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A 2.5-Year Weight Management Program Using Noom Health: Protocol for a Randomized Controlled Trial.
Sysko, R, Bibeau, J, Boyar, A, Costello, K, Michaelides, A, Mitchell, ES, Susanin, A, Hildebrandt, T
JMIR research protocols. 2022;(8):e37541
Abstract
BACKGROUND Overweight and obesity are serious public health concerns. As the prevalence of excess weight among individuals continues to increase, there is a parallel need for inexpensive, highly accessible, and evidence-based weight loss programs. OBJECTIVE This weight loss trial will aim to examine the efficacy of the Noom weight loss program in comparison to a digital control after a 6-month intervention phase and a 24-month maintenance phase, with assessments continuing for 2 years beyond the intervention (to 30 months-after the baseline). The secondary outcomes include quality of life, psychosocial functioning, sleep quality, physical activity, diet, and health status. This trial will also examine the severity of obesity-related functional impairment, weight loss history, and demographic moderators, along with adherence and self-efficacy as mediators of the outcome. METHODS A total of 600 participants were randomized in a parallel-group, controlled trial to either Noom Healthy Weight Program (intervention) or Noom Healthy Weight Control (control) for a 6-month intervention. Both intervention and control groups include diet and exercise recommendations, educational content, daily logging capabilities, and daily weigh-in entries. The Noom Healthy Weight Program also includes a coach support for weight loss. Remote follow-up assessments of eating, physical activity, psychosocial factors, app use data, and weight will be conducted at 1, 4, 6, 12, 18, 24, and 30 months after baseline. Weight is measured at each follow-up point during a Zoom call using the participants' scales. RESULTS Enrollment began in March 2021 and the 6-month intervention phase ended in March 2022. Data collection for the final assessment will be completed in March 2024. CONCLUSIONS This study tests commercially available digital lifestyle interventions for individuals with overweight and obesity seeking weight loss support. Data obtained from the study will evaluate whether the Noom Healthy Weight Control Program can help individuals overcome weight loss, achieve long-term maintenance, adhere to lifestyle changes, and feature use barriers that are present in other traditional weight loss treatments. TRIAL REGISTRATION ClinicalTrials.gov NCT04797169; https://clinicaltrials.gov/ct2/show/NCT04797169. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37541.
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An Initial Test of the Efficacy of a Digital Health Intervention for Bariatric Surgery Candidates.
Sysko, R, Michaelides, A, Costello, K, Herron, DM, Hildebrandt, T
Obesity surgery. 2022;(11):3641-3649
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BACKGROUND Rigorous research on smartphone apps for individuals pursuing bariatric surgery is limited. A digital health intervention was recently developed using standard behavioral weight loss programs with specific modifications for bariatric surgery. The current study evaluated this intervention for improving diet, exercise, and psychosocial health over 8 weeks prior to surgery in an academic medical center. METHODS Fifty patients were randomized to receive either the digital intervention or treatment as usual prior to a surgical procedure. Measures of anxiety, depression, stress, quality of life, physical activity, and diet were administered at baseline and at 8-week follow-up. Statistical power of 80% estimated for N = 50 to detect ES = 0.68 with alpha = 0.05. RESULTS Results of intent-to-treat (N = 50 baseline, N = 36 follow-up) analyses indicated significant moderate differences in stress and anxiety (ES = - 0.58 to - 0.62) favoring the digital intervention. Effects of the program on total daily calories consumed, body mass index, quality of life, and eating disorder symptoms were small (ES = - 0.24 to 0.33) and not significant. Given small effects for these domains, the sample size of the study likely affected the ability to detect significant differences. CONCLUSIONS The digital health intervention appears to significantly impact several measures of physical activity and emotional functioning in candidates for bariatric surgery, which could augment surgical outcomes.
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Randomized Controlled Trial Comparing Health Coach-Delivered Smartphone-Guided Self-Help With Standard Care for Adults With Binge Eating.
Hildebrandt, T, Michaeledes, A, Mayhew, M, Greif, R, Sysko, R, Toro-Ramos, T, DeBar, L
The American journal of psychiatry. 2020;(2):134-142
Abstract
OBJECTIVE Cognitive-behavioral therapy (CBT) has shown efficacy in the treatment of eating disorders. The authors conducted a randomized controlled telemedicine trial of CBT-guided self-help (CBT-GSH) assisted with a smartphone app, Noom Monitor, for binge eating with or without purging. They hypothesized that coach-delivered CBT-GSH telemedicine sessions plus Noom Monitor would yield greater reductions in symptoms of binge eating, purging, and eating disorders compared with standard care. METHODS Fifty-two-week outcomes for CBT-GSH plus Noom Monitor (N=114) were compared with outcomes for standard care (N=111) among members of an integrated health care system in the Pacific Northwest. Patients in the health system who met inclusion criteria were ≥18 years old, had a body mass index ≥18.5, met criteria for DSM-5 binge eating disorder or bulimia nervosa, had 12 months of continuous health care enrollment in Kaiser Permanente Northwest, and had a personal smartphone. Participants received eight CBT-GSH telemedicine sessions over 12 weeks administered by health coaches, and outcomes were assessed at baseline and at weeks 4, 8, 12, 26, and 52. The use of available treatment offered within the Kaiser Permanente health care system was permitted for participants assigned to standard care. RESULTS Participants who received CBT-GSH plus Noom Monitor reported significant reductions in objective binge-eating days (β=-0.66, 95% CI=-1.06, -0.25; Cohen's d=-1.46, 95% CI=-4.63, -1.09) and achieved higher rates of remission (56.7% compared with 30%; number needed to treat=3.74) at 52 weeks compared with participants in standard care, none of whom received any eating disorder treatment during the intervention period (baseline and weeks 1-12). Similar patterns emerged for compensatory behaviors (vomiting, use of laxatives, and excessive exercise; 76.3% compared with 56.8%; number needed to treat=5.11), eating disorder symptoms (body shape, weight, eating concerns, and dietary restraint), and clinical impairment (Cohen's d=-10.07, -2.15). CONCLUSIONS These results suggest that CBT-GSH plus Noom Monitor delivered via telemedicine by routine-practice health coaches in a nonacademic health care system yields reductions in symptoms and impairment over 52 weeks compared with standard care.
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Adolescent Gastric Banding: a 5-Year Longitudinal Study.
Zitsman, JL, DiGiorgi, MF, Zhang, AZ, Kopchinski, JS, Sysko, R, Devlin, MJ, Fennoy, I
Obesity surgery. 2020;(3):828-836
Abstract
BACKGROUND Laparoscopic adjustable gastric banding (LAGB) is used to treat obesity in adults. Less is known about long-term results of the procedure in adolescents. OBJECTIVES To evaluate LAGB 5-year outcomes in teenagers with severe obesity. SETTING Children's hospital, USA. METHODS Adolescents (14-18 years) underwent LAGB in an FDA-approved observational clinical trial. Outcomes including anthropometric measurements, comorbid conditions, complications, and band retention were collected through 60 months. RESULTS One hundred thirty-seven subjects underwent LAGB (94 female, 43 male; 43% white, 37% Hispanic, 17% black; 4% other). Mean age and body mass index (BMI) pre-operatively were 17.0 + 1.2 years and 48.3 + 8.2 kg/m2, respectively. Comorbidities were present in 71%. Maximum weight loss occurred by 36 months (mean % excess weight loss (EWL) 40.6 + 35.2, mean % excess BMI loss (EBMIL) 41.6 + 34.9) and was maintained through 5 years for most subjects. There were no significant differences in weight loss by gender. Twenty-three (18%) of 127 adolescents reporting at 60 months achieved 50% excess weight loss. Postoperative heartburn and emesis occurred in 70% and 32%, respectively. Complications requiring additional surgery occurred 80 times in 63 patients. Thirty-three (26%) of 127 subjects contacted at 5 years had undergone band removal. CONCLUSION In this study, fewer than 20% of adolescents with severe obesity lost > 50% of their excess weight following LAGB. Nearly 50% of patients required additional surgery. With reports of success following sleeve gastrectomy and gastric bypass, we believe that LAGB is not a preferred choice to treat adolescents with obesity.
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Mental health, loss of control eating, and cognitive functioning in adolescents undergoing bariatric surgery.
Reddy, SD, Sysko, R, Mackey, ER
Seminars in pediatric surgery. 2020;(1):150892
Abstract
Bariatric surgery is an effective treatment for severe obesity in adolescence. Nevertheless, much remains to be understood regarding the impact of surgery on mental health, eating behaviors, and cognition. We review the findings related to mental health both before and after surgery as well as long-term changes in psychopathology, including suicide risk. Overall, adolescents with and without a history of psychopathology lose weight at similar rates. At the same time, there is an increased risk for suicide that requires further study. Regarding alcohol and substance use, this population reports lower rates of consumption than age related non-obese cohorts. Nevertheless the impact of altered anatomy and metabolism on alcohol ingestion in a population at risk for substance use is concerning. Eating behaviors, specifically loss of control eating, are discussed. Finally, we include discussion of the cognitive changes occurring perioperatively and considerations for adolescents with cognitive impairments. Clinical recommendations and suggestions for future research are discussed.
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Rigor and reproducibility via laboratory studies of eating behavior: A focused update and conceptual review.
Sysko, R, Steinglass, J, Schebendach, J, Mayer, LES, Walsh, BT
The International journal of eating disorders. 2018;(7):608-616
Abstract
OBJECTIVE The eating behavior of individuals with eating disorders has been examined in laboratory settings over the last 30 years. In this focused review, we build on prior research and highlight several feeding laboratory paradigms that have successfully demonstrated quantifiable and observable behavioral disturbances, and thereby add rigor and reproducibility to the examination of disturbances of eating behavior. This review describes the measures commonly obtained via these laboratory techniques. Supporting Information Appendices with detailed information about implementation are provided to allow for the reproducible execution of these techniques across labs. METHODS/RESULTS Literature documenting the existence of objective abnormalities in eating behavior among individuals with eating disorders or in comparison to healthy controls (n > 40) is briefly summarized. These protocols, conducted across at least 17 independent labs, are sensitive and reproducible, can be used to assess subjective and physiological parameters associated with eating, and elucidate the impact of treatment. Laboratory studies from patients with eating disorders compared with healthy controls reproducibly demonstrate both that patients with Anorexia Nervosa ingest fewer calories and that individuals with Bulimia Nervosa and Binge-Eating Disorder ingest more calories when asked to binge-eat. DISCUSSION Feeding laboratory studies have the potential for quantifying the characteristic behavioral psychopathology of patients with eating disorders, and may provide a useful tool to explore the potential utility of new treatments for individuals with Anorexia Nervosa, Bulimia Nervosa, and Binge-Eating Disorder.
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Randomized controlled trial comparing smartphone assisted versus traditional guided self-help for adults with binge eating.
Hildebrandt, T, Michaelides, A, Mackinnon, D, Greif, R, DeBar, L, Sysko, R
The International journal of eating disorders. 2017;50(11):1313-1322
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Mobile technology offers the potential for greater accessibility to patients, and a reduced treatment burden, which could increase adherence to self-help treatments. The aim of this randomised controlled study was to test the efficacy of a smartphone app – Noom Monitor - compared to traditional cognitive behaviour therapy in the management of binge eating episodes. The study recruited 66 adults who were randomized into two groups: cognitive-behaviour therapy through self-guided help or cognitive-behaviour therapy through self-guided help using Noom Monitor. Results show that patients receiving cognitive-behaviour therapy through self-guided help using Noom Monitor experienced a greater reduction in objective bulimic episodes and purging, and an increase in weekly meal and snack adherence. Authors conclude that smartphone apps can improve initial outcomes of cognitive-behaviour therapy through self-guided help and may offer a useful way to improve participant adherence among those who stay engaged in the treatment.
Abstract
OBJECTIVE Guided self-help treatments based on cognitive-behavior therapy (CBT-GSH) are efficacious for binge eating. With limited availability of CBT-GSH in the community, mobile technology offers a means to increase use of these interventions. The purpose of this study was to test the initial efficacy of Noom Monitor, a smartphone application designed to facilitate CBT-GSH (CBT-GSH + Noom), on study retention, adherence, and eating disorder symptoms compared to traditional CBT-GSH. METHOD Sixty-six men and women with DSM-5 binge-eating disorder (BED) or bulimia nervosa (BN) were randomized to receive eight sessions of CBT-GSH + Noom (n = 33) or CBT-GSH (n = 33) over 12 weeks. Primary symptom outcomes were eating disorder examination objective bulimic episodes (OBEs), subjective bulimic episodes (SBEs), and compensatory behaviors. Assessments were collected at 0, 4, 8, 12, 24, and 36 weeks. Behavioral outcomes were modeled using zero-inflated negative-binomial latent growth curve models with intent-to-treat. RESULTS There was a significant effect of treatment on change in OBEs (β = -0.84, 95% CI = -1.49, -0.19) favoring CBT-GSH + Noom. Remission rates were not statistically different between treatments for OBEs (βlogit = -0.73, 95% CI = -1.86, 3.27; CBT-GSH-Noom = 17/27, 63.0% vs. CBT-GSH 11/27, 40.7%, NNT = 4.5), but CBT-GSH-Noom participants reported greater meal and snack adherence and regular meal adherence mediated treatment effects on OBEs. The treatments did not differ at the 6-month follow-up. DISCUSSION Smartphone applications for the treatment binge eating appear to have advantages for adherence, a critical component of treatment dissemination.
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Heterogeneity moderates treatment response among patients with binge eating disorder.
Sysko, R, Hildebrandt, T, Wilson, GT, Wilfley, DE, Agras, WS
Journal of consulting and clinical psychology. 2010;(5):681-90
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OBJECTIVE The purpose of the study was to explore heterogeneity and differential treatment outcome among a sample of patients with binge eating disorder (BED). METHOD A latent class analysis was conducted with 205 treatment-seeking, overweight or obese individuals with BED randomized to interpersonal psychotherapy (IPT), behavioral weight loss (BWL), or guided self-help based on cognitive behavioral therapy (CBTgsh). A latent transition analysis tested the predictive validity of the latent class analysis model. RESULTS A 4-class model yielded the best overall fit to the data. Class 1 was characterized by a lower mean body mass index (BMI) and increased physical activity. Individuals in Class 2 reported the most binge eating, shape and weight concerns, compensatory behaviors, and negative affect. Class 3 patients reported similar binge eating frequencies to Class 2, with lower levels of exercise or compensation. Class 4 was characterized by the highest average BMI, the most overeating episodes, fewer binge episodes, and an absence of compensatory behaviors. Classes 1 and 3 had the highest and lowest percentage of individuals with a past eating disorder diagnosis, respectively. The latent transition analysis found a higher probability of remission from binge eating among those receiving IPT in Class 2 and CBTgsh in Class 3. CONCLUSIONS The latent class analysis identified 4 distinct classes using baseline measures of eating disorder and depressive symptoms, body weight, and physical activity. Implications of the observed differential treatment response are discussed.
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Broad categories for the diagnosis of eating disorders (BCD-ED): an alternative system for classification.
Walsh, BT, Sysko, R
The International journal of eating disorders. 2009;(8):754-64
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OBJECTIVE Eating Disorder Not Otherwise Specified (EDNOS), a residual category in DSM-IV, is the most commonly used eating disorder diagnosis in clinical settings. A diagnostic scheme, termed Broad Categories for the Diagnosis of Eating Disorders (BCD-ED), is proposed to diminish use of the EDNOS category while preserving the existing eating disorder categories. The objective of this review was to examine the advantages and disadvantages of adopting this scheme for DSM-V. METHOD We reviewed published studies to assess the proportion of individuals with DSM-IV EDNOS that would be reclassified under the BCD-ED system, support for the hierarchy of the three categories, and the potential risk of "overdiagnosis." RESULTS Adopting the BCD-ED scheme would have both advantages and disadvantages, but would likely substantially reduce the number of individuals who would receive an EDNOS diagnosis. DISCUSSION BCD-ED is a potential method of addressing the high frequency of EDNOS, but would be a major change in how eating disorders are categorized.
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Frequency of binge eating episodes in bulimia nervosa and binge eating disorder: Diagnostic considerations.
Wilson, GT, Sysko, R
The International journal of eating disorders. 2009;(7):603-10
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OBJECTIVE In DSM-IV, to be diagnosed with Bulimia Nervosa (BN) or the provisional diagnosis of Binge Eating Disorder (BED), an individual must experience episodes of binge eating is "at least twice a week" on average, for 3 or 6 months, respectively. The purpose of this review was to examine the validity and utility of the frequency criterion for BN and BED. METHOD Published studies evaluating the frequency criterion were reviewed. RESULTS Our review found little evidence to support the validity or utility of the DSM-IV frequency criterion of twice a week binge eating; however, the number of studies available for our review was limited. DISCUSSION A number of options are available for the frequency criterion in DSM-V, and the optimal diagnostic threshold for binge eating remains to be determined.