A Model for Advancing Scale-Up of Complex Interventions for Vulnerable Populations: the ALACRITY Center for Health and Longevity in Mental Illness.

Many of the most pressing health issues in the USA and worldwide require complex, multi-faceted solutions. Delivery of such solutions is often complicated by the need to reach and engage vulnerable populations facing multiple barriers to care. While the fields of quality improvement and implementation science have made valuable gains in the development and spread of individual strategies to improve evidence-based practice delivery, models for coordinated deployment of numerous strategies to simultaneously implement multiple evidence-based interventions in vulnerable populations are lacking. In this Perspective, we describe a model for this type of comprehensive research-practice translation effort: the Johns Hopkins ALACRITY Center for Health and Longevity in Mental Illness, which is focused on reducing premature mortality in the population with serious mental illness. We describe the Center's conceptual framework, which is built upon an integrated set of quality improvement and implementation science frameworks, provide an overview of the Center's organizational structure and core research-practice translation activities, and discuss our vision for how the Center may evolve over time. Lessons learned from this Center's efforts could inform models to address other critical health issues in vulnerable populations that require multi-component solutions at the policy, system, provider, and patient levels.

Behavioral Weight Loss Programs for Cancer Survivors Throughout Maryland: Protocol for a Pragmatic Trial and Participant Characteristics.

BACKGROUND: Clinical trials examining lifestyle interventions for weight loss in cancer survivors have been demonstrated to be safe, feasible, and effective. However, scalable weight loss programs are needed to support their widespread implementation. The ASPIRE trial was designed to evaluate real-world, lifestyle-based, weight loss programs for cancer survivors throughout Maryland. OBJECTIVE: The objectives of this protocol paper are to describe the design of a nonrandomized pragmatic trial, study recruitment, and baseline characteristics of participants. METHODS: Participants were aged ≥18 years, residing in Maryland, with a BMI ≥25 kg/m2, who reported a diagnosis of a malignant solid tumor, completed curative treatment, and had no ongoing or planned cancer treatment. Enrollment criteria were minimized to increase generalizability. The primary recruitment source was the Johns Hopkins Health System electronic health records (EHRs). Participants selected 1 of 3 remotely delivered weight loss programs: self-directed, app-supported, or coach-supported program. RESULTS: Participants were recruited across all 5 geographic regions of Maryland. Targeted invitations using EHRs accounted for 287 (84.4%) of the 340 participants enrolled. Of the 5644 patients invited through EHR, 5.1% (287/5644) enrolled. Participants had a mean age of 60.7 (SD 10.8) years, 74.7% (254/340) were female, 55.9% (190/340) identified as non-Hispanic Black, 58.5% (199/340) had a bachelor's degree, and the average BMI was 34.1 kg/m2 (SD 5.9 kg/m2). The most common types of cancers were breast (168/340, 49.4%), prostate (72/340, 21.2%), and thyroid (39/340, 8.5%). The self-directed weight loss program (n=91) included 25 participants who agreed to provide weights through a study scale; the app-supported program (n=142) included 108 individuals who agreed to provide their weight measurements; and the coach-supported weight loss program included 107 participants. We anticipate final analysis will take place in the fall of 2024. CONCLUSIONS: Using EHR-based recruitment efforts, this study took a pragmatic approach to reach and enroll cancer survivors into remotely delivered weight loss programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT04534309; https://clinicaltrials.gov/study/NCT04534309. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54126.

Implementing an evidence-based behavioral weight-loss program in community mental health centers: A randomized pilot study.

Background: Obesity is a leading cause of preventable death among individuals with serious mental illness (SMI). A prior randomized controlled trial demonstrated the efficacy of a lifestyle style intervention tailored to this population; however, such interventions need to be adapted and tested for real-world settings. Aims: This study evaluated implementation interventions to support community mental health program staff to deliver an evidence-based lifestyle intervention to clients with obesity and SMI. Materials & Methods: In this cluster-randomized pilot trial, the standard arm combined multimodal training with organizational strategy meetings and the enhanced arm included all standard strategies plus performance coaching. Staff-coaches delivered a 6-month group-based lifestyle intervention to clients with SMI. Primary outcomes were changes in staff knowledge, self-efficacy, and fidelity scores for lifestyle intervention delivery. Linear mixed-effects modeling was used to analyze outcomes, addressing within-site clustering and within-participant longitudinal correlation of outcomes. Results: Three sites were in the standard arm (7 staff-coaches); 5 sites in the enhanced arm (11 staff-coaches). All sites delivered all 26 modules of the lifestyle intervention. Staff-coaches highly rated the training strategy's acceptability, feasibility and appropriateness. Overall, mean knowledge score significantly increased pre-post by 5.5 (95% CI: 3.9, 7.1) and self-efficacy was unchanged; neither significantly differed between arms. Fidelity ratings remained stable over time and did not differ between arms. Clients with SMI achieved a mean 6-month weight loss of 3.8 kg (95% CI: 1.6, 6.1). Conclusions: Mental health staff delivering a lifestyle intervention was feasible using multicomponent implementation interventions, and preliminary results show weight reduction among clients with SMI. The addition of performance coaching did not significantly change outcomes. Future studies are needed to definitively determine the effect on client health outcomes.

Comparing Implementation Strategies for an Evidence-Based Weight Management Program Delivered in Community Mental Health Programs: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Among people with serious mental illness (SMI), obesity contributes to increased cardiovascular disease (CVD) risk. The Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) randomized controlled trial (RCT) demonstrated that a behavioral intervention tailored to the needs of individuals with SMI results in clinically significant weight loss. While the research team delivered the ACHIEVE intervention in the trial, community mental health program staff are needed to deliver sessions to make scale-up feasible. Therefore, we adapted the ACHIEVE-Dissemination (ACHIEVE-D) curriculum to ease adoption and implementation in this setting. Designing and testing of implementation strategies is now needed to understand how to support ACHIEVE-D delivery by community mental health program staff coaches. OBJECTIVE: This study aims to conduct a pilot trial evaluating standard and enhanced implementation interventions to support the delivery of ACHIEVE-D in community mental health programs by examining effects on staff coaches' knowledge, self-efficacy, and delivery fidelity of the curriculum. We will also examine the effects on outcomes among individuals with SMI taking part in the curriculum. METHODS: The trial will be a cluster-randomized, 2-arm parallel pilot RCT comparing standard and enhanced implementation intervention at 6 months within community mental health programs. We will randomly assign programs to either the standard or enhanced implementation interventions. The standard intervention will combine multimodal training for coaches (real-time initial training via videoconference, ongoing virtual training, and web-based avatar-assisted motivational interviewing practice) with organizational strategy meetings to garner leadership support for implementation. The enhanced intervention will include all standard strategies, and the coaches will receive performance coaching. At each program, we will enroll staff to participate as coaches and clients with SMI to participate in the curriculum. Coaches will deliver the ACHIEVE-D curriculum to the clients with SMI. Primary outcomes will be coaches' knowledge, self-efficacy, and fidelity to the ACHIEVE-D curriculum. We will also examine the acceptability, feasibility, and appropriateness of ACHIEVE-D and the implementation strategies. Secondary outcomes among individuals with SMI will be weight and self-reported lifestyle behaviors. RESULTS: Data collection started in March 2021, with completion estimated in March 2023. We recruited 9 sites and a total of 20 staff coaches and 72 clients with SMI. The expected start of data analyses will occur in March 2023, with primary results submitted for publication in April 2023. CONCLUSIONS: Community mental health programs may be an ideal setting for implementing an evidence-based weight management curriculum for individuals with SMI. This pilot study will contribute knowledge about implementation strategies to support the community-based delivery of such programs, which may inform future research that definitively tests the implementation and dissemination of behavioral weight management programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT03454997; https://clinicaltrials.gov/ct2/show/NCT03454997. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45802.

Scaling a behavioral weight-loss intervention for individuals with serious mental illness using the enhanced replicating effective programs framework: A preconditions phase proof-of-concept study.

Background: Given the obesity's high prevalence among individuals with serious mental illness (SMI), translating weight-loss interventions with demonstrated effectiveness is needed. This study describes the initial translation phase of such an intervention using the Enhanced Replicating Effective Programs (REP) Framework for delivery by mental health program staff. Methods: The Achieving Healthy Lifestyles in Psychiatric Rehabilitation (Achieving Healthy Lifestyles in Psychiatric Rehabilitation) trial intervention was preliminarily adapted to create the ACHIEVE-Dissemination (ACHIEVE-D) curriculum. A treatment-only study was conducted to rapidly evaluate the curriculum using a mixed-methods approach including surveys and focus groups. A study coach delivered an abbreviated curriculum to individuals with SMI from a single psychiatric program. Among all participants with SMI (n = 17), outcomes were attendance and satisfaction; 14 participated in a focus group. The program staff observed curriculum delivery and participated in a focus group (n = 3). Results: Overall, 23 group sessions were delivered. Median attendance was 78.6% across participants with SMI; 92.9% would recommend ACHIEVE-D to others. The staff found the curriculum acceptable, particularly its structured nature, inclusion of weight management and exercise, and integrated goal setting and tracking. These improvements recommended by participants and/or staff were to assess participant readiness-to-change prior to enrollment, change the frequency of weigh-ins, and train staff coaches on anticipated challenges (e.g., exercise engagement, weight fluctuations). Conclusions: During this first REP phase, individuals with SMI and program staff were satisfied with ACHIEVE-D. Additional refinements will aid future implementation and improve participant experience.

Effect of a Tobacco Cessation Intervention Incorporating Weight Management for Adults With Serious Mental Illness: A Randomized Clinical Trial.

Importance: Tobacco smoking drives markedly elevated cardiovascular disease risk and preventable death in persons with serious mental illness, and these risks are compounded by the high prevalence of overweight/obesity that smoking cessation can exacerbate. Guideline-concordant combined pharmacotherapy and behavioral smoking cessation treatment improves abstinence but is not routinely offered in community settings, particularly to those not seeking to quit smoking immediately. Objective: To determine the effectiveness of an 18-month pharmacotherapy and behavioral smoking cessation intervention incorporating weight management and support for physical activity in adults with serious mental illness interested in quitting smoking within 1 or 6 months. Design, Setting, and Participants: This was a randomized clinical trial conducted from July 25, 2016, to March 20, 2020, at 4 community health programs. Adults with serious mental illness who smoked tobacco daily were included in the study. Participants were randomly assigned to intervention or control, stratified by willingness to try to quit immediately (within 1 month) or within 6 months. Assessors were masked to group assignment. Interventions: Pharmacotherapy, primarily varenicline, dual-form nicotine replacement, or their combination; tailored individual and group counseling for motivational enhancement; smoking cessation and relapse prevention; weight management counseling; and support for physical activity. Controls received quitline referrals. Main Outcome and Measures: The primary outcome was biochemically validated, 7-day point-prevalence tobacco abstinence at 18 months. Results: Of the 298 individuals screened for study inclusion, 192 enrolled (mean [SD] age, 49.6 [11.7] years; 97 women [50.5%]) and were randomly assigned to intervention (97 [50.5%]) or control (95 [49.5%]) groups. Participants self-identified with the following race and ethnicity categories: 93 Black or African American (48.4%), 6 Hispanic or Latino (3.1%), 90 White (46.9%), and 9 other (4.7%). A total of 82 participants (42.7%) had a schizophrenia spectrum disorder, 62 (32.3%) had bipolar disorder, and 48 (25.0%) had major depressive disorder; 119 participants (62%) reported interest in quitting immediately (within 1 month). Primary outcome data were collected in 183 participants (95.3%). At 18 months, 26.4% of participants (observed count, 27 of 97 [27.8%]) in the intervention group and 5.7% of participants (observed count, 6 of 95 [6.3%]) in the control group achieved abstinence (adjusted odds ratio [OR], 5.9; 95% CI, 2.3-15.4; P < .001). Readiness to quit within 1 month did not statistically significantly modify the intervention's effect on abstinence. The intervention group did not have significantly greater weight gain than the control group (mean weight change difference, 1.6 kg; 95% CI, -1.5 to 4.7 kg). Conclusions and Relevance: Findings of this randomized clinical trial showed that in persons with serious mental illness who are interested in quitting smoking within 6 months, an 18-month intervention with first-line pharmacotherapy and tailored behavioral support for smoking cessation and weight management increased tobacco abstinence without significant weight gain. Trial Registration: ClinicalTrials.gov Identifier: NCT02424188.

A Community-Engaged Process for Adapting a Cardiovascular Health Intervention for Persons with Serious Mental Illness.

Introduction: People with serious mental illness experience grave disparities in cardiovascular disease risk factors. To promote scale-up of effective cardiovascular disease risk reduction interventions from clinical trials, it is important to involve end-users in adapting interventions to fit the needs of community-based settings. Objective: We describe a novel, theory-informed process of garnering community input to adapt IDEAL Goals, an evidence-based intervention for improving cardiovascular disease risk factors in persons with serious mental illness. Setting: Outpatient community mental health programs in Maryland and Michigan implementing behavioral health homes, which provide enhanced support to people living with both physical and mental illnesses. Participants: Clinicians, frontline staff, and administrators from community mental health organizations and persons with serious mental illness. Methods: Our approach to community engagement is based on the Replicating Effective Programs (REP) framework. During the REP preimplementation phase, we used 2 community engagement activities: (1) a "needs assessment" to identify anticipated implementation barriers and facilitators, and (2) "community working groups" to collaboratively engage with end-users in adapting the intervention and implementation strategies. Main Findings: We used the Stakeholder Engagement Reporting Questionnaire to describe our processes for conducting a needs assessment, involving site-level surveys (N=26) and individual interviews (N=94), and convening a series of community working groups with clinicians and staff (mean, 24 per meeting) and persons with serious mental illness (mean, 8 per meeting). Conclusions: By specifying the nature and extent of our community engagement activities, we aim to contribute to the evidence base of how to better integrate and measure community-engaged processes in the adaptation of evidence-based interventions.

Physical Activity Levels and Screen Time among Youth with Overweight/Obesity Using Mental Health Services.

Youth with mental illness have higher levels of obesity than children in the general population. Both regular physical activity and limited screen time have been recommended to reduce and prevent childhood obesity. This study examines accelerometer-based moderate-vigorous physical activity (MVPA) and screen time among youth with overweight/obesity issues who are receiving mental health care. This study looked at a 12-month weight management randomized clinical trial for overweight/obese youth aged 8-18 years who are receiving mental health services. At baseline, MVPA was assessed using accelerometers, and screen time was self-reported. Among 100 youth, 43% were female, 44% were Black, and 48% were <13 years old. In an adjusted general linear model, higher levels of MVPA were associated with the younger age group (p = 0.012), male participants (p = 0.013), and lower BMI z-scores (p = 0.014). In a separate model, higher screen time was associated with participants who were Black (p = 0.007). Achieving optimal cardiovascular health at the population level requires an understanding of the groups that are most in need of additional assistance. These data reinforce that targeted lifestyle approaches to promote increased physical activity and decreased screen time among overweight/obese youth using mental health services may need additional tailoring for sex, age, and race subgroups.

Determining Predictors of Weight Loss in a Behavioral Intervention: A Case Study in the Use of Lasso Regression.

OBJECTIVE: This study investigates predictors of weight loss among individuals with serious mental illness participating in an 18-month behavioral weight loss intervention, using Lasso regression to select the most powerful predictors. METHODS: Data were analyzed from the intervention group of the ACHIEVE trial, an 18-month behavioral weight loss intervention in adults with serious mental illness. Lasso regression was employed to identify predictors of at least five-pound weight loss across the intervention time span. Once predictors were identified, classification trees were created to show examples of how to classify participants into having likely outcomes based on characteristics at baseline and during the intervention. RESULTS: The analyzed sample contained 137 participants. Seventy-one (51.8%) individuals had a net weight loss of at least five pounds from baseline to 18 months. The Lasso regression selected weight loss from baseline to 6 months as a primary predictor of at least five pound 18-month weight loss, with a standardized coefficient of 0.51 (95% CI: -0.37, 1.40). Three other variables were also selected in the regression but added minimal predictive ability. CONCLUSIONS: The analyses in this paper demonstrate the importance of tracking weight loss incrementally during an intervention as an indicator for overall weight loss, as well as the challenges in predicting long-term weight loss with other variables commonly available in clinical trials. The methods used in this paper also exemplify how to effectively analyze a clinical trial dataset containing many variables and identify factors related to desired outcomes.

Evaluation of a Video-Assisted Patient Education Program to Reduce Blood Pressure Delivered Through the Electronic Medical Record: Results of a Quality Improvement Project.

BACKGROUND: Low-cost, automated interventions that increase knowledge and skills around diet and lifestyle modifications are recommended for cardiovascular disease risk reduction. METHODS: We initiated a quality improvement program to assess the impact of a web-based diet and lifestyle intervention utilizing short animated videos in adults with high blood pressure (BP) at a primary care clinic in Saudi Arabia. We enrolled adults with elevated BP, not on BP medications, who were identified using the electronic medical record. We delivered a web-linked diet and lifestyle intervention using animated videos covering diet and lifestyle topics. Videos and reminders were sent weekly for 5 weeks. Outcomes were proportion who engaged in the program, returned for a repeat BP within 3 months, and change in BP. RESULTS: We enrolled 269 adult participants, with a mean (SD) age of 41.6 (12.4) years; 77% were male. At the conclusion of the pilot, we demonstrated a high level of engagement: overall, 69% of materials were viewed and 67% of patients returned for BP. Patients who returned had a mean (SD) baseline systolic BP of 138.0 (7.2) mm Hg and a large mean reduction in systolic BP from baseline, -10.5 mm Hg (12.4; P < 0.001). CONCLUSIONS: Overall, the feasibility of a video-assisted, web-based, diet and lifestyle intervention as a support tool for hypertension management demonstrated a high participation rate and a high return rate for reassessment of BP. These findings suggest that this low-cost, automated intervention may have a great potential as a scalable tool for blood pressure management. However, randomized trials to understanding the effectiveness of the support tools are needed.

Effects of Behavioral Weight Loss and Metformin on IGFs in Cancer Survivors: A Randomized Trial.

CONTEXT: Higher levels of insulin-like growth factor-1 (IGF-1) are associated with increased risk of cancers and higher mortality. Therapies that reduce IGF-1 have considerable appeal as means to prevent recurrence. DESIGN: Randomized, 3-parallel-arm controlled clinical trial. INTERVENTIONS AND OUTCOMES: Cancer survivors with overweight or obesity were randomized to (1) self-directed weight loss (comparison), (2) coach-directed weight loss, or (3) metformin treatment. Main outcomes were changes in IGF-1 and IGF-1:IGFBP3 molar ratio at 6 months. The trial duration was 12 months. RESULTS: Of the 121 randomized participants, 79% were women, 46% were African Americans, and the mean age was 60 years. At baseline, the average body mass index was 35 kg/m2; mean IGF-1 was 72.9 (SD, 21.7) ng/mL; and mean IGF1:IGFBP3 molar ratio was 0.17 (SD, 0.05). At 6 months, weight changes were -1.0% (P = 0.07), -4.2% (P < 0.0001), and -2.8% (P < 0.0001) in self-directed, coach-directed, and metformin groups, respectively. Compared with the self-directed group, participants in metformin had significant decreases on IGF-1 (mean difference in change: -5.50 ng/mL, P = 0.02) and IGF1:IGFBP3 molar ratio (mean difference in change: -0.0119, P = 0.011) at 3 months. The significant decrease of IGF-1 remained in participants with obesity at 6 months (mean difference in change: -7.2 ng/mL; 95% CI: -13.3 to -1.1), but not in participants with overweight (P for interaction = 0.045). There were no significant differences in changes between the coach-directed and self-directed groups. There were no differences in outcomes at 12 months. CONCLUSIONS: In cancer survivors with obesity, metformin may have a short-term effect on IGF-1 reduction that wanes over time.

Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial.

BACKGROUND: Overweight and obesity are highly prevalent among persons with serious mental illness. These conditions likely contribute to premature cardiovascular disease and a 20 to 30 percent shortened life expectancy in this vulnerable population. Persons with serious mental illness need effective, appropriately tailored behavioral interventions to achieve and maintain weight loss. Psychiatric rehabilitation day programs provide logical intervention settings because mental health consumers often attend regularly and exercise can take place on-site. This paper describes the Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE). The goal of the study is to determine the effectiveness of a behavioral weight loss intervention among persons with serious mental illness that attend psychiatric rehabilitation programs. Participants randomized to the intervention arm of the study are hypothesized to have greater weight loss than the control group. METHODS/DESIGN: A targeted 320 men and women with serious mental illness and overweight or obesity (body mass index ≥ 25.0 kg/m2) will be recruited from 10 psychiatric rehabilitation programs across Maryland. The core design is a randomized, two-arm, parallel, multi-site clinical trial to compare the effectiveness of an 18-month behavioral weight loss intervention to usual care. Active intervention participants receive weight management sessions and physical activity classes on-site led by study interventionists. The intervention incorporates cognitive adaptations for persons with serious mental illness attending psychiatric rehabilitation programs. The initial intensive intervention period is six months, followed by a twelve-month maintenance period in which trained rehabilitation program staff assume responsibility for delivering parts of the intervention. Primary outcomes are weight loss at six and 18 months. DISCUSSION: Evidence-based approaches to the high burden of obesity and cardiovascular disease risk in person with serious mental illness are urgently needed. The ACHIEVE Trial is tailored to persons with serious mental illness in community settings. This multi-site randomized clinical trial will provide a rigorous evaluation of a practical behavioral intervention designed to accomplish and sustain weight loss in persons with serious mental illness.

Associations of internet website use with weight change in a long-term weight loss maintenance program.

BACKGROUND: The Weight Loss Maintenance Trial (WLM) compared two long-term weight-maintenance interventions, a personal contact arm and an Internet arm, with a no-treatment control after an initial six-month Phase I weight loss program. The Internet arm focused on use of an interactive website for support of long-term weight maintenance. There is limited information about patterns of website use and specific components of an interactive website that might help promote maintenance of weight loss. OBJECTIVE: This paper presents a secondary analysis of the subset of participants in the Internet arm and focuses on website use patterns and features associated with long-term weight maintenance. METHODS: Adults at risk for cardiovascular disease (CVD) who lost at least 4 kilograms in an initial 20-week group-based, behavioral weight-loss program were trained to use an interactive website for weight loss maintenance. Of the 348 participants, 37% were male and 38% were African American. Mean weight loss was 8.6 kilograms. Participants were encouraged to log in at least weekly and enter a current weight for the 30-month study period. The website contained features that encouraged setting short-term goals, creating action plans, and reinforcing self-management habits. The website also included motivational modules, daily tips, and tailored messages. Based on log-in and weight-entry frequency, we divided participants into three website use categories: consistent, some, and minimal. RESULTS: Participants in the consistent user group (n = 212) were more likely to be older (P = .002), other than African American (P = .02), and more educated (P = .01). While there was no significant difference between website use categories in the amount of Phase I change in body weight (P = .45) or income (P = .78), minimal website users (n = 75) were significantly more likely to have attended fewer Phase I sessions (P = .001) and had a higher initial body mass index (BMI) (P < .001). After adjusting for baseline characteristics including initial BMI, variables most associated with less weight regain included: number of log-ins (P = .001), minutes on the website (P < .001), number of weight entries (P = .002), number of exercise entries (P < .001), and sessions with additional use of website features after weight entry (P = .002). CONCLUSION: Participants defined as consistent website users of an interactive behavioral website designed to promote maintenance of weight loss were more successful at maintaining long-term weight loss. TRIAL REGISTRATION: NCT00054925; http://clinicaltrials.gov/ct2/show/NCT00054925 (Archived by WebCite at http://www.webcitation.org/5rC7523ue).

Weight management program for first responders: Feasibility study and lessons learned.

BACKGROUND: Overweight and obesity are significant concerns for first responders (firefighters and emergency medical service providers). OBJECTIVE: This pilot study examines the feasibility of a weight loss program for career first responders. METHODS: Participants were career first responders with BMI≥30 and interest in losing weight. Baseline height, weight, and body composition using dual x-ray absorptiometry, Pittsburgh Sleep Quality Index (PSQI), and a Functional Movement Screen (FMS) with follow-up weight and body composition were assessed. A 10-week weight loss program used evidence-based lifestyle goals (encouraged increasing activity levels, using tailored calorie goals, following the DASH diet, tracking with a phone app) and weekly in-person sessions with a student coach-in-training who reviewed weight and tracking information. RESULTS: Participants (N = 10) were 39.0±9.9 years old with a BMI of 35.6±4.7 kg/m2. There were significant reductions in weight -4.8±2.3 kg and percent body fat -3.9±1.7%. All participants had a PSQI score >5 indicating poor quality of sleep. Nine participants had FMS scores ≤14 indicating increased risk of injury. CONCLUSION: The use of commercially available apps with support from a student coach-in-training and evidence-based weight loss recommendations is a feasible approach to support career firefighters in their weight loss efforts.

Potassium-Enriched Salt Substitutes as a Means to Lower Blood Pressure: Benefits and Risks.

Use of salt substitutes containing potassium chloride is a potential strategy to reduce sodium intake, increase potassium intake, and thereby lower blood pressure and prevent the adverse consequences of high blood pressure. In this review, we describe the rationale for using potassium-enriched salt substitutes, summarize current evidence on the benefits and risks of potassium-enriched salt substitutes and discuss the implications of using potassium-enriched salt substitutes as a strategy to lower blood pressure. A benefit of salt substitutes that contain potassium chloride is the expected reduction in dietary sodium intake at the population level because of reformulation of manufactured foods or replacement of sodium chloride added to food during home cooking or at the dining table. There is empirical evidence that replacement of sodium chloride with potassium-enriched salt substitutes lowers systolic and diastolic blood pressure (average net Δ [95% CI] in mm Hg: -5.58 [-7.08 to -4.09] and -2.88 [-3.93 to -1.83], respectively). The risks of potassium-enriched salt substitutes include a possible increased risk of hyperkalemia and its principal adverse consequences: arrhythmias and sudden cardiac death, especially in people with conditions that impair potassium excretion such as chronic kidney disease. There is insufficient evidence regarding the effects of potassium-enriched salt substitutes on the occurrence of hyperkalemia. There is a need for additional empirical research on the effect of increasing dietary potassium and potassium-enriched salt substitutes on serum potassium levels and the risk of hyperkalemia, as well as for robust estimation of the population-wide impact of replacing sodium chloride with potassium-enriched salt substitutes.

Cost of behavioral weight loss programs implemented in clinical practice: The POWER trial at Johns Hopkins.

Obesity presents an important public health problem that affects more than a third of the U.S. adult population and that is associated with increased morbidity, mortality, and costs. Previously, we documented that two primary care-based weight loss interventions were clinically effective. To encourage the implementation of and reimbursement for these interventions, we evaluated their relative cost-effectiveness. We performed a cost analysis of the Practice-based Opportunities for Weight Reduction (POWER) trial, a three-arm trial that enrolled 415 patients with obesity from six primary care practices. Trial participants were randomized to a control arm, an in-person support intervention, or a remote support intervention; in the two intervention arms, behavioral interventions were delivered over 24 months, in two phases. Weight loss was measured at 6, 12, and 24 months. Using timesheets and empirical data, we evaluated the cost of the in-person and remote support interventions from the perspective of a health care system delivering the interventions. A univariate sensitivity analysis was conducted to evaluate uncertainty around model assumptions. All comparisons were tested using independent t-tests. Cost of the in-person intervention was higher at 6 months ($113 per participant per month and $117 per kg lost) than the remote support intervention ($101 per participant per month and $99 per kg lost; p < .001). Costs were also higher for the in-person support intervention at 24 months ($73 per participant per month and $342 per kg lost) than for the remote support intervention ($53 per participant per month and $275 per kg lost; p < .001). In the sensitivity analyses, cost ranged from $274/kg lost to $456/kg lost for the in-person support intervention and from $218/kg to $367/kg lost for the remote support intervention. A primary care weight loss intervention administered remotely was relatively more cost-effective than an in-person intervention. Expanding the scope of reimbursable programs to include other cost-effective interventions could help ensure that a broader range of patients receive the type of support needed.

Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness: A Randomized Clinical Trial.

Importance: Persons with serious mental illness have a cardiovascular disease mortality rate more than twice that of the overall population. Meaningful cardiovascular risk reduction requires targeted efforts in this population, who often have psychiatric symptoms and cognitive impairment. Objective: To determine the effectiveness of an 18-month multifaceted intervention incorporating behavioral counseling, care coordination, and care management for overall cardiovascular risk reduction in adults with serious mental illness. Design, Setting, and Participants: This randomized clinical trial was conducted from December 2013 to November 2018 at 4 community mental health outpatient programs in Maryland. The study recruited adults with at least 1 cardiovascular disease risk factor (hypertension, diabetes, dyslipidemia, current tobacco smoking, and/or overweight or obesity) attending the mental health programs. Of 398 participants screened, 269 were randomized to intervention (132 participants) or control (137 participants). Data collection staff were blinded to group assignment. Data were analyzed on the principle of intention to treat, and data analysis was performed from November 2018 to March 2019. Interventions: A health coach and nurse provided individually tailored cardiovascular disease risk reduction behavioral counseling, collaborated with physicians to implement appropriate risk factor management, and coordinated with mental health staff to encourage attainment of health goals. Programs offered physical activity classes and received consultation on serving healthier meals; intervention and control participants were exposed to these environmental changes. Main Outcomes and Measures: The primary outcome was the change in the risk of cardiovascular disease from the global Framingham Risk Score (FRS), which estimates the 10-year probability of a cardiovascular disease event, from baseline to 18 months, expressed as percentage change for intervention compared with control. Results: Of 269 participants randomized (mean [SD] age, 48.8 [11.9] years; 128 men [47.6%]), 159 (59.1%) had a diagnosis of schizophrenia or schizoaffective disorder, 67 (24.9%) had bipolar disorder, and 38 (14.1%) had major depressive disorder. At 18 months, the primary outcome, FRS, was obtained for 256 participants (95.2%). The mean (SD) baseline FRS was 11.5% (11.5%) (median, 8.6%; interquartile range, 3.9%-16.0%) in the intervention group and 12.7% (12.7%) (median, 9.1%; interquartile range, 4.0%-16.7%) in the control group. At 18 months, the mean (SD) FRS was 9.9% (10.2%) (median, 7.7%; interquartile range, 3.1%-12.0%) in the intervention group and 12.3% (12.0%) (median, 9.7%; interquartile range, 4.0%-15.9%) in the control group. Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months. Conclusions and Relevance: An 18-month behavioral counseling, care coordination, and care management intervention statistically significantly reduced overall cardiovascular disease risk in adults with serious mental illness. This intervention provides the means to substantially reduce health disparities in this high-risk population. Trial Registration: ClinicalTrials.gov Identifier: NCT02127671.

Effect of a Behavioral Weight Loss Intervention in People With Serious Mental Illness and Diabetes.

OBJECTIVE: Given the high prevalence of obesity and diabetes in patients with serious mental illness (SMI) and the lack of evidence on the effects of weight loss programs in SMI patients with diabetes, we evaluated the effectiveness of a behavioral weight loss intervention among SMI participants with and without diabetes. RESEARCH DESIGN AND METHODS: Using data from ACHIEVE, a randomized controlled trial to evaluate the effects of a behavioral weight loss intervention among overweight/obese people with SMI, we assessed and compared weight change from baseline to 18 months in participants with and without diabetes using a longitudinal mixed-effects model. RESULTS: Of the 291 trial participants, 82 (28.2%) participants had diabetes (34 and 48 in intervention and control groups, respectively) at baseline. Participants with diabetes were more likely to be taking antipsychotics (31.7% vs. 18.7%, P = 0.02). At 18 months, participants in the control group with diabetes lost 1.2 lb (0.6%) of body weight compared with 0.8 lb (0.7%) among those without diabetes. In the intervention group, participants with diabetes lost 13.7 lb (6.6%) of their initial body weight compared with 5.4 lb (2.9%) for those without diabetes. Corresponding net effects (intervention minus control) were 4.6 lb (2.2%) and 12.5 lb (6.0%) net weight reduction over 18 months in the no diabetes and the diabetes subgroups, respectively. However, the between-group difference in intervention effects was statistically nonsignificant (absolute weight change: P-interaction = 0.08; % weight change: P-interaction = 0.10). CONCLUSIONS: A behavioral weight loss intervention is effective among overweight and obese individuals with SMI regardless of their diabetes status.

Need for Cardiovascular Risk Reduction in Persons With Serious Mental Illness: Design of a Comprehensive Intervention.

Persons with serious mental illness (SMI) comprise a high-risk group for cardiovascular disease (CVD)-related mortality with rates at least twice those of the overall US. Potentially modifiable CVD risk behaviors (tobacco smoking, obesity, physical inactivity, unhealthy diet) and risk factors (hypertension, diabetes, dyslipidemia) are all markedly elevated in persons with SMI. Evaluations of programs implementing integrated medical care into specialty mental health settings have not shown meaningful effects on CVD risk factor reduction. Rigorously tested, innovative interventions are needed to address the large burden of CVD risk in populations with SMI. In this article, we describe the design of a comprehensive 18-month intervention to decrease CVD risk that we are studying in a randomized clinical trial in a community mental health organization with psychiatric rehabilitation programs. The individual-level intervention incorporated health behavior coaching and care coordination/care management to address all seven CVD risk behaviors and risk factors, and is delivered by a health coach and nurse. If successful, the intervention could be adopted within current integrated care models and significantly improve the physical health of persons with SMI.

A cost analysis of implementing a behavioral weight loss intervention in community mental health settings: Results from the ACHIEVE trial.

OBJECTIVE: In the ACHIEVE randomized controlled trial, an 18-month behavioral intervention accomplished weight loss in persons with serious mental illness who attended community psychiatric rehabilitation programs. This analysis estimates costs for delivering the intervention during the study. It also estimates expected costs to implement the intervention more widely in a range of community mental health programs. METHODS: Using empirical data, costs were calculated from the perspective of a community psychiatric rehabilitation program delivering the intervention. Personnel and travel costs were calculated using time sheet data. Rent and supply costs were calculated using rent per square foot and intervention records. A univariate sensitivity analysis and an expert-informed sensitivity analysis were conducted. RESULTS: With 144 participants receiving the intervention and a mean weight loss of 3.4 kg, costs of $95 per participant per month and $501 per kilogram lost in the trial were calculated. In univariate sensitivity analysis, costs ranged from $402 to $725 per kilogram lost. Through expert-informed sensitivity analysis, it was estimated that rehabilitation programs could implement the intervention for $68 to $85 per client per month. CONCLUSIONS: Costs of implementing the ACHIEVE intervention were in the range of other intensive behavioral weight loss interventions. Wider implementation of efficacious lifestyle interventions in community mental health settings will require adequate funding mechanisms.