Intensive Behavioral Therapy Research Articles

Efficacy and Safety of Liraglutide 3.0 mg in Individuals With Overweight or Obesity and Type 2 Diabetes Treated With Basal Insulin: The SCALE Insulin Randomized Controlled Trial.

OBJECTIVEMost individuals with type 2 diabetes also have obesity, and treatment with some diabetes medications, including insulin, can cause further weight gain. No approved chronic weight management medications have been prospectively investigated in individuals with overweight or obesity and insulin-treated type 2 diabetes. The primary objective of this study was to assess the effect of liraglutide 3.0 mg versus placebo on weight loss in this population.RESEARCH DESIGN AND METHODSSatiety and Clinical Adiposity—Liraglutide Evidence (SCALE) Insulin was a 56-week, randomized, double-blind, placebo-controlled, multinational, multicenter trial in individuals with overweight or obesity and type 2 diabetes treated with basal insulin and ≤2 oral antidiabetic drugs.RESULTSIndividuals were randomized to liraglutide 3.0 mg (n = 198) or placebo (n = 198), combined with intensive behavioral therapy (IBT). At 56 weeks, mean weight change was −5.8% for liraglutide 3.0 mg versus −1.5% with placebo (estimated treatment difference −4.3% [95% CI −5.5; −3.2]; P < 0.0001). With liraglutide 3.0 mg, 51.8% of individuals achieved ≥5% weight loss versus 24.0% with placebo (odds ratio 3.41 [95% CI 2.19; 5.31]; P < 0.0001). Liraglutide 3.0 mg was associated with significantly greater reductions in mean HbA1c and mean daytime glucose values and less need for insulin versus placebo, despite a treat-to-glycemic-target protocol. More hypoglycemic events were observed with placebo than liraglutide 3.0 mg. No new safety or tolerability issues were observed.CONCLUSIONSIn individuals with overweight or obesity and insulin-treated type 2 diabetes, liraglutide 3.0 mg as an adjunct to IBT was superior to placebo regarding weight loss and improved glycemic control despite lower doses of basal insulin and without increases in hypoglycemic events.

Implementing a hybrid cognitive-behavioural therapy for pain-related insomnia in primary care: lessons learnt from a mixed-methods feasibility study

ObjectivesTo test the feasibility of implementing a brief but intensive hybrid cognitive behavioural therapy (Hybrid CBT) for pain-related insomnia.DesignMixed-methods, with qualitative process evaluation on a two-arm randomised controlled feasibility trial.SettingPrimary...

Liraglutide 3.0 mg and Intensive Behavioral Therapy (IBT) for Obesity in Primary Care: The SCALE IBT Randomized Controlled Trial.

ObjectivePrevious studies have shown additive weight loss when intensive behavioral therapy (IBT) was combined with weight‐loss medication. The present multisite study provides the first evaluation, in primary care, of the effect of the Centers for Medicare and Medicaid Services–based IBT benefit, delivered alone (with placebo) or in combination with liraglutide 3.0 mg.MethodsThe Satiety and Clinical Adiposity—Liraglutide Evidence in individuals with and without diabetes (SCALE) IBT was a 56‐week, randomized, double‐blind, placebo‐controlled, multicenter trial in individuals with obesity who received liraglutide 3.0 mg (n = 142) or placebo (n = 140) as an adjunct to IBT.ResultsAt week 56, mean weight loss with liraglutide 3.0 mg plus IBT was 7.5% and 4.0% with placebo combined with IBT (estimated treatment difference [95% CI]–3.4% [–5.3% to –1.6%], P = 0.0003). Significantly more individuals on liraglutide 3.0 mg than placebo achieved ≥ 5% weight loss (61.5% vs. 38.8%; odds ratio [OR] 2.5% [1.5% to 4.1%], P = 0.0003), > 10% weight loss (30.5% vs. 19.8%; OR 1.8% [1.0% to 3.1%], P = 0.0469), and > 15% weight loss (18.1% vs. 8.9%; OR 2.3% [1.1% to 4.7%], P = 0.0311). Liraglutide 3.0 mg in combination with IBT was well tolerated, with no new safety signals identified.ConclusionsIn a primary care setting, Centers for Medicare and Medicaid Services–based IBT produced clinically meaningful weight loss at 56 weeks, enhanced by the addition of liraglutide 3.0 mg.

Sharing the 'weight' of obesity management in primary care: integration of registered dietitian nutritionists to provide intensive behavioural therapy for obesity for Medicare patients.

Clinical provision of intensive behavioral therapy for obesity (IBTO) has been a reimbursable treatment for obesity since 2012. However, gaps remain in the literature regarding its impact on patient outcomes. The primary objective of this study was to examine the integration of registered dietitian nutritionist provided IBTO into a primary care setting and evaluate clinic outcomes for Medicare Part B beneficiaries. A secondary objective was to examine intensity of IBTO (quantity of IBTO visits) versus clinical outcomes and influence of socioeconomic factors. A case-control retrospective chart review was conducted at a rural, Academic Family Medicine Clinic in Eastern North Carolina for patients seen between 1 January 2016 and 1 January 2019. In order to be included in the treatment group, patients had to be female, white or black race, have Medicare insurance and a body mass index ≥ 30 kg/m2. Mixed model analysis showed statistically significant improvements in clinical outcomes from IBTO treatment. Weight decreased by nearly 3 pounds, while body mass index was half a point lower. A1C was 0.1 units lower for IBTO patients, and they took prescription medication and average of 6 days less than the control group. Minorities and older respondents experienced smaller, all else constant, and annual fixed effects suggest that differentials widen over time. Registered dietitian nutritionist (RDN) provision of IBTO has demonstrated benefit in improving clinical outcomes including weight, A1C, and reduced medication duration (use) as demonstrated by the IBTO treatment group versus control. IBTO intensity was not predictive of success, and its impact was reduced with older and African American patients. IBTO is beneficial and can be delivered within the primary care setting by a RDN.

Effects of Dietary Self-Monitoring, Physical Activity, Liraglutide 3.0 mg, and Placebo on Weight Loss in the SCALE IBT Trial

Introduction: Individuals who enroll in intensive behavioral therapy (IBT) programs are asked to make several lifestyle changes simultaneously. However, few studies have examined the relative effects of adherence to different treatment components on weight loss. Objective: This secondary analysis of the SCALE IBT trial assessed adherence to the medication regimen, dietary self-monitoring, and physical activity recommendations and their relative contributions to weight change in individuals with obesity who were provided with IBT combined with either liraglutide 3.0 mg or placebo. Methods: SCALE IBT was a double-blinded, multicenter, randomized controlled trial comparing 56-week weight losses in individuals with obesity who received liraglutide 3.0 mg (n = 142) or placebo (n = 140), as an adjunct to IBT. Adherence to dietary self-monitoring, physical activity, and medication usage (liraglutide or placebo) were measured during the 56-week treatment period. A regression model was used to estimate the relative contribution of adherence to each treatment component to weight loss at week 56. Results: The proportion of individuals who adhered to each intervention component decreased over time. Compared with non-adherence, complete adherence to dietary self-monitoring and physical activity recommendations were associated with estimated weight changes of −7.2% (95% CI –10.4 to –4.0; p < 0.0001) and –2.0% (95% CI –3.2 to –0.8; p = 0.0009), respectively. Complete adherence to liraglutide predicted an additional weight loss of –6.5% (95% CI –10.2 to –2.9; p = 0.0005) relative to individuals who did not adhere to the medication regimen, while adherence to placebo did not have a statistically significant effect on weight loss (p = 0.33). Conclusions: High adherence to dietary self-monitoring and use of liraglutide 3.0 mg was associated with clinically relevant weight loss with IBT and adjunctive pharmacotherapy. The effect of adherence to physical activity was significant but smaller.

Impact of Childhood Maltreatment in Borderline Personality Disorder on Treatment Response to Intensive Dialectical Behavior Therapy.

Childhood maltreatment (CM), including emotional, physical, and sexual abuse and emotional and physical neglect, is associated with severity of borderline personality disorder (BPD). However, knowledge on the impact of CM on treatment response is scarce. The authors investigated whether self-reported CM or one of its subtypes affected treatment retention, depressive symptoms, and impulsivity throughout short-term intensive dialectical behavior therapy (I-DBT) in 333 patients with BPD. Data were analyzed with linear and logistic regressions and linear mixed models, using a Bayesian approach. Patients who reported childhood emotional abuse had a higher dropout rate, whereas it was lower in patients who reported childhood emotional neglect. Emotional neglect predicted a greater decrease of depressive symptoms, and global CM predicted a greater decrease of impulsivity. The authors concluded that patients with BPD who experienced CM might benefit from I-DBT in specific symptom domains. Nonetheless, the impact of emotional abuse on higher dropout needs to be considered.

Effects of Liraglutide and Behavioral Weight Loss on Food Cravings, Eating Behaviors, and Eating Disorder Psychopathology.

This exploratory analysis examined the effects of intensive behavioral therapy (IBT) for obesity ("IBT-alone"), IBT plus liraglutide 3.0 mg/d ("IBT-liraglutide"), and IBT plus liraglutide 3.0 mg/d plus 12 weeks of a portion-controlled diet that provided 1,000 to 1,200 kcal/d ("Multicomponent") on changes in food cravings, eating behaviors, and eating disorder psychopathology at 24 and 52 weeks post randomization. Adults with obesity (mean age = 47.6 ± 11.8 years and BMI = 38.4 ± 4.9 kg/m2 ; 79.3% female; 54.0% non-Hispanic white; 44.7% black) were randomized to IBT-alone (n = 50), IBT-liraglutide (n = 50), or Multicomponent (n = 50). At weeks 24 and 52, liraglutide-treated groups reported significantly larger declines in weight concern relative to the IBT-alone group. At week 24, compared with IBT-alone, liraglutide-treated groups reported significantly greater reductions in dietary disinhibition, global eating disorder psychopathology, and shape concern. TheMulticomponent grouphad significantly greater reductions in binge eating at week 24 relative tothe IBT-alonegroup. However, differences among groups were no longer significant at week 52. Groups did not differ in total food cravings at week 24 or 52. The combination of liraglutide and IBT was associated with greater short-term improvements in dietary disinhibition, global eating disorder psychopathology, and shape concern than IBT alone.

Changes in health-related quality of life with intensive behavioural therapy combined with liraglutide 3.0 mg per day.

This study examined the effects of intensive behavioural therapy (IBT) for obesity (IBT-alone), IBT plus liraglutide 3.0 mg/day (IBT-liraglutide), and IBT-liraglutide combined with 12 weeks of a portion-controlled diet (Multicomponent) on changes in general health-related (HR) quality of life (QoL) and weight-related QoL. Adults with obesity (79.3% female; 54.0% white; 44.7% black; mean age = 47.6 ± 11.8 years and body mass index = 38.4 ± 4.9 kg/m2 ) were randomized to IBT-alone (n = 50), IBT-liraglutide (n = 50) or Multicomponent (n = 50). General HRQoL was measured with the Short Form-36 (SF-36), and weight-related QoL was assessed with the Impact of Weight on Quality of Life-Lite scale. At week 52, participants in the three groups lost 6.1 ± 1.3%, 11.5 ± 1.3% and 11.8 ± 1.3% of initial body weight, respectively. Both liraglutide-treated groups were significantly more likely than IBT-alone to achieve clinically meaningful improvements in total weight-related QoL. They also both achieved greater improvements than IBT-alone in weight-related public distress and in general mental health, as measured by the SF-36 mental component summary score. Independent of treatment group, greater categorical weight loss was associated with greater improvements in several domains of both general and weight-related QoL. The addition of liraglutide to IBT appeared to improve aspects of both general HRQoL and weight-related QoL.

Time intensive cognitive behavioural therapy for a specific phobia of vomiting: A single case experimental design

Background and ObjectivesSpecific Phobia of Vomiting (SPOV) may be difficult to treat, and to date only one RCT has been published. Specific Phobias can be successfully treated using time intensive treatment formats. Imagery rescripting (ImRs) has also been shown to be a successful component for treating various anxiety disorders. The present study aims to evaluate the effectiveness of time intensive CBT and ImRs at reducing symptoms in SPOV. MethodsA multiple baseline ABCADE single case experimental design (SCED) was used to monitor symptoms across time in eight participants. The Specific Phobia of Vomiting Inventory (SPOVI) was administered to measure SPOV symptoms at each clinical session. Visual analysis of graphed data was used to compare data across treatment phases. Reliable and clinically significant change was also calculated on the SPOVI at 6-month follow up. ResultsFindings suggest that time intensive CBT is associated with improvements across symptoms of SPOV. There was limited support for ImRs in the current study; however, informal discussion of aversive memories of vomiting, and formulation of the problem may be helpful in its own right in treatment of SPOV. Seven out of eight participants (87.5%) achieved reliable improvement and five (62.5%) achieved clinically significant change on the SPOVI at 6-month follow up. Time intensive treatment was associated with high client satisfaction ratings. LimitationsLimitations include lack of measurement of therapist adherence to protocol, and a short period of daily symptom monitoring in between ImRs and intensive treatment phases. ConclusionsTime intensive CBT including an ImRs component may be an effective and acceptable treatment in reducing SPOV symptomatology. Further research using larger sample sizes in a RCT is needed.

Weight Loss After Stroke Through an Intensive Lifestyle Intervention (Group Lifestyle Balance-Cerebrovascular Accident): Protocol for a Randomized Controlled Trial.

BackgroundWeight gain can be a consequence of stroke, or cerebrovascular accident (CVA), because of impaired mobility, behavioral and emotional disorders, and sensory losses. Weight gain increases the patient’s risk of recurrent stroke and chronic diseases, such as diabetes, metabolic syndrome, and pulmonary and heart disease. Approaches to weight loss in this population are lacking, although necessary because of the unique physiological and cognitive needs of persons after a stroke. Evidence shows that intensive behavioral therapy interventions that address both physical activity and diet offer the greatest potential for weight loss. The Group Lifestyle Balance (GLB) intervention is a 12-month, evidence-based weight loss program that has been used extensively with the general population; this program was modified to meet the needs of people who have had a stroke (GLB-CVA).ObjectiveThis randomized controlled trial (RCT) aims to examine the efficacy of the GLB-CVA on weight and secondary outcomes, compared with that of a waitlist control group.MethodsThis RCT will enroll and randomize 64 patients over an 18-month period.ResultsCurrently, 51 people are waitlisted, with 23 out of 51 screened and 16 out of 23 eligible.ConclusionsIt is anticipated that the findings from this RCT will contribute to the evidence base regarding weight loss strategies for people living with stroke.Clinical TrialClinicalTrials.gov NCT03873467; https://clinicaltrials.gov/ct2/show/NCT03873467

Disseminating Cognitive-Behavioral Therapy for obsessive compulsive disorder: Comparing in person vs. online training modalities

Despite the efficacy of cognitive behavioral therapy (CBT) for obsessive-compulsive disorder (OCD), most patients do not have access. This longitudinal study examined the effectiveness of disseminating CBT for OCD via: (a) the online, low-intensity Psychiatry Academy, targeting clinicians new to CBT for OCD, and (b) the in-person, intensive International OCD Foundation's Behavior Therapy Training Institute (BTTI), marketed to experienced clinicians in OCD. Clinicians enrolled in the BTTI (n = 273) or Psychiatry Academy (n = 118) from 4/2016–11/2018 completed assessments before, after, and 6-months following their training. As expected, BTTI clinicians had more pre-existing experience in CBT/OCD compared to the Psychiatry Academy. A significant effect of time indicated: (a) increased self-reported comfort assessing/treating OCD, (b) more positive beliefs about exposure, (c) improved knowledge of CBT/OCD, and (d) greater use of empirically supported principles (ESPs) following the trainings. Time x training interactions indicated that, relative to the BTTI, Psychiatry Academy attendees began with less comfort and more negative beliefs about exposure, but these differences diminished following the training (differences remained for the pre/post quiz and utilization of ESPs). Results suggest the promise of accessible, online trainings on CBT for OCD; yet, research is needed on the incremental benefit of progressing from introductory to advanced courses.

A Protocol to Deliver Intensive Behavioral Therapy (IBT) for Obesity in Primary Care Settings: The MODEL-IBT Program.

The Centers for Medicare and Medicaid Services (CMS) initiated coverage of intensive behavioral therapy (IBT) for obesity in 2011, providing beneficiaries 14 to 15 brief, individual counseling visits in 6 months. CMS offered general recommendations for delivering IBT but did not provide an evidence-based treatment protocol, which was the objective of the present research. This review describes the evidence that CMS considered in developing its IBT benefit. It also examines weight losses produced by the intensive lifestyle intervention in the Diabetes Prevention Program(DPP), as well an adapted version of the DPP delivered (for the first 6 months) on the visit schedule recommended by CMS. This new protocol, which was evaluated in a recent randomized trial, provided 14 visits in the first 24 weeks, with 7 additional monthly visits through week 52. As reported previously, the 50 participants with obesity assigned to the new IBT protocol lost a mean of 5.4% of their initial weight at week 24; 46% of participants lost ≥ 5% of their baseline weight. At 1 year, the mean loss was 6.1%, and 44% of participants lost ≥ 5%. With these generally favorable results, the IBT protocol is being posted online for practitioners and researchers to use.

Ten-year Medicare budget impact of increased coverage for anti-obesity intervention

Aims: To estimate the long-term budget impact of expanding Medicare coverage of anti-obesity interventions among adults aged 65 and older in the US.Materials and methods: This study analyzed a representative sample of Medicare beneficiaries from the combined 2008–2016 National Health and Nutrition Examination Surveys. Population characteristics, cost and effectiveness of anti-obesity interventions, and the sustainability of weight loss in real-life were modeled to project the budgetary impact on gross Medicare outlay over 10 years. Hypothetical scenarios of 50% and 67% increases in intervention participation above base case were used to model moderate and extensive Medicare coverage expansion of intensive behavior therapy and pharmacotherapy.Results: For each Medicare beneficiary receiving anti-obesity treatment, we estimate Medicare savings of $6,842 and $7,155 over 10 years under moderate and extensive coverage utilization assumptions, respectively. The average cost of intervention is $1,798 and $1,886 per treated participant. Taking the entire Medicare population (treated and untreated) into consideration, the estimated 10-year budget savings per beneficiary are $308 and $339 under moderate and extensive assumptions, respectively. Sensitivity analysis of drug adherence rate and weight-loss efficacy indicated a potential variation of budget savings within 7% and 22% of the base case, respectively. Most of the projected cost savings come from lower utilization of ambulatory services and prescription drugs.Limitations: Due to the scarcity of studies on the efficacy of pharmacotherapy among older adults with obesity, the simulated weight loss and long-term maintenance effects were derived from clinical trial outcomes, in which older adults were mostly excluded from participation. The model did not include potential side-effects from anti-obesity medications and associated costs.Conclusions: This analysis suggests that expanding coverage of anti-obesity interventions to eligible individuals could generate $20–$23 billion budgetary savings to Medicare over 10 years.

Rapid improvements in emotion regulation predict eating disorder psychopathology and functional impairment at 6-month follow-up in individuals with bulimia nervosa and purging disorder.

We previously demonstrated that early improvements in access to emotion regulation strategies during the first 4 weeks of intensive cognitive behavior therapy (CBT)-based eating disorder (ED) treatment predicted a range of post-treatment outcomes. This follow-up article examines whether early improvements in access to emotion regulation strategies continue to predict good treatment outcomes at 6 months post-treatment. Participants were 76 patients with bulimia nervosa or purging disorder who participated in the original study and the 6-month follow-up assessment. Hierarchical regression models were used to examine whether early improvements in emotion regulation strategies predicted 6-month follow-up outcomes. After controlling relevant covariates and rapid and substantial behavior change, greater early improvements in access to emotion regulation strategies during the first 4 weeks of intensive treatment predicted lower overall ED psychopathology and ED-related functional impairment 6 months after treatment. They did not predict abstinence from binge, vomit, and laxative use behaviors during the follow-up period. Individuals who learn early in treatment that they can use skills to more effectively regulate emotions have better treatment outcomes on some variables 6 months after treatment. Teaching emotion regulation skills in the first phase of CBT for ED may be beneficial, particularly for individuals with baseline difficulties.

Evaluation of an Integrated Intensive Cognitive Behavioral Therapy Treatment Within Addiction Care

The study aimed to evaluate an integrated intensive cognitive behavioral therapy (CBT) group treatment for people with substance-related syndrome in outpatient care and to identify eventual gender differences. The study population consisted of 35 outpatients (18 male, 17 female) at a clinic in Western Sweden. The patients completed a four-month period of intensive group therapy and participated in the data collection at admission and discharge. The data were collected using the following inventories: Beck Depression and Anxiety Inventories, Rosenberg Self-Esteem Scale, Hopelessness Scale, and Trait Hope Scale. Results showed decreases in anxiety, depression and experience of hopelessness, and increases in self-esteem and hope. In females, the most dramatic improvement was measured for the anxiety and depression attributes, while in males the strongest effect was measured for hope and self-esteem. This study provides clinical evidence of the positive effects of integrated intensive CBT in outpatient care of people with substance-related syndrome.

SAT-097 Weight Loss With Liraglutide 3.0 Mg Versus Placebo For Individuals Who Adhere To The Trial Drug: A Secondary Analysis From SCALE IBT

The objective of the SCALE IBT trial (NCT02963935) was to compare the weight loss of liraglutide 3.0 mg, a medication approved by the Food and Drug Administration for chronic weight management, to placebo, both in combination with 56 weeks of intensive behavior therapy (IBT) (i.e. reduced calorie intake, increased physical activity [max target: 250 mins/week], and 23 counseling sessions). The primary outcomes of the study were assessed in the intention-to-treat sample, regardless of individuals’ medication adherence. The weight loss estimated in the primary analysis, regardless of drug adherence, was 7.5% versus 4.0% for liraglutide 3.0 mg and placebo, respectively, reflecting a treatment difference favoring liraglutide 3.0 mg of 3.5% (95% CI: 1.6%; 5.3%; p=0.0003). In this pre-specified secondary analysis, we sought to determine the expected effect of liraglutide 3.0 mg on weight loss, as compared to placebo, if all randomized individuals had adhered to study drug for 56 weeks. A total of 282 individuals with obesity (BMI ≥30 kg/m2) were randomized in a 1:1 ratio to 56 weeks of IBT combined with daily injections of either liraglutide 3.0 mg or placebo. The weight loss, based on the assumption that all individuals adhered to the medication, was estimated using two different approaches. The first approach (mixed model repeated measures; MMRM) estimated the weight loss that would have been achieved if all individuals adhered to the trial drug by utilizing information from individuals still on drug after the point of a given individual’s discontinuation to provide a (counter-factual) weight change as if the individual in question had not discontinued the drug. The second (covariate) approach used a regression model to calculate the weight change of individuals with full adherence to trial drug by including adherence as a moderator of the effect of treatment condition on weight change. The MMRM approach yielded a weight loss difference of 4.6% (95% CI: 2.6%; 6.5%; p<0.0001), and the covariate approach yielded a weight loss difference of 4.6% (95% CI: 2.8%; 6.5%; p<0.0001), with both estimates favoring liraglutide 3.0 mg. As such, there was good agreement between the two statistical approaches for estimating the effect of liraglutide 3.0 mg versus placebo for individuals who adhere to trial product for 56 weeks. The estimated placebo-subtracted weight loss for liraglutide at week 56 of approximately 4.6% in medication-adherent individuals therefore indicates that underlying assumptions are robust. We believe this finding is an important supplement to the study’s primary outcome and can inform practitioners’ expectations when prescribing liraglutide 3.0 mg in combination with IBT for 56 weeks. Supported by Novo Nordisk.

MON-120 Effect of Weight Loss on Physical Function Measured by the 6-Minute Walking Distance Test in Individuals with Obesity: Results from the SCALE IBT Trial of Liraglutide 3.0 Mg

In clinical trials for weight management, changes in physical function are typically assessed with self-report HRQoL questionnaires. In this trial we aimed to objectively measure the effect of weight loss on walking capacity, as measured with the 6-minute walk test, a sub-maximal exercise test used to assess cardiopulmonary and musculoskeletal systems. The SCALE IBT trial (NCT02963935) was a 56-week, randomized, double-blind, US-based multicenter trial of liraglutide 3.0 mg vs placebo, with intensive behavior therapy (IBT) (i.e. reduced calorie intake, increased physical activity [max target: 250 min/week], and 23 counseling visits) in both arms. A key secondary endpoint was the change in 6-minute walking distance (6MWD), a test for walking capacity measured by total distance walked along a 20-m marked walkway over 6 minutes. To our knowledge, this is the first trial with pharmacological weight management to explore changes in the 6MWD in response to treatment. This post-hoc analysis examined the association between baseline body mass index (BMI) and 6MWD, and change in weight and 6MWD. For the trial, individuals aged ≥18 y with a BMI ≥30 kg/m2 and without diabetes were randomized 1:1 to IBT plus liraglutide 3.0 mg or placebo. The change in body weight and 6MWD from baseline to week 56 was calculated using analysis of covariance (ANCOVA), with treatment, gender and BMI as factors and baseline endpoint [body weight or 6MWD] as a covariate. Linear regression was used for the correlation analysis of the association between 6MWD and BMI. There were 282 individuals in the full analysis set (47 y, 17% male, BMI 39 kg/m2), of whom 142 were randomized to liraglutide 3.0 mg and 140 to placebo. At 56 weeks, mean weight loss was 7.5% with liraglutide 3.0 mg and 4.0% with placebo, estimated treatment difference (ETD [95% CI] 3.5% [1.6, 5.3]; p=0.0003). Improvement in 6MWD was 49.5 m vs. 46.4 m, respectively, from a mean baseline of 439 m (ETD [95% CI] 3.1 [-12.7, 18.9]; p=0.70). The post-hoc correlation analysis showed a linear relationship between 6MWD and BMI. Linear regression of baseline 6MWD vs. baseline BMI showed that on average an individual with a BMI that was 1 kg/m2 lower compared to another individual was able to walk 4.9 m longer in 6 minutes (slope [95% CI] -4.9 m/(kg/m2) [-6.2, -3.6]; p<0.0001). This relationship was also demonstrated in a linear regression analysis of change in 6MWD at 56 weeks vs. change in BMI at 56 weeks, where on average an individual improved 6MWD by 5.0 m for each BMI decrease of 1 kg/m2 (slope [95% CI] -5.0 m/(kg/m2) [-7.6, -2.5]; p<0.0001). The intercept (i.e. change in 6MWD with no change in BMI) was 36.3 m, most likely primarily reflecting the effect of increased physical activity as a part of the IBT intervention. This post-hoc analysis showed that greater weight loss was associated with greater improvements in 6MWD in a linear manner, indicating gains in walking capacity. Supported by Novo Nordisk.

SAT-099 Liraglutide 3.0 mg as an Adjunct to Intensive Behavior Therapy in Individuals with Obesity: SCALE IBT 56-Week Randomized, Double-Blind, Placebo-Controlled Trial

In this 56-week, randomized, double-blind, US-based multicenter trial (NCT02963935) we investigated the effects of liraglutide 3.0 mg vs placebo, as adjunct to intensive behavior therapy (IBT) (i.e. reduced calorie intake, increased physical activity [max target: 250 min/week], and 23 counseling sessions). Here we report the effects of treatment on weight change (co-primary endpoints: mean change in body weight [%] and proportion of individuals losing ≥5%), glycemic variables, cardiometabolic risk factors, safety and tolerability. Individuals aged ≥18 years with a body mass index (BMI) ≥30 kg/m2 and without diabetes were randomized 1:1 to liraglutide 3.0 mg or placebo along with IBT. Continuous and categorical variables were calculated using analysis of covariance (ANCOVA) and logistic regression respectively, with treatment, gender and BMI as factors and baseline endpoint as a covariate. Missing values were handled using a jump-to-reference multiple imputation model. There were 282 individuals in the full analysis set; 142 were randomized to liraglutide 3.0 mg (45 y, 16% male, 109 kg, 39 kg/m2) and 140 to placebo (49 y, 17% male, 107 kg, 39 kg/m2); 99% and 93% completed the trial, respectively. The intention to treat analysis demonstrated weight loss at 56 weeks of 7.5% with liraglutide 3.0 mg and 4.0% with placebo (estimated treatment difference (ETD) [95% CI], 3.5% [5.3, 1.6]; p=0.0003). Weight loss in individuals on trial product at 56 weeks was 9.1% (n=114) and 4.8% (n=103), respectively. The proportion of individuals achieving ≥5% weight loss was 61.5% with liraglutide 3.0 mg and 38.8% with placebo (estimated odds ratio (OR) 2.5 [1.5, 4.1], p=0.0003). The proportion who lost >10% was 30.5% and 19.8% (OR 1.8 [1.01, 3.1], p=0.0469), and >15% was 18.1% and 8.9% (OR 2.3 [1.1, 4.7], p=0.0311, respectively. Change in waist circumference was -9.4 cm with liraglutide 3.0 mg vs -6.7 cm with placebo (ETD -2.7 cm [-4.7, -0.8], p=0.006). Significant improvements at 56 weeks were seen for liraglutide 3.0 mg vs placebo in both HbA1c (ETD -0.10% [-0.16, -0.04], p=0.0008) and fasting plasma glucose (ETD ‑0.23 mmol/L [-0.36, -0.11] p=0.0002). Blood pressure (BP) reductions were observed in both treatment arms at 56 weeks, but there were no significant differences between groups in systolic (ETD -2.2 mmHg [‑4.9, 0.5], p=0.11) or diastolic BP (ETD -0.2 mmHg [‑2.2, 1.8], p=0.87), or heart rate (ETD 1.3 bpm [-0.8, 3.4], p=0.23). Lipids were improved vs baseline but no significant differences between treatment arms were observed at 56 weeks (all p>0.05). Liraglutide 3.0 mg was generally well tolerated and no new safety signals were observed in this study. The most frequent adverse events were gastrointestinal (liraglutide 3.0 mg: 71%; placebo: 49%). In conclusion, liraglutide 3.0 mg as an adjunct to IBT resulted in significantly greater weight loss, as compared to IBT and placebo. Supported by Novo Nordisk.

SAT-105 Weight Loss As Determined By Adherence To Reduced Caloric Diet, Increased Physical Activity, Liraglutide 3.0 Mg and Placebo: A Sub-analysis Of The SCALE IBT Trial

Liraglutide 3.0 mg is approved by the Food and Drug Administration for chronic weight management in the United States as an adjunct to reduced caloric diet and increased physical activity. The objective of the SCALE IBT trial (NCT02963935) was to compare the weight loss for liraglutide 3.0 mg to placebo, both in combination with intensive behavioral therapy (IBT) (i.e. reduced calorie intake, increased physical activity [max target: 250 min/week], and 23 counseling sessions). The present pre-specified exploratory sub-analysis determined the individual contributions of adherence to study medication, and to the adjunct diet and physical activity interventions on weight change. A total of 282 individuals with obesity (BMI ≥30 kg/m2) were randomized to treatment for 56 weeks. Adherence to study medication was recorded on a weekly basis by individuals’ self-reports of taking at least one dose in the preceding week. Adherence to dietary recommendations was assessed via the individuals’ completion of food diaries (at least one entry per day on 5 days or more in the preceding week was considered adherent). Adherence to physical activity recommendations was assessed using electronic activity trackers by comparing measured active minutes to the program goal (starting at 100 min/week increasing to 250 min/week; achieving 50% of target in the preceding week was considered to be adherent). The proportion of randomized individuals who were adherent decreased steadily through the study for all three intervention components. The effect of adherence on body weight was evaluated through an ANOVA model that included dietary information, physical activity and medication adherence and their interaction with randomized treatment. The model was reduced by removing non-significant terms, leaving only the main effect of adherence to diet and physical activity, and the effects of adherence to study medication. As estimated in the final model, adherence to dietary recommendations throughout the trial provided a ‑7.2% reduction in initial body weight (95% CI: -10.4%; -4.0%; p<0.0001); adherence to physical activity recommendations provided -2.0% (95% CI: ‑3.2%; -0.8%; p=0.0009); and adherence to liraglutide 3.0 mg provided an additional loss of -6.5% (95% CI: ‑10.2%; ‑2.9%; p=0.0005). As expected, adherence to placebo did not have a statistically significant effect on weight loss (mean contribution of -1.9%, 95% CI: -5.6%; 1.9%; p=0.33). In conclusion, this sub-analysis indicated that adherence to dietary recommendations and liraglutide injections provided clinically relevant weight loss, whereas the effect of physical activity was more modest in size. Supported by Novo Nordisk.

A Patient-Centered PaTH to Address Diabetes: Protocol for a Study on the Impact of Obesity Counseling.

BackgroundOverweight and obesity are America’s number one health concern. The prevalence of obesity in the United States is greater than 36%, a rate that has doubled since 1970. As the second most preventable cause of death, obesity is a risk factor for diabetes, cardiovascular disease, stroke, and cancer, all major causes of death. Primary care clinics may be an ideal setting for weight control interventions to help manage and prevent diabetes. For this reason, the Centers for Medicare and Medicaid Services (CMS) implemented a health care procedure coding system code for intensive behavioral therapy (IBT) for obesity within primary care in 2012 to facilitate payment for addressing obesity, which was followed by broader coverage by most insurers for IBT for adults in 2013. However, the impact of this coverage on patient-centered outcomes is largely unknown.ObjectiveThe overarching goal of this study is to understand the comparative effectiveness of obesity counseling as covered by CMS and other insurers in improving weight loss for adults either with or at increased risk for type 2 diabetes.MethodsThis study leverages the novel infrastructure of the Patient-Centered Outcomes Research Institute–funded PaTH Clinical Data Research Network. The PaTH network is comprised of Geisinger Health System, Johns Hopkins University, Johns Hopkins Health System, Lewis Katz School of Medicine at Temple University, Temple Health System, Penn State College of Medicine, Penn State Milton S Hershey Medical Center, University of Pittsburgh, UPMC and UPMC Health Plan, and the University of Utah. Electronic health record (EHR) data will originate from the 6 PaTH health systems. Specifically, we will (1) evaluate the impact of broader preventive service coverage for obesity screening and counseling on weight loss, diabetes incidence, and diabetes outcomes in patients with diabetes or at increased risk for diabetes (defined by body mass index [BMI] ≥25). We will determine how the annual probability of receiving obesity and/or nutritional counseling changed pre- and postpolicy across all insurers in a cohort of patients with diabetes and at high risk for diabetes. We will (2) compare patient weight loss and diabetes-related outcomes among those who receive obesity screening and counseling with those who do not, following implementation of preventive service coverage. We will examine postpolicy impact of obesity screening and counseling in a cohort of patients with diabetes and at increased risk for diabetes. Specific outcomes to be examined include weight loss, diabetes incidence, and diabetes outcomes. Exploratory outcomes will include patient-reported outcomes. Furthermore, we will determine patient characteristics, including demographics, and practice characteristics, including provider type.ResultsOur PCORI-funded study is underway. To date, we have obtained our second data extraction from the PaTH CDRN and are performing data editing and cleaning. Next steps include analysis of early policy change.ConclusionsGiven patients who are overweight are at highest risk for diabetes, improved weight management services could prevent diabetes and its negative health outcomes. Comparing weight and diabetes outcomes in 3 states using EHRs and claims data before and after this policy was implemented using the PaTH Network will allow important insight into policy effectiveness.International Registered Report Identifier (IRRID)DERR1-10.2196/12054