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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. [ABSTRACT FROM AUTHOR]

Abstract Background Racial disparities in blood pressure control have been well documented in the United States. Research suggests that many factors contribute to this disparity, including barriers to care at patient, clinician, healthcare system, and community levels. To date, few interventions aimed at reducing hypertension disparities have addressed factors at all of these levels. This paper describes the design of Project ReD CHiP (Reducing Disparities and Controlling Hypertension in Primary Care), a multi-level system quality improvement project. By intervening on multiple levels, this project aims to reduce disparities in blood pressure control and improve guideline concordant hypertension care. Methods Using a pragmatic trial design, we are implementing three complementary multi-level interventions designed to improve blood pressure measurement, provide patient care management services and offer expanded provider education resources in six primary care clinics in Baltimore, Maryland. We are staggering the introduction of the interventions and will use Statistical Process Control (SPC) charting to determine if there are changes in outcomes at each clinic after implementation of each intervention. The main hypothesis is that each intervention will have an additive effect on improvements in guideline concordant care and reductions in hypertension disparities, but the combination of all three interventions will result in the greatest impact, followed by blood pressure measurement with care management support, blood pressure measurement with provider education, and blood pressure measurement only. This study also examines how organizational functioning and cultural competence affect the success of the interventions. Discussion As a quality improvement project, Project ReD CHiP employs a novel study design that specifically targets multi-level factors known to contribute to hypertension disparities. To facilitate its implementation and improve its sustainability, we have incorporated stakeholder input and tailored components of the interventions to meet the specific needs of the involved clinics and communities. Results from this study will provide knowledge about how integrated multi-level interventions can improve hypertension care and reduce disparities. Trial Registration ClinicalTrials.gov NCT01566864

BackgroundThe 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. ObjectiveThis 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. MethodsAdults 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. ResultsParticipants 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). ConclusionParticipants 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 RegistrationNCT00054925; http://clinicaltrials.gov/ct2/show/NCT00054925 (Archived by WebCite at http://www.webcitation.org/5rC7523ue)

Objective - The purpose of this study was to evaluate participants' perceptions of the weight-loss intervention used in a hypertension prevention clinical trial. Design - A total of 308 overweight and moderately obese subjects participated in the weight-management intervention. After the 18-month program, 281 participants completed a questionnaire designed to evaluate their perceptions of the program's effectiveness. Subjects/setting - Adult participants (224 men and 84 women) in the weight-loss modality of the Trials of Hypertension Prevention Phase I, surveyed in 1991. Statistical analyses performed - [Χ.sup.2] Analyses were used to test for statistical significance of group differences. Results - Intervention components that were most useful are presented. Older participants (older than 50 years) were most likely to attend sessions and women were most likely to identify stress and frustration because of disappointing results. Successful participants were more likely to incorporate exercise into their dally activities, exercise regularly, and use self-monitoring strategies. Few participants found group exercise to be useful. Conclusion - These findings suggest that interventionists in weight-loss programs need to find flexible and creative ways to maintain contact with participants, continue to develop better methods of self-monitoring, obtain the skills needed to recognize frustration and provide timely support, continue to couple the message of diet and exercise, and emphasize helping participants develop their problem-solving skills. This may require training outside the traditional field of dietetics., Obesity has been referred to as 'one of the most common and important medical conditions affecting Americans' (1, p 967). Approximately one third of US adults are substantially overweight (2) [...]

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. [ABSTRACT FROM AUTHOR]

Abstract 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. Trial Registration Clinical Trials.gov NCT00902694

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: In the Weight Loss Maintenance (WLM) Trial, a personal contact (PC) intervention sustained greater weight loss relative to a self-directed (SD) group over 30 months. This study investigated the effects of continued intervention over an additional 30 months and overall weight change across the entire WLM Trial.Methods: WLM had 3 phases. Phase 1 was a 6-month weight loss program. In Phase 2, those who lost ≥4 kg were randomized to a 30-month maintenance trial. In Phase 3, PC participants (n = 196, three sites) were re-randomized to no further intervention (PC-Control) or continued intervention (PC-Active) for 30 more months; 218 SD participants were also followed.Results: During Phase 3, weight increased 1.0 kg in PC-Active and 0.5 kg in PC-Control (mean difference 0.6 kg; 95% CI:-1.4 to 2.7; P = 0.54). Mean weight change over the entire study was -3.2 kg in those originally assigned to PC (PC-Combined) and -1.6 kg in SD (mean difference -1.6 kg; 95% CI:-3.0 to -0.1; P = 0.04).Conclusions: After 30 months of the PC maintenance intervention, continuation for another 30 months provided no additional benefit. However, across the entire study, weight loss was slightly greater in those originally assigned to PC. [ABSTRACT FROM AUTHOR]

Introduction: Unhealthy diets, often low in potassium, likely contribute to racial disparities in blood pressure. We tested the effectiveness of providing weekly dietary advice, assistance with selection of higher potassium grocery items, and a $30 per week food allowance on blood pressure and other outcomes in African American adults with hypertension.Design: We conducted an 8-week RCT with two parallel arms between May 2012 and November 2013.Setting/participants: We randomized 123 African Americans with controlled hypertension from an urban primary care clinic in Baltimore, Maryland, and implemented the trial in partnership with a community supermarket and the Baltimore City Health Department. Mean (SD) age was 58.6 (9.5) years; 71% were female; blood pressure was 131.3 (14.7)/77.2 (10.5) mmHg; BMI was 34.5 (8.2); and 28% had diabetes.Intervention: Participants randomized to the active intervention group (Dietary Approaches to Stop Hypertension [DASH]-Plus) received coach-directed dietary advice and assistance with weekly online ordering and purchasing of high-potassium foods ($30/week) delivered by a community supermarket to a neighborhood library. Participants in the control group received a printed DASH diet brochure along with a debit account of equivalent value to that of the DASH-Plus group.Main Outcome Measures: The primary outcome was blood pressure change. Analyses were conducted in January to October 2014.Results: Compared with the control group, the DASH-Plus group increased self-reported consumption of fruits and vegetables (mean=1.4, 95% CI=0.7, 2.1 servings/day); estimated intake of potassium (mean=0.4, 95% CI=0.1, 0.7 grams/day); and urine potassium excretion (mean=19%, 95% CI=1%, 38%). There was no significant effect on blood pressure.Conclusions: A program providing dietary advice, assistance with grocery ordering, and $30/week of high-potassium foods in African American patients with controlled hypertension in a community-based clinic did not reduce BP. However, the intervention increased consumption of fruits, vegetables, and urinary excretion of potassium. [ABSTRACT FROM AUTHOR]

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., Competing Interests: Conflict of Interest: No conflicts of interest to report.

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., (©Gerald J Jerome, Stacy Goldsholl, Arlene T Dalcin, Joseph V Gennusa 3rd, Christina T Yuan, Kristal Brown, Tyler Fink, Eva Minahan, Nae-Yuh Wang, Gail L Daumit, Kimberly Gudzune. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 10.05.2023.)