This grant application seeks funds to perform a randomized controlled trial testing the effectiveness of two guided-self-help treatments for obese patients who experience loss of control over eating (LOC) following gastric bypass surgery. The goal is to identify low-cost and easy-to-disseminate behavioral methods for improving longer-term bariatric surgery outcomes. Although bariatric surgery produces substantial weight losses and improvements in medical co-morbidities in many patients, outcome studies have found that weight regain begins to occur as early as one year postoperatively. Research has also documented improvements in eating behaviors and functioning following bariatric surgery although longer-term studies have reported considerable heterogeneity in these outcomes. Disordered eating behaviors are common following bariatric surgery. Given concerns about heterogeneity of weight loss and psychosocial outcomes following bariatric surgery, research has attempted to identify predictors of outcomes. Although disordered eating behaviors prior to surgery (and many other patient predictors) have not shown negative prognostic significance, LOC post- surgery has been found to reliably predict poorer weight loss and functioning. LOC can be reliably assessed in bariatric patients with existing methods and LOC has been shown, among obese patients, to be highly responsive to cognitive behavioral therapy (CBT) including guided self-help (gshCBT) methods that are cost- effective and can be disseminated to surgery programs. In this study, N=120 gastric bypass patients who experience LOC regularly following surgery will be randomized to one of two experimental conditions (gshCBT or gshBWL (i.e., behavioral weight loss)) or to a standard-of-care (SOC) comparison condition. Assessment of LOC and randomization to treatment will be at 6-months post-surgery. Treatments will be delivered via guided-self-help over three months by allied health clinicians to increase generalizability to bariatric surgery settings and because there exists support for their effective dissemination by non-specialist clinicians. Changes through the course of treatments will be evaluated and major outcome assessments will be conducted by independent evaluators at baseline (6 months post-surgery), post-treatment (9 months post-surgery), and at repeated follow-up assessments every six- months through 24 months after completing treatments (33 months post-surgery). Comprehensive evaluations will assess weight maintenance, LOC, eating behaviors, and associated outcomes (behavioral and psychosocial functioning). Planned analyses will test the effectiveness of gshCBT and gshBWL relative to the standard-of-care comparison condition and relative to each other for reducing LOC eating and enhancing longer-term post-surgical weight maintenance and psychosocial outcomes. Exploratory analyses will test potential predictors, moderators, and mediators of outcomes and provide estimates of cost-effectiveness.

Public Health Relevance

Although bariatric surgery produces substantial weight losses and improvements in medical co-morbidities in a substantial majority of patients, weight re-gain begins to occur as early as one year postoperatively and many patients experience difficulties with loss of control over eating. This study will compare two experimental behavioral treatments delivered post-surgery to each other and to standard-of-care treatment for reducing eating problems and enhancing longer-term weight-loss maintenance and psychosocial functioning. This study has significance for contributing to findings regarding and easy-to-disseminate behavioral interventions for improving longer-term bariatric surgery outcomes.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project (R01)
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Psychosocial Risk and Disease Prevention Study Section (PRDP)
Program Officer
Kuczmarski, Robert J
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Yale University
Schools of Medicine
New Haven
United States
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Wiedemann, Ashley A; Ivezaj, Valentina; Grilo, Carlos M (2018) An examination of emotional and loss-of-control eating after sleeve gastrectomy surgery. Eat Behav 31:48-52
Ivezaj, Valentina; Barnes, Rachel D; Cooper, Zafra et al. (2018) Loss-of-control eating after bariatric/sleeve gastrectomy surgery: Similar to binge-eating disorder despite differences in quantities. Gen Hosp Psychiatry 54:25-30
Ivezaj, V; Grilo, C M (2018) The complexity of body image following bariatric surgery: a systematic review of the literature. Obes Rev 19:1116-1140
Ivezaj, Valentina; Kessler, Erin E; Lydecker, Janet A et al. (2017) Loss-of-control eating following sleeve gastrectomy surgery. Surg Obes Relat Dis 13:392-398
Ivezaj, V; Wiedemann, A A; Grilo, C M (2017) Food addiction and bariatric surgery: a systematic review of the literature. Obes Rev 18:1386-1397
Ivezaj, Valentina; Grilo, Carlos M (2017) Accuracy of Self-Reported Height and Weight Among Sleeve Gastrectomy Patients with Disordered Eating. Obes Surg 27:267-270
Ivezaj, Valentina; Barnes, Rachel D; Grilo, Carlos M (2016) Validity and Clinical Utility of Subtyping by the Beck Depression Inventory in Women Seeking Gastric Bypass Surgery. Obes Surg 26:2068-2073
Ivezaj, Valentina; Grilo, Carlos M (2015) When mood worsens after gastric bypass surgery: characterization of bariatric patients with increases in depressive symptoms following surgery. Obes Surg 25:423-9
White, Marney A; Kalarchian, Melissa A; Levine, Michele D et al. (2015) Prognostic Significance of Depressive Symptoms on Weight Loss and Psychosocial Outcomes Following Gastric Bypass Surgery: A Prospective 24-Month Follow-Up Study. Obes Surg 25:1909-16