.2 (7.2)||0.2*|
|-Hours. of daily activity||.54||.15||-0.38 (0.7)||.64||.11||-.54 (1.4)||0.7*|
Program Number: P075