A Comprehensive Multidisciplinary Remote Intervention Program for Weight Regain after Sleeve Gastrectomy: A Randomized Controlled Trial   

Technical Summary: A Comprehensive Multidisciplinary Remote Intervention Program for Weight Regain after Sleeve Gastrectomy

Problem Statement
Weight regain (WR) following sleeve gastrectomy (SG) is a prevalent and growing clinical challenge, with rates ranging from 49% to 76%. WR is multifactorial but is strongly associated with maladaptive eating and lifestyle behaviors and insufficient long-term follow-up (FU). While metabolic bariatric surgery (MBS) is the most effective treatment for severe obesity, managing WR requires customized interventions. Current literature indicates a lack of specific programs targeting patients who have already experienced significant WR, and remote eHealth interventions remain under-explored in this specific context. The study addresses the need for effective, non-surgical interventions to halt and reverse WR while improving physical and behavioral outcomes.

Methodology
The study was an open-label, parallel, randomized controlled trial (RCT) conducted at a single-center specialized bariatric clinic (Assuta Medical Center).

• Participants: 100 patients (76% women, mean age 49.7 ± 11.6 years) who were ≥2 years post-primary SG with a WR of ≥10% from their nadir weight.
• Intervention Group: Received a 3-month remote multidisciplinary program via the DATOS digital platform. This included:
  • Nutritional: One 40-minute initial and five 20-minute follow-up virtual consultations with a registered dietitian (RD).
  • Sleep: One 30-minute initial and two 15-minute follow-up virtual consultations with a sleep consultant.
  • Physical Activity (PA): One 30-minute initial and two 15-minute follow-up virtual consultations with a PA consultant.
  • Behavioral Support: 12 weekly text messages containing targeted tasks to enhance well-being, selected based on literature review and pilot testing.
• Control Group: Received standard care consisting of a single 40-minute remote RD consultation.
• Data Collection: Assessments were conducted at baseline (T0), post-intervention (T3), and at 3-month (T6) and 6-month (T9) follow-ups.
• Outcomes:
  • Primary: Weight change (kg, BMI, %EWL, %TWL).
  • Secondary: Anthropometrics (waist circumference, body composition via BIA), functionality (handgrip strength, 30-second sit-to-stand), eating behaviors (adherence to guidelines, grazing, binge eating, food intolerance), dietary intake (energy, macronutrients, hydration), lifestyle habits (sleep, PA, multivitamin adherence), and subjective well-being.
• Statistical Analysis: Linear mixed models and generalized linear mixed models were used to assess within- and between-group differences over time, with a significance level of p < 0.05.

Key Results

• Weight Outcomes: Mean weight remained stable throughout the study period in both groups. There were no statistically significant differences in weight change between the intervention and control groups at T3, T6, or T9. However, the intervention group showed a non-significant trend toward higher rates of weight maintenance or loss compared to the control group (e.g., at T9, 67.7% vs. 45.0%, p=0.107).
• Functionality: Both groups demonstrated significant improvements in upper and lower extremity strength over time. Notably, the intervention group showed significantly greater improvement in lower extremity strength (30-second sit-to-stand) compared to the control group (p time*group = 0.036).
• Eating Behaviors:
  • Both groups showed significant improvements in general eating behavior compliance.
  • The intervention group demonstrated significantly greater reductions in grazing behavior compared to the control group (p time*group = 0.001).
  • Improvements in subjective binge eating and food intolerance were observed only within the intervention group, not the control group.
• Dietary Intake: Both groups reduced daily energy intake. The intervention group showed a significantly greater improvement in daily water consumption (p time*group < 0.001). While most participants met the minimum protein target (≥60 g/day), few reached the optimal target (≥1.5 g/IBW).
• Lifestyle Habits: The intervention group showed significantly greater improvements in engaging in any physical activity, aerobic minutes per week, and adherence to anaerobic PA recommendations (≥2 sessions/week) compared to the control group. Adherence to multivitamin intake improved significantly in both groups. No significant changes were observed in sleep duration or quality in either group.
• Well-being: No significant changes were observed in happiness, positive/negative emotions, or meaningfulness scores in either group. However, within the intervention group, weight maintenance or loss was associated with lower negative emotion scores.
• Attrition: A significantly higher proportion of control group participants initiated obesity management medications (OMMs) during the study compared to the intervention group (24.0% vs. 6.0% at T9, p=0.012).

Significance and Claims
The paper claims that a 3-month remote comprehensive multidisciplinary intervention, while not achieving statistically significant weight loss compared to standard care, successfully improved several critical functional, physical activity, and eating-related outcomes. Specifically, the intervention was superior in enhancing lower-limb strength, physical activity engagement, and reducing maladaptive eating behaviors such as grazing.

The authors emphasize that the intervention demonstrated potential efficiency in stopping or reverting WR, as evidenced by the trend toward better weight maintenance in the intervention group. They posit that low-level weight loss or stabilization can still provide clinically meaningful health benefits. The study highlights the importance of incorporating multidisciplinary support (nutrition, sleep, PA) and remote delivery to address the barriers to long-term follow-up.

The paper concludes that while the intervention improved behavioral and functional parameters, further research is required to develop tailored protocols that can effectively impact weight outcomes in this specific population. The authors note that the heterogeneity of the time since surgery and the magnitude of weight regain, along with the high rate of OMM initiation in the control group, may have influenced the weight outcomes. The study advocates for a patient-centered approach that looks beyond the scale to include functionality and behavioral health.