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.

Differences in weight-loss outcomes among race-gender subgroups by behavioural intervention delivery mode: An analysis of the POWER trial.

Prior in-person behavioural intervention studies have documented differential weight loss between men and women and by race, with Black women receiving the least benefit. Remotely delivered interventions are now commonplace, but few studies have compared outcomes by race-gender groups and delivery modality. We conducted a secondary analysis of POWER, a randomized trial (NCT00783315) designed to determine the effectiveness of 2 active, lifestyle-based, weight loss interventions (remote vs. in-person) compared to a control group. Participants with obesity and at least one cardiovascular disease risk factor (N = 415) were recruited in the Baltimore, MD area. Data from 233 white and 170 Black individuals were used for this analysis. Following an intention-to-treat approach, we compared the mean percent weight loss at 24 months by race-gender subgroups using repeated-measures, mixed-effects models. Everyone lost weight in the active interventions however, weight loss differed by race and gender. white and Black men had similar results for both interventions (white: in-person (-7.6%) remote (-7.4%); Black: in-person (-4.7%) remote (-4.4%)). In contrast, white women lost more weight with the in-person intervention (in-person (-7.2%) compared to the remote (-4.4%)), whereas Black women lost less weight in the in-person group compared to the remote intervention at 24 months (-2.0% vs. -3.0%, respectively; p for interaction <.001). We found differences between the effectiveness of the 2 weight loss interventions-in-person or remote-in white and Black women at 24 months. Future studies should consider intervention modality when designing weight loss interventions for women.

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.

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.

Promoting Evidence-Based Tobacco Cessation Treatment in Community Mental Health Clinics: Protocol for a Prepost Intervention Study.

BACKGROUND: Tobacco smoking is highly prevalent among persons with serious mental illness (SMI) and is the largest contributor to premature mortality in this population. Evidence-based smoking cessation therapy with medications and behavioral counseling is effective for persons with SMI, but few receive this treatment. Mental health providers have extensive experience working with clients with SMI and frequent treatment contacts, making them well positioned to deliver smoking cessation treatment. However, few mental health providers feel adequately trained to deliver this treatment, and many providers believe that smokers with SMI are not interested in quitting or have concerns about the safety of smoking cessation pharmacotherapy, despite substantial evidence to the contrary. OBJECTIVE: We present the protocol for the pilot "IMPACT" (Implementing Action for Tobacco Smoking Cessation Treatment) study, which aims to pilot test a multicomponent implementation intervention to increase the delivery of evidence-based tobacco smoking cessation treatment in community mental health clinics. METHODS: We are using a prepost observational design to examine the effects of an implementation intervention designed to improve mental health providers' delivery of the following four evidence-based practices related to smoking cessation treatment: (1) assessment of smoking status, (2) assessment of willingness to quit, (3) behavioral counseling, and (4) pharmacotherapy prescribing. To overcome key barriers related to providers' knowledge and self-efficacy of smoking cessation treatment, the study will leverage implementation strategies including (1) real-time and web-based training for mental health providers about evidence-based smoking cessation treatment and motivational interviewing, including an avatar practice module; (2) a tobacco smoking treatment protocol; (3) expert consultation; (4) coaching; and (5) organizational strategy meetings. We will use surveys and in-depth interviews to assess the implementation intervention's effects on providers' knowledge and self-efficacy, the mechanisms of change targeted by the intervention, as well as providers' perceptions of the acceptability, appropriateness, and feasibility of both the evidence-based practices and implementation strategies. We will use data on care delivery to assess providers' implementation of evidence-based smoking cessation practices. RESULTS: The IMPACT study is being conducted at 5 clinic sites. More than 50 providers have been enrolled, exceeding our recruitment target. The study is ongoing. CONCLUSIONS: In order for persons with SMI to realize the benefits of smoking cessation treatment, it is important for clinicians to implement evidence-based practices successfully. This pilot study will result in a set of training modules, implementation tools, and resources for clinicians working in community mental health clinics to address tobacco smoking with their clients. Trial Registration: ClinicalTrials.gov NCT04796961; https://clinicaltrials.gov/ct2/show/NCT04796961. TRIAL REGISTRATION: ClinicalTrials.gov NCT04796961; https://clinicaltrials.gov/ct2/show/NCT04796961. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44787.

Designing Practical Motivational Interviewing Training for Mental Health Practitioners Implementing Behavioral Lifestyle Interventions: Protocol for 3 Pilot Intervention Studies.

BACKGROUND: Motivational interviewing (MI) is an evidence-based, patient-centered communication method shown to be effective in helping persons with serious mental illness (SMI) to improve health behaviors. In clinical trials where study staff conducted lifestyle interventions incorporating an MI approach, cardiovascular disease (CVD) risk profiles of participants with SMI showed improvement. Given the disproportionate burden of CVD in this population, practitioners who provide somatic and mental health care to persons with SMI are ideally positioned to deliver patient-centered CVD risk reduction interventions. However, the time for MI training (traditionally 16-24 hours), follow-up feedback, and the coaching required to develop and maintain patient-centered skills are significant barriers to incorporating MI when scaling up these evidence-based practices. OBJECTIVE: We describe the design and development of the following 2 scalable MI training approaches for community mental health practitioners: real-time brief workshops and follow-up asynchronous avatar training. These approaches are being used in 3 different pilot implementation research projects that address weight loss, smoking cessation, and CVD risk reduction in people with SMI who are a part of ALACRITY Center, a research-to-practice translation center funded by the National Institute of Mental Health. METHODS: Clinicians and staff in community mental health clinics across Maryland were trained to deliver 3 distinct evidence-based physical health lifestyle interventions using an MI approach to persons with SMI. The real-time brief MI workshop training for ACHIEVE-D weight loss coaches was 4 hours; IMPACT smoking cessation counselors received 2-hour workshops and prescribers received 1-hour workshops; and RHYTHM CVD risk reduction program staff received 4 hours of MI. All workshop trainings occurred over videoconference. The asynchronous avatar training includes 1 common didactic instructional module for the 3 projects and 1 conversation simulation unique to each study's target behavior. Avatar training is accessible on a commercial website. We plan to assess practitioners' attitudes and beliefs about MI and evaluate the impact of the 2 MI training approaches on their MI skills 3, 6, and 12 months after training using the MI Treatment Integrity 4.2.1 coding tool and the data generated by the avatar-automated scoring system. RESULTS: The ALACRITY Center was funded in August 2018. We have implemented the MI training for 126 practitioners who are currently delivering the 3 implementation projects. We expect the studies to be complete in May 2023. CONCLUSIONS: This study will contribute to knowledge about the effect of brief real-time training augmented with avatar skills practice on clinician MI skills. If MI Treatment Integrity scoring shows it to be effective, brief videoconference trainings supplemented with avatar skills practice could be used to train busy community mental health practitioners to use an MI approach when implementing physical health interventions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44830.

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.

Scaling Evidence-Based Interventions to Improve the Cardiovascular Health of People With Serious Mental Illness.

People with serious mental illnesses (SMIs) experience excess mortality, driven in large part by high rates of cardiovascular disease (CVD), with all cardiovascular disease risk factors elevated. Interventions designed to improve the cardiovascular health of people with SMI have been shown to lead to clinically significant improvements in clinical trials; however, the uptake of these interventions into real-life clinical settings remains limited. Implementation strategies, which constitute the "how to" component of changing healthcare practice, are critical to supporting the scale-up of evidence-based interventions that can improve the cardiovascular health of people with SMI. And yet, implementation strategies are often poorly described and rarely justified theoretically in the literature, limiting the ability of researchers and practitioners to tease apart why, what, how, and when implementation strategies lead to improvement. In this Perspective, we describe the implementation strategies that the Johns Hopkins ALACRITY Center for Health and Longevity in Mental Illness is using to scale-up three evidenced-based interventions related to: (1) weight loss; (2) tobacco smoking cessation treatment; and (3) hypertension, dyslipidemia, and diabetes care for people with SMI. Building on concepts from the literature on complex health interventions, we focus on considerations related to the core function of an intervention (i.e., or basic purposes of the change process that the health intervention seeks to facilitate) vs. the form (i.e., implementation strategies or specific activities taken to carry out core functions that are customized to local contexts). By clearly delineating how implementation strategies are operationalized to support the interventions' core functions across these three studies, we aim to build and improve the future evidence base of how to adapt, implement, and evaluate interventions to improve the cardiovascular health of people with SMI.

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.

Healthy for Two/Healthy for You: Design and methods for a pragmatic randomized clinical trial to limit gestational weight gain and prevent obesity in the prenatal care setting.

OBJECTIVE: To compare the effect of Healthy for Two/Healthy for You (H42/H4U), a health coaching program, in prenatal care clinics that serve a racially and economically diverse population, on total gestational weight gain (GWG) (vs. usual care). We hypothesize that compared to usual prenatal care, intervention participants will have lower GWG and lower rates of gestational diabetes mellitus (GDM). METHODS: We report the rationale and design of a pragmatic, parallel arm randomized clinical trial with 380 pregnant patients ≤15 weeks gestation with overweight or obesity from one of 6 academic and community-based obstetrics practices, randomized to either H42/H4U or usual prenatal care in a 1:1 ratio. The study duration is early pregnancy to 6 months postpartum. The primary outcome is total GWG, calculated as the difference between first clinic-assessed pregnancy weight and the weight at 37 weeks gestation. Key maternal and infant secondary outcomes include GDM incidence, weight retention at 6 months postpartum, infant weight, maternal health behaviors and wellness. CONCLUSIONS: This pragmatic clinical trial embeds a pregnancy health coaching program into prenatal care to allow parallel testing compared to usual prenatal care on the outcome of total GWG. The real-world design provides an approach to enhance its sustainability beyond the trial to ultimately improve maternal/child health outcomes and reduce future obesity. TRIAL REGISTRATION: The study was first registered at clinicaltrials.gov on 1/26/21 (NCT04724330).

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.

Adapting the Comprehensive Unit Safety Program (CUSP) implementation strategy to increase delivery of evidence-based cardiovascular risk factor care in community mental health organizations: protocol for a pilot study.

BACKGROUND: People with serious mental illnesses (SMI) such as schizophrenia and bipolar disorder experience excess mortality driven in large part by high rates of poorly controlled and under-treated cardiovascular risk factors. In the USA, integrated "behavioral health home" models in which specialty mental health organizations coordinate and manage physical health care for people with SMI are designed to improve guideline-concordant cardiovascular care for this group. Such models have been shown to improve cardiovascular care for clients with SMI in randomized clinical trials, but real-world implementation has fallen short. Key implementation barriers include lack of alignment of specialty mental health program culture and physical health care coordination and management for clients with SMI and lack of structured protocols for conducting effective physical health care coordination and management in the specialty mental health program context. This protocol describes a pilot study of an implementation intervention designed to overcome these barriers. METHODS: This pilot study uses a single-group, pre/post-study design to examine the effects of an adapted Comprehensive Unit Safety Program (CUSP) implementation strategy designed to support behavioral health home programs in conducting effective cardiovascular care coordination and management for clients with SMI. The CUSP strategy, which was originally designed to improve inpatient safety, includes provider training, expert facilitation, and implementation of a five-step quality improvement process. We will examine the acceptability, appropriateness, and feasibility of the implementation strategy and how this strategy influences mental health organization culture; specialty mental health providers' self-efficacy to conduct evidence-based cardiovascular care coordination and management; and receipt of guideline-concordant care for hypertension, dyslipidemia, and diabetes mellitus among people with SMI. DISCUSSION: While we apply CUSP to the implementation of evidence-based hypertension, dyslipidemia, and diabetes care, this implementation strategy could be used in the future to support the delivery of other types of evidence-based care, such as smoking cessation treatment, in behavioral health home programs. CUSP is designed to be fully integrated into organizations, sustained indefinitely, and used to continually improve evidence-based practice delivery. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04696653 . Registered on January 6, 2021.

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.

Applying Care Coordination Principles to Reduce Cardiovascular Disease Risk Factors in People With Serious Mental Illness: A Case Study Approach.

People with serious mental illness (SMI) have a 2-3-fold higher mortality than the general population, much of which is driven by largely preventable cardiovascular disease. One contributory factor is the disconnect between the behavioral and physical health care systems. New care models have sought to integrate physical health care into primary mental health care settings. However, few examples of successful care coordination interventions to improve health outcomes with the SMI population exist. In this paper, we examine challenges faced in coordinating care for people with SMI and explore pragmatic, multi-disciplinary strategies for overcoming these challenges used in a cardiovascular risk reduction intervention shown to be effective in a clinical trial.

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.

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.

The Effects of a Remote-based Weight Loss Program on Adipocytokines, Metabolic Markers, and Telomere Length in Breast Cancer Survivors: the POWER-Remote Trial.

PURPOSE: We initiated a clinical trial to determine the proportion of breast cancer survivors achieving ≥5% weight loss using a remotely delivered weight loss intervention (POWER-remote) or a self-directed approach, and to determine the effects of the intervention on biomarkers of cancer risk including metabolism, inflammation, and telomere length. EXPERIMENTAL DESIGN: Women with stage 0-III breast cancer, who completed local therapy and chemotherapy, with a body mass index ≥25 kg/m2 were randomized to a 12-month intervention (POWER-remote) versus a self-directed approach. The primary objective was to determine the number of women who achieved at least 5% weight loss at 6 months. We assessed baseline and 6-month change in a panel of adipocytokines (adiponectin, leptin, resistin, HGF, NGF, PAI1, TNFα, MCP1, IL1ß, IL6, and IL8), metabolic factors (insulin, glucose, lipids, hs-CRP), and telomere length in peripheral blood mononuclear cells. RESULTS: From 2013 to 2015, 96 women were enrolled, and 87 were evaluable for the primary analysis; 45 to POWER-remote and 42 to self-directed. At 6 months, 51% of women randomized to POWER-remote lost ≥5% of their baseline body weight, compared with 12% in the self-directed arm [OR, 7.9; 95% confidence interval (CI), 2.6-23.9; P = 0.0003]; proportion were similar at 12 months (51% vs 17%, respectively, P = 0.003). Weight loss correlated with significant decreases in leptin, and favorable modulation of inflammatory cytokines and lipid profiles. There was no significant change in telomere length at 6 months. CONCLUSIONS: A remotely delivered weight loss intervention resulted in significant weight loss in breast cancer survivors, and favorable effects on several biomarkers.