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

OBJECTIVE: 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. METHODS: 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. RESULTS: 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%. CONCLUSIONS: With these generally favorable results, the IBT protocol is being posted online for practitioners and researchers to use.

A Toolbox Approach to Obesity Treatment in Urban Safety-Net Primary Care Clinics: a Pragmatic Clinical Trial.

BACKGROUND: There is a need for new strategies to improve the success of obesity treatment within the primary care setting. OBJECTIVE: To determine if patients offered low out-of-pocket cost weight management tools achieved more weight loss compared to usual care. DESIGN: Twelve-month pragmatic clinical weight loss trial with a registry-based comparator group performed in primary care clinics of an urban safety-net hospital. PARTICIPANTS: From a large clinical registry, we randomly selected 428 patients to have the opportunity to receive the intervention. INTERVENTIONS: Medical weight management tools-partial meal replacements, recreation center vouchers, pharmacotherapy, commercial weight loss program vouchers, and a group behavioral weight loss program-for $5 or $10 monthly. Patients chose their tools, could switch tools, and could add a second tool at 6 months. MAIN MEASURES: The primary outcome was the proportion of intervention-eligible patients who achieved ≥ 5% weight loss. The main secondary outcome was the proportion of on-treatment patients who achieved ≥ 5% weight loss. KEY RESULTS: Overall, 71.3% (305 of 428) had available weight measurement data/PCP visit data to observe the primary outcome. At 12 months, 23.3% (71 of 305) of intervention-eligible participants and 15.7% (415 of 2640) of registry-based comparators had achieved 5% weight loss (p < 0.001). Of the on-treatment participants, 34.5% (39 of 113) achieved 5% weight loss. Mean percentage weight loss was - 3.15% ± 6.41% for on-treatment participants and - 0.30% ± 6.10% for comparators (p < 0.001). The initially preferred tools were meal replacements, pharmacotherapy, and recreation center passes. CONCLUSIONS: Access to a variety of low out-of-pocket cost weight management tools within primary care resulted in ≥ 5% body weight loss in approximately one quarter of low-income patients with obesity. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01922934.

Communication between patients and primary care physicians after behavioural weight loss: an observational study.

Primary care physicians can play a key role in supporting patients after behavioural weight loss, though little is known about communication between patients and physicians during this time. Adults (n=139) in a behavioural weight loss trial (delivered outside of primary care) who attended a primary care appointment after an initial weight loss period were surveyed to assess weight-related communication at their most recent appointment. Most participants (78%) reported discussing weight with their physician. Participants who discussed weight, compared to those who did not, lost more weight, had higher blood pressure, and were more likely to be male. Most (89%) reported that their physician was supportive of their weight loss, but only a few participants (6.9%) reported that their physician gave feedback on medical parameters. Areas for improvement identified include physicians providing universal support for modest weight changes and providing interpretation of medical measurements that changed due to weight loss.

Two-Year Results of Think Health! ¡Vive Saludable!: A Primary Care Weight-Management Trial.

OBJECTIVE: Think Health! ¡Vive Saludable! evaluated a moderate-intensity, lifestyle behavior-change weight-loss program in primary care over 2 years of treatment. Final analyses examined weight-change trajectories by treatment group and attendance. METHODS: Adult primary care patients (n = 261; 84% female; 65% black; 16% Hispanic) were randomly assigned to Basic Plus (moderate intensity; counseling by primary care clinician and a lifestyle coach) or Basic (clinician counseling only). Intention-to-treat analyses used all available weight measurements from data collection, treatment, and routine clinical visits. Linear mixed-effects regression models adjusted for treatment site, gender, and age, and sensitivity analyses evaluated treatment attendance and the impact of loss to follow-up. RESULTS: Model-based estimates for 24-month mean (95% CI) weight change from baseline were -1.34 kg (-2.92 to 0.24) in Basic Plus and -1.16 kg (-2.70 to 0.37) in Basic (net difference -0.18 kg [-2.38 to 2.03]; P = 0.874). Larger initial weight loss in Basic Plus was attenuated by a ~0.5-kg rebound at 12 to 16 months. Each additional coaching visit was associated with a 0.37-kg greater estimated 24-month weight loss (P = 0.01). CONCLUSIONS: These findings in mostly black and Hispanic female primary care patients suggest that strategies to improve treatment attendance may improve weight loss resulting from moderate-intensity counseling.

Marijuana's Influence on Pain Scores, Initial Weight Loss, and Other Bariatric Surgical Outcomes.

INTRODUCTION: Pain management can be challenging following bariatric surgery, and patients with obesity tend to increase opioid use after undergoing surgery. This report quantifies marijuana (MJ) use and its relationship to pain and other surgery-related outcomes in a population from a state that has legalized MJ. METHODS: Data were collected for consecutive patients undergoing weight reduction surgeries between May 1, 2014 and July 31, 2015. Demographics, preoperative comorbidities, medications, and perioperative opioid use were analyzed. The primary outcome evaluated was inpatient opioid pain medication use quantified using natural log morphine equivalents. Secondary outcomes included percentage of total body weight loss after three months, postoperative complications, and changes in medical comorbidities. RESULTS: A total of 434 patients, among whom 36 (8.3%) reported MJ use, comprised the study population. Perioperative opioid requirements were significantly higher in the MJ-user group (natural log morphine equivalents of 3.92 vs 3.52, p = 0.0015) despite lower subjective pain scores (3.70 vs 4.24, p = 0.07). MJ use did not affect percentage of 90-day total body weight loss, development of postoperative complications, or improvement in medical comorbidities. CONCLUSION: Perioperative opioid use was significantly higher in the MJ-user group despite lower subjective pain scores. The difference in opioid requirements suggests an interaction between MJ use and opioid tolerance or pain threshold. The percentage of total body weight loss, improvement in medical comorbidity, and incidence of postoperative complications at 90-day follow-up were not affected by MJ use in this cohort analysis.

Differences in perspectives regarding diabetes management between health care providers and patients.

Chronic conditions such as type 2 diabetes are challenging to manage. This is often due to failure of both the practice of effective diabetes self-care management by the patient and inadequate intervention strategies and follow-up by the health care provider (HCP). The aims of the study are (i) to use a social marketing survey approach to understand the gaps in perceptions between patients with type 2 diabetes and HCPs on diabetes-related topics such as levels of awareness, use and satisfaction with community resources, and perceived barriers to self-management and (ii) to present the results of a public awareness campaign/diabetes management demonstration project (Cities for Life) on change in discordant views between HCPs and patients. The study was conducted as a separate sample pre-post quasiexperimental design study as part of a clinical-community program, Cities for Life in Birmingham, AL. The surveys were administered before (Wave 1 or W1 in 2012) and after (Wave 2 or W2 in 2013) implementation of the Cities for Life program. HCPs (n = 50 and 48) and patients with type 2 diabetes and prediabetes (n = 201 and 204) responded to surveys at W1 and W2, respectively. At both timepoints, HCPs and patients identified diabetes as a major health priority and stated education and information as the most valuable aspects of community-based programs (CBPs). Although 86% of HCPs reported recommending CBPs for lifestyle modification and that their patients frequently participated in CBPs (W1 = 70%; W2 = 82%), fewer patients reported participation (W1 = 31%; W2 = 22%). Patients frequently were not able to name any CBPs for diabetes prevention or treatment (W1 = 45%; W2 = 59%) despite a large proportion perceiving CBPs as valuable (W1 = 41%; W2 = 39%). A substantial percentage of patients reported receiving "a lot of support" from family/friends/or coworkers (W1 = 54%; W2 = 64%; p < .05), but HCPs believed that a much lower proportion of their patients received "a lot of support" (W1 = 0%, W2 = 10%, p < .05). Patients and HCPs independently reported patients' lack of motivation as one of the main barriers to better diabetes care. HCPs and patients reported discordant views regarding two important aspects of diabetes self-management: the use of community resources and the degree of social suppor t received by patients. HCPs overestimated the patients' use of community resources, and underestimated the patients' degree of social support. Trans-disciplinary interventions to address patients' lack of motivation and to engage social support networks may improve communication and mutual understanding about the role and benefits of community resources in diabetes and other chronic disease self-management.

The Science of Obesity Management: An Endocrine Society Scientific Statement.

The prevalence of obesity, measured by body mass index, has risen to unacceptable levels in both men and women in the United States and worldwide with resultant hazardous health implications. Genetic, environmental, and behavioral factors influence the development of obesity, and both the general public and health professionals stigmatize those who suffer from the disease. Obesity is associated with and contributes to a shortened life span, type 2 diabetes mellitus, cardiovascular disease, some cancers, kidney disease, obstructive sleep apnea, gout, osteoarthritis, and hepatobiliary disease, among others. Weight loss reduces all of these diseases in a dose-related manner-the more weight lost, the better the outcome. The phenotype of "medically healthy obesity" appears to be a transient state that progresses over time to an unhealthy phenotype, especially in children and adolescents. Weight loss is best achieved by reducing energy intake and increasing energy expenditure. Programs that are effective for weight loss include peer-reviewed and approved lifestyle modification programs, diets, commercial weight-loss programs, exercise programs, medications, and surgery. Over-the-counter herbal preparations that some patients use to treat obesity have limited, if any, data documenting their efficacy or safety, and there are few regulatory requirements. Weight regain is expected in all patients, especially when treatment is discontinued. When making treatment decisions, clinicians should consider body fat distribution and individual health risks in addition to body mass index.

Treatment of Obesity in Primary Care.

This article outlines some of the behavioral, pharmacologic, and surgical interventions available to primary care physicians (PCPs) to help their patients with weight management. Studies on lifestyle modification, commercial weight loss programs, and medical and surgical options are reviewed. Several clinical suggestions on obesity management that PCPs can take back and use immediately in office practice are offered.

A System-Level Approach to Overweight and Obesity in the Veterans Health Administration.

Healthcare systems are challenged by steady increases in the number of patients who are overweight and obese. Large-scale, evidence-based behavioral approaches for addressing overweight and obesity have been successfully implemented in systems such as the Veterans Health Administration (VHA). These population-based interventions target reduction in risk for obesity-associated conditions through lifestyle change and weight loss, and are associated with modest weight loss. Despite the fact that VHA has increased the overall reach of these behavioral interventions, the number of high-risk overweight and obese patients continues to rise. Recommendations for weight loss medications and bariatric surgery are included in clinical practice guidelines for the management of overweight and obesity, but these interventions are underutilized. During a recent state of the art conference on weight management held by VHA, subject matter experts identified challenges and gaps, as well as potential solutions and overarching policy recommendations, for implementing an integrated system-wide approach for improving population-based weight management.

Investing in Obesity Treatment: Kaiser Permanente's Approach to Chronic Disease Management.

Kaiser Permanente, an integrated health care delivery system in the USA, takes a "whole systems" approach to the chronic disease of obesity that begins with efforts to prevent it by modifying the environment in communities and schools. Aggressive case-finding and substantial investment in intensive lifestyle modification programs target individuals at high risk of diabetes and other weight-related conditions. Kaiser Permanente regions are increasingly standardizing their approach when patients with obesity require treatment intensification using medically supervised diets, prescription medication to treat obesity, or weight loss surgery.

Impact of intensive lifestyle intervention on preference-based quality of life in type 2 diabetes: Results from the Look AHEAD trial.

OBJECTIVE: To assess the effect of an intensive lifestyle intervention (ILI) compared with standard diabetes support and education (DSE) on preference-based health-related quality of life (HRQOL) in persons with overweight or obesity and type 2 diabetes. METHODS: Look AHEAD was a multisite, randomized trial of 5,145 participants assigned to ILI or DSE. Four instruments were administered during the trial: Feeling Thermometer (FT), Health Utilities Index Mark 2 (HUI2), Health Utilities Index Mark 3 (HUI3), and Short Form 6D (SF-6D). Linear mixed effect models were used to estimate the mean difference in preference scores by treatment group for 9 years. RESULTS: The ILI had higher mean FT (0.019, 95% CI, 0.015-0.024, P < 0.001) and SF-6D (0.011, 95% CI, 0.006-0.014, P < 0.001) scores than the DSE. No significant group differences were observed for the HUI2 (0.004, 95% CI, -0.003 to 0.010, P = 0.23) and HUI3 (0.004, -0.004 to 0.012, P = 0.36). In year 1, the ILI had higher mean preference scores for all instruments. Thereafter, the increases remained significant only for FT and SF-6D, and the effects also become smaller. CONCLUSIONS: ILI aimed at reducing body weight among persons with overweight or obesity and type 2 diabetes improves preference-based HRQOL in the short term, but its long-term effect is unclear.

Text Message Support for Weight Loss in Patients With Prediabetes: A Randomized Clinical Trial.

OBJECTIVE: Although the benefits of in-person Diabetes Prevention Program (DPP) classes for diabetes prevention have been demonstrated in trials, effectiveness in clinical practice is limited by low participation rates. This study explores whether text message support enhances weight loss in patients offered DPP classes. RESEARCH DESIGN AND METHODS: English- and Spanish-speaking patients with prediabetes (n = 163) were randomized to the control group, which only received an invitation to DPP classes as defined by the Centers for Disease Control and Prevention, or to the text message-augmented intervention group, which also received text messages adapted from the DPP curriculum for 12 months. RESULTS: Mean weight decreased 0.6 pounds (95% CI -2.7 to 1.6) in the control group and 2.6 pounds (95% CI -5.5 to 0.2) in the intervention group (P value 0.05). Three percent weight loss was achieved by 21.5% of participants in the control group (95% CI 12.5-30.6), compared with 38.5% in the intervention group (95% CI 27.7-49.3) (absolute difference 17.0%; P value 0.02). Mean glycated hemoglobin (HbA1c) increased by 0.19% or 2.1 mmol/mol (95% CI -0.1 to 0.5%) and decreased by 0.09% or 1.0 mmol/mol (95% CI -0.2 to 0.0%) in the control group and intervention participants, respectively (absolute difference 0.28%; P value 0.07). Stratification by language demonstrated a significant treatment effect in Spanish speakers but not in English speakers. CONCLUSIONS: Text message support can lead to clinically significant weight loss in patients with prediabetes. Further study assessing effect by primary language and in an operational setting is warranted.

Patient Navigators Connecting Patients to Community Resources to Improve Diabetes Outcomes.

BACKGROUND: Despite the recognized importance of lifestyle modification in reducing risk of developing type 2 diabetes and in diabetes management, the use of available community resources by both patients and their primary care providers (PCPs) remains low. The patient navigator model, widely used in cancer care, may have the potential to link PCPs and community resources for reduction of risk and control of type 2 diabetes. In this study we tested the feasibility and acceptability of telephone-based nonprofessional patient navigation to promote linkages between the PCP office and community programs for patients with or at risk for diabetes. METHODS: This was a mixed-methods interventional prospective cohort study conducted between November 2012 and August 2013. We included adult patients with and at risk for type 2 diabetes from six primary care practices. Patient-level measures of glycemic control, diabetes care, and self-efficacy from medical records, and qualitative interview data on acceptability and feasibility, were used. RESULTS: A total of 179 patients participated in the study. Two patient navigators provided services over the phone, using motivational interviewing techniques. Patient navigators provided regular feedback to PCPs and followed up with the patients through phone calls. The patient navigators made 1028 calls, with an average of 6 calls per patient. At follow-up, reduction in HbA1c (7.8 ± 1.9% vs 7.2 ± 1.3%; P = .001) and improvement in patient self-efficacy (3.1 ± 0.8 vs 3.6 ± 0.7; P < .001) were observed. Qualitative analysis revealed uniformly positive feedback from providers and patients. CONCLUSIONS: The patient navigator model is a promising and acceptable strategy to link patient, PCP, and community resources for promoting lifestyle modification in people living with or at risk for type 2 diabetes.

A randomized clinical trial of a weight loss maintenance intervention in a primary care population.

OBJECTIVE: In-person weight loss maintenance visits have been shown to reduce weight regain after initial weight loss. This study examined, in a primary care population, whether in-person visits plus portion-controlled meals were more effective in reducing 12-month weight regain than mailed materials plus portion controlled meals. METHODS: Study participants (n = 106) received 6 months of intensive behavioral treatment. Participants who completed this phase (n = 84) were then randomized to continue monthly in-person visits for weight loss maintenance as well as telephone calls between visits ("intensified maintenance") or to receive materials by mail ("standard maintenance"). All participants had access to subsidized portion-controlled foods during the 6-month run-in and the 12 months of maintenance. The primary outcome was weight change during the 12 months after randomization. RESULTS: During months 0-12 after randomization, individuals assigned to standard maintenance regained 5.3% ± 0.8% of body weight, while those assigned to intensified maintenance regained 1.6% ± 1.2% of body weight. The difference between groups (3.7% ± 1.4%) was statistically significant (P = 0.01). CONCLUSIONS: In a primary care population, continued in-person visits during the weight loss maintenance phase led to greater weight loss than contact by mail.

Medication costs during an 18 month clinical trial of obesity treatment among patients encountered in primary care.

BACKGROUND: Weight loss often leads to reductions in medication costs, particularly for weight-related conditions. We aimed to evaluate changes in medication costs from an 18 month study of weight loss among patients recruited from primary care. METHODS: Study participants (n = 79, average age = 56.3; 75.7 % female) with average BMI of 39.5 kg/m(2), plus one co-morbid condition of either diabetes/pre-diabetes, hypertension, abnormal cholesterol, or sleep apnea, were recruited from 2 internal medicine practices. All participants received intensive behavioral and dietary treatment during months 0-6, including subsidized access to portion-controlled foods for weight loss. From months 7-18, all participants were offered continued access to subsidized foods, and half of participants were randomly assigned to continue in-person visits ("Intensified Maintenance"), while the other half received materials by mail or e-mail ("Standard Maintenance"). Medication costs were evaluated at months 0, 6, and 18. RESULTS: Participants assigned to Intensified Maintenance maintained nearly all their lost weight, whereas those assigned to Standard Maintenance regained weight. However, no significant differences in medication costs were observed within or between groups during the 18 months of the trial. A reduction of nearly $30 per month (12.9 %) was observed among all participants from month 0 to month 6 (active weight loss phase), but this difference did not reach statistical significance. CONCLUSIONS: A behavioral intervention that led to clinically significant weight loss did not lead to statistically significant reductions in medication costs. Substantial variability in medication costs and lack of a systematic approach by the study team to reduce medications may explain the lack of effect. TRIAL REGISTRATION: The trial was registered at (NCT01220089) on September 23, 2010.

Behavioral treatment of obesity in patients encountered in primary care settings: a systematic review.

IMPORTANCE: In 2011, the Centers for Medicare & Medicaid Services (CMS) approved intensive behavioral weight loss counseling for approximately 14 face-to-face, 10- to 15-minute sessions over 6 months for obese beneficiaries in primary care settings, when delivered by physicians and other CMS-defined primary care practitioners. OBJECTIVE: To conduct a systematic review of behavioral counseling for overweight and obese patients recruited from primary care, as delivered by primary care practitioners working alone or with trained interventionists (eg, medical assistants, registered dietitians), or by trained interventionists working independently. EVIDENCE REVIEW: We searched PubMed, CINAHL, and EMBASE for randomized controlled trials published between January 1980 and June 2014 that recruited overweight and obese patients from primary care; provided behavioral counseling (ie, diet, exercise, and behavioral therapy) for at least 3 months, with at least 6 months of postrandomization follow-up; included at least 15 participants per treatment group and objectively measured weights; and had a comparator, an intention-to-treat analysis, and attrition of less than 30% at 1 year or less than 40% at longer follow-up. FINDINGS: Review of 3304 abstracts yielded 12 trials, involving 3893 participants, that met inclusion-exclusion criteria and prespecified quality ratings. No studies were found in which primary care practitioners delivered counseling that followed the CMS guidelines. Mean 6-month weight changes from baseline in the intervention groups ranged from a loss of 0.3 kg to 6.6 kg. In the control group, mean change ranged from a gain of 0.9 kg to a loss of 2.0 kg. Weight loss in both groups generally declined with longer follow-up (12-24 months). Interventions that prescribed both reduced energy intake (eg, ≥ 500 kcal/d) and increased physical activity (eg, ≥150 minutes a week of walking), with traditional behavioral therapy, generally produced larger weight loss than interventions without all 3 specific components. In the former trials, more treatment sessions, delivered in person or by telephone by trained interventionists, were associated with greater mean weight loss and likelihood of patients losing 5% or more of baseline weight. CONCLUSIONS AND RELEVANCE: Intensive behavioral counseling can induce clinically meaningful weight loss, but there is little research on primary care practitioners providing such care. The present findings suggest that a range of trained interventionists, who deliver counseling in person or by telephone, could be considered for treating overweight or obesity in patients encountered in primary care settings.