Increasing Equity of Physical Activity Promotion for Optimal Cardiovascular Health in Adults: A Scientific Statement From the American Heart Association.

Fewer than 1 in 4 adults achieves the recommended amount of physical activity, with lower activity levels reported among some groups. Addressing low levels of physical activity among underresourced groups provides a modifiable target with the potential to improve equity in cardiovascular health. This article (1) examines physical activity levels across strata of cardiovascular disease risk factors, individual level characteristics, and environmental factors; (2) reviews strategies for increasing physical activity in groups who are underresourced or at risk for poor cardiovascular health; and (3) provides practical suggestions for physical activity promotion to increase equity of risk reduction and to improve cardiovascular health. Physical activity levels are lower among those with elevated cardiovascular disease risk factors, among certain groups (eg, older age, female, Black race, lower socioeconomic status), and in some environments (eg, rural). There are strategies for physical activity promotion that can specifically support underresourced groups such as engaging the target community in designing and implementing interventions, developing culturally appropriate study materials, identifying culturally tailored physical activity options and leaders, building social support, and developing materials for those with low literacy. Although addressing low physical activity levels will not address the underlying structural inequities that deserve attention, promoting physical activity among adults, especially those with both low physical activity levels and poor cardiovascular health, is a promising and underused strategy to reduce cardiovascular health inequalities.

Supporting Physical Activity in Patients and Populations During Life Events and Transitions: A Scientific Statement From the American Heart Association.

Achieving recommended levels of physical activity is important for optimal cardiovascular health and can help reduce cardiovascular disease risk. Emerging evidence suggests that physical activity fluctuates throughout the life course. Some life events and transitions are associated with reductions in physical activity and, potentially, increases in sedentary behavior. The aim of this scientific statement is to first provide an overview of the evidence suggesting changes in physical activity and sedentary behavior across life events and transitions. A second aim is to provide guidance for health care professionals or public health workers to identify changes and promote physical activity during life events and transitions. We offer a novel synthesis of existing data, including evidence suggesting that some subgroups are more likely to change physical activity behaviors in response to life events and transitions. We also review the evidence that sedentary behavior changes across life events and transitions. Tools for health care professionals to assess physical activity using simple questions or wearable devices are described. We provide strategies for health care professionals to express compassion as they ask about life transitions and initiate conversations about physical activity. Last, resources for life phase-specific, tailored physical activity support are included. Future research needs include a better characterization of physical activity and sedentary behavior across life events and transitions in higher-risk subgroups. Development and testing of interventions designed specifically to combat declines in physical activity or increases in sedentary behavior during life events and transitions is needed to establish or maintain healthy levels of these cardiovascular health-promoting behaviors.

Longitudinal and Cross-Sectional Association Between Gait Speed, Ankle Proprioception, and LE Numbness-Results From the Baltimore Longitudinal Study of Aging.

Mobility declines in older adults can be determined through monitoring longitudinal changes in gait speed. We examined longitudinal changes [in] ankle proprioception among those with and without baseline lower extremity numbness to develop a better understanding of mobility declines in healthy older adults. Participants included 568 adults (52.8% women) aged 60-98 years from the Baltimore Longitudinal Study of Aging. Larger ankle proprioception decreases during plantar flexion were found in the participants with lower extremity numbness compared with those without numbness (p = .034). Among participants with lower extremity numbness, slower baseline speeds from both usual and fast pace gait were associated with performance decline in ankle proprioception measured during ankle dorsiflexion (p = .039 and p = .004, respectively). Assisting older adults, especially those with lower extremity numbness, to maintain and improve ankle proprioception may help prevent mobility declines that have previously been considered age related.

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.

Obstacle-Crossing Task-Related Usual Gait Patterns of Older Adults Differentiating Falls and Gait Ability.

Obstacle crossing, such as stepping over a curb, exerts additional demands on balance control, and therefore the study of usual-pace gait patterns associated with obstacle-crossing performance may provide additional insight into understanding falls and deterioration of gait in older adults. Participants included 432 adults aged 60-96 years (218 women). Participants who failed the obstacle-crossing task (n = 181) walked slower with smaller knee range of motion than participants who successfully completed the obstacle-crossing task (all ps < .001). Participants who failed the obstacle crossing reported a greater likelihood of falling in the previous year, more balance problems, lower walking ability, and needed longer time to complete 5 chair stands than those who passed the task (all ps < .05). Obstacle-crossing task may identify gait patterns in older adults who appear functionally intact, but who are nonetheless at risk of fall and balance problems.

Obese Breast Cancer Patients and Survivors: Management Considerations.

Excess body weight is a significant risk factor for many cancers, especially breast cancer. Patients with breast cancer or those with a history of the disease who are overweight or obese have an increased risk of therapy-related morbidity, recurrence, and breast cancer-related mortality. Obesity may also affect quality-of-life factors for survivors, including sexual dysfunction, neuropathy, cardiotoxicity, chronic fatigue, and lymphedema. Most cancer guidelines recommend that breast cancer survivors who are overweight or obese lose weight and that those with a normal body mass index (BMI) maintain a stable body weight. The cornerstone of interventions to treat or prevent obesity is lifestyle modification with diet and exercise; however, integrating these things into clinical practice is challenging. This article will present feasible weight loss interventions, and will discuss practical implications of ongoing chemotherapy and endocrine therapy with regard to weight gain, and the impact of obesity on therapy-related conditions during breast cancer survivorship.

Use of online recruitment strategies in a randomized trial of cancer survivors.

BACKGROUND/AIMS: Despite widespread Internet adoption, online advertising remains an underutilized tool to recruit participants into clinical trials. Whether online advertising is a cost-effective method to enroll participants compared to other traditional forms of recruitment is not known. METHODS: Recruitment for the Survivorship Promotion In Reducing IGF-1 Trial, a community-based study of cancer survivors, was conducted from June 2015 through December 2016 via in-person community fairs, advertisements in periodicals, and direct postal mailings. In addition, "Right Column" banner ads were purchased from Facebook to direct participants to the Survivorship Promotion In Reducing IGF-1 Trial website. Response rates, costs of traditional and online advertisements, and demographic data were determined and compared across different online and traditional recruitment strategies. Micro-trials optimizing features of online advertisements were also explored. RESULTS: Of the 406 respondents to our overall outreach efforts, 6% (24 of 406) were referred from online advertising. Facebook advertisements were shown over 3 million times (impressions) to 124,476 people, which resulted in 4401 clicks on our advertisement. Of these, 24 people ultimately contacted study staff, 6 underwent prescreening, and 4 enrolled in the study. The cost of online advertising per enrollee was $794 when targeting a general population versus $1426 when accounting for strategies that specifically targeted African Americans or men. By contrast, community fairs, direct mail, or periodicals cost $917, $799, or $436 per enrollee, respectively. Utilization of micro-trials to assess online ads identified subtleties (e.g. use of an advertisement title) that substantially impacted viewer interest in our trial. CONCLUSION: Online advertisements effectively directed a relevant population to our website, which resulted in new enrollees in the Survivorship Promotion In Reducing IGF-1 Trial at a cost comparable to traditional methods. Costs were substantially greater with online recruitment when targeting under-represented populations, however. Additional research using online micro-trial tools is needed to evaluate means of more precise recruitment to improve yields in under-represented groups. Potential gains from faster recruitment speed remain to be determined.

Differential Gait Patterns by History of Falls and Knee Pain Status in Healthy Older Adults: Results From the Baltimore Longitudinal Study of Aging.

Consideration of knee pain can be crucial for identifying fall-related gait patterns. While walking, gait parameters at usual speed were examined in persons with different falls and knee pain status. A total of 439 adults aged 60-92 years participated in this study. Persons with a history of falls had a wider stride width (p = .036) and longer double support time (p = .034) than nonfallers. In the absence of knee pain, fallers had longer double support time than nonfallers (p = .012), but no differences in double support time by history of falls were observed in participants with knee pain. With slower gait speed, fallers with knee pain have narrower stride width and larger hip range of motion (p = .027 and p = .001, respectively). Results suggest the importance of considering knee pain in fall studies for better understanding the fall-related differential gait mechanisms and for designing fall prevention intervention strategies.

A behavioral weight-loss intervention in persons with serious mental illness.

BACKGROUND: Overweight and obesity are epidemic among persons with serious mental illness, yet weight-loss trials systematically exclude this vulnerable population. Lifestyle interventions require adaptation in this group because psychiatric symptoms and cognitive impairment are highly prevalent. Our objective was to determine the effectiveness of an 18-month tailored behavioral weight-loss intervention in adults with serious mental illness. METHODS: We recruited overweight or obese adults from 10 community psychiatric rehabilitation outpatient programs and randomly assigned them to an intervention or a control group. Participants in the intervention group received tailored group and individual weight-management sessions and group exercise sessions. Weight change was assessed at 6, 12, and 18 months. RESULTS: Of 291 participants who underwent randomization, 58.1% had schizophrenia or a schizoaffective disorder, 22.0% had bipolar disorder, and 12.0% had major depression. At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 36.3, and the mean weight was 102.7 kg (225.9 lb). Data on weight at 18 months were obtained from 279 participants. Weight loss in the intervention group increased progressively over the 18-month study period and differed significantly from the control group at each follow-up visit. At 18 months, the mean between-group difference in weight (change in intervention group minus change in control group) was -3.2 kg (-7.0 lb, P=0.002); 37.8% of the participants in the intervention group lost 5% or more of their initial weight, as compared with 22.7% of those in the control group (P=0.009). There were no significant between-group differences in adverse events. CONCLUSIONS: A behavioral weight-loss intervention significantly reduced weight over a period of 18 months in overweight and obese adults with serious mental illness. Given the epidemic of obesity and weight-related disease among persons with serious mental illness, our findings support implementation of targeted behavioral weight-loss interventions in this high-risk population. (Funded by the National Institute of Mental Health; ACHIEVE ClinicalTrials.gov number, NCT00902694.).

Effectiveness of an Activity Tracker- and Internet-Based Adaptive Walking Program for Adults: A Randomized Controlled Trial.

BACKGROUND: The benefits of physical activity are well documented, but scalable programs to promote activity are needed. Interventions that assign tailored and dynamically adjusting goals could effect significant increases in physical activity but have not yet been implemented at scale. OBJECTIVE: Our aim was to examine the effectiveness of an open access, Internet-based walking program that assigns daily step goals tailored to each participant. METHODS: A two-arm, pragmatic randomized controlled trial compared the intervention to no treatment. Participants were recruited from a workplace setting and randomized to a no-treatment control (n=133) or to treatment (n=132). Treatment participants received a free wireless activity tracker and enrolled in the walking program, Walkadoo. Assessments were fully automated: activity tracker recorded primary outcomes (steps) without intervention by the participant or investigators. The two arms were compared on change in steps per day from baseline to follow-up (after 6 weeks of treatment) using a two-tailed independent samples t test. RESULTS: Participants (N=265) were 66.0% (175/265) female with an average age of 39.9 years. Over half of the participants (142/265, 53.6%) were sedentary (<5000 steps/day) and 44.9% (119/265) were low to somewhat active (5000-9999 steps/day). The intervention group significantly increased their steps by 970 steps/day over control (P<.001), with treatment effects observed in sedentary (P=.04) and low-to-somewhat active (P=.004) participants alike. CONCLUSIONS: The program is effective in increasing daily steps. Participants benefited from the program regardless of their initial activity level. A tailored, adaptive approach using wireless activity trackers is realistically implementable and scalable. TRIAL REGISTRATION: Clinicaltrials.gov NCT02229409, https://clinicaltrials.gov/ct2/show/NCT02229409 (Archived by WebCite at http://www.webcitation.org/6eiWCvBYe).

Application of Latent Class Analysis to Identify Behavioral Patterns of Response to Behavioral Lifestyle Interventions in Overweight and Obese Adults.

BACKGROUND: Examining responders and non-responders to behavioral lifestyle interventions among overweight/obese adults with additional comorbidities may aid in refining and tailoring obesity treatment. PURPOSE: The purpose of this study is to demonstrate the use of latent class analysis to identify patterns of response to behavioral lifestyle interventions based on adherence to diet and exercise recommendations. METHOD: Repeated measures latent class analysis was applied to two clinical trial datasets, combination of two active interventions in the PREMIER Trial (n = 501) and phase 1 of the Weight Loss Maintenance Trial (WLM; n = 1685), to identify patterns of response to behavioral lifestyle interventions. Treatment response was based on adherence to daily recommendations for fruit/vegetable, fat, saturated fat, sodium, and exercise at baseline and 6 months. RESULTS: In PREMIER, three distinct latent classes emerged: responders (45.9%), non-responders (23.6%), and early adherers (30.5%). Responders and Early Adherers had greater weight loss at 6 and 18 months and were more likely to meet behavioral recommendations at 18 months than Non-responders. For WLM, there were four latent classes: partial responders (16%), non-responders (40%), early adherers (2%), and fruit/veggie only responders (41%). Non-responders in WLM had significantly less weight loss at 6 months compared to that of the other three latent classes. CONCLUSION: Latent class analysis is a useful method to apply to clinical trial data to identify distinct patterns of response to behavioral interventions. Overweight/ obese participants who respond to behavioral lifestyle treatment (i.e., meet behavioral recommendations) have significantly greater weight loss than that of participants who do not make behavioral changes.

Comparative effectiveness of weight-loss interventions in clinical practice.

BACKGROUND: Obesity and its cardiovascular complications are extremely common medical problems, but evidence on how to accomplish weight loss in clinical practice is sparse. METHODS: We conducted a randomized, controlled trial to examine the effects of two behavioral weight-loss interventions in 415 obese patients with at least one cardiovascular risk factor. Participants were recruited from six primary care practices; 63.6% were women, 41.0% were black, and the mean age was 54.0 years. One intervention provided patients with weight-loss support remotely--through the telephone, a study-specific Web site, and e-mail. The other intervention provided in-person support during group and individual sessions, along with the three remote means of support. There was also a control group in which weight loss was self-directed. Outcomes were compared between each intervention group and the control group and between the two intervention groups. For both interventions, primary care providers reinforced participation at routinely scheduled visits. The trial duration was 24 months. RESULTS: At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) for all participants was 36.6, and the mean weight was 103.8 kg. At 24 months, the mean change in weight from baseline was -0.8 kg in the control group, -4.6 kg in the group receiving remote support only (P<0.001 for the comparison with the control group), and -5.1 kg in the group receiving in-person support (P<0.001 for the comparison with the control group). The percentage of participants who lost 5% or more of their initial weight was 18.8% in the control group, 38.2% in the group receiving remote support only, and 41.4% in the group receiving in-person support. The change in weight from baseline did not differ significantly between the two intervention groups. CONCLUSIONS: In two behavioral interventions, one delivered with in-person support and the other delivered remotely, without face-to-face contact between participants and weight-loss coaches, obese patients achieved and sustained clinically significant weight loss over a period of 24 months. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT00783315.).

Psychosocial predictors of weight regain in the weight loss maintenance trial.

This study's purpose was to identify psychosocial predictors of weight loss maintenance in a multi-site clinical trial, following a group-based weight loss program. Participants (N = 1025) were predominately women (63%) and 38% were Black (mean age = 55.6 years; SD = 8.7). At 12 months, higher SF-36 mental health composite scores were associated with less weight regain (p < .01). For Black participants, an interaction existed between race and friends' encouragement for exercise, where higher exercise encouragement was related to more weight regain (p < .05). At 30 months, friends' encouragement for healthy eating was associated with more weight regain (p < .05), whereas higher SF-36 mental health composite scores were related to less weight regain (p < .0001). Perceived stress and select health-related quality of life indices were associated with weight regain; this relationship varied across gender, race, and treatment conditions. Temporal changes in these variables should be investigated for their impact on weight maintenance.

Longitudinal accuracy of web-based self-reported weights: results from the Hopkins POWER Trial.

BACKGROUND: Websites and phone apps are increasingly used to track weights during weight loss interventions, yet the longitudinal accuracy of these self-reported weights is uncertain. OBJECTIVE: Our goal was to compare the longitudinal accuracy of self-reported weights entered online during the course of a randomized weight loss trial to measurements taken in the clinic. We aimed to determine if accuracy of self-reported weight is associated with weight loss and to determine the extent of misclassification in achieving 5% weight loss when using self-reported compared to clinic weights. METHODS: This study examined the accuracy of self-reported weights recorded online among intervention participants in the Hopkins Practice-Based Opportunities for Weight Reduction (POWER) trial, a randomized trial examining the effectiveness of two lifestyle-based weight loss interventions compared to a control group among obese adult patients with at least one cardiovascular risk factor. One treatment group was offered telephonic coaching and the other group was offered in-person individual coaching and group sessions. All intervention participants (n=277) received a digital scale and were asked to track their weight weekly on a study website. Research staff used a standard protocol to measure weight in the clinic. Differences (self-reported weight - clinic weight) indicate if self-report under (-) or over (+) estimated clinic weight using the self-reported weight that was closest in time to the clinic weight and was within a window ranging from the day of the clinic visit to 7 days before the 6-month (n=225) and 24-month (n=191) clinic visits. The absolute value of the differences (absolute difference) describes the overall accuracy. RESULTS: Underestimation of self-reported weights increased significantly from 6 months (mean -0.5 kg, SD 1.0 kg) to 24 months (mean -1.1 kg, SD 2.0 kg; P=.002). The average absolute difference also increased from 6 months (mean 0.7 kg, SD 0.8 kg) to 24 months (mean 1.3, SD 1.8 kg; P<.001). Participants who achieved the study weight loss goal at 24 months (based on clinic weights) had lower absolute differences (P=.01) compared to those who did not meet this goal. At 24 months, there was 9% misclassification of weight loss goal success when using self-reported weight compared to clinic weight as an outcome. At 24 months, those with self-reported weights (n=191) had three times the weight loss compared to those (n=73) without self-reported weights (P<.001). CONCLUSIONS: Underestimation of weight increased over time and was associated with less weight loss. In addition to intervention adherence, weight loss programs should emphasize accuracy in self-reporting. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00783315; http://clinicaltrials.gov/show/NCT00783315 (Archived by WebCite at http://www.webcitation.org/6R4gDAK5K).

Supporting Weight Loss Among Parents of Children With a Disability: Lessons Learned From a Single-Arm Pilot Study.

This study assessed weight change in the parents of children with disabilities following a 12-week, remotely delivered weight loss program focused on lifestyle modifications and found a significant median weight reduction of 3 kg from baseline to week 12.

Investigating balance-related gait patterns and their relationship with maximum torques generated by the hamstrings and quadriceps in older adults - Results from the Baltimore longitudinal study of aging.

BACKGROUND: Balance-related gait patterns in older adults can be objectively discerned through the examination of gait parameters, maximum leg torques, and their interconnections. OBJECTIVE: To investigate the correlation between leg muscle strength and balance during gait concerning functional performance in healthy older adults. METHODS: Participants included 117 adults aged 60-95 years were recruited from the Baltimore Longitudinal Study of Aging (BLSA). They underwent evaluations of gait, balance, and maximum isometric leg torque (for both hamstrings and quadriceps). Analyses examined the association between leg torque and functional performance among those with higher and lower balances. RESULTS: Individuals with lower balance (n = 43) were older, more prone to experiencing a fear of falling, and exhibited lower functional performance (gait speeds and Generalized Gait Stability Scores (GGSS), ps < 0.001) compared to their counterparts with higher balance (n = 74). At a usual walking pace, the GGSS showed a positive association with concentric Quadriceps Maximum Torque (QMT) in participants with lower balance (p = 0.013). Conversely, it displayed a positive association with eccentric QMT in those with higher balance (p = 0.014). At a fast walking pace, only individuals with higher balance demonstrated a positive muscle torque association with both gait speed and GGSS, encompassing concentric and eccentric actions in both the quadriceps and hamstrings (ps < 0.050). CONCLUSION: Evaluating muscle strength capacity in both concentric and eccentric phases during dynamic high-effort events, along with investigating their associations with gait performance, can be beneficial for identifying subtle gait deficits. This comprehensive approach may assist in the early detection of gait deterioration among healthy older adults, given the intricate muscle activations involved in lower body functional performance.

Psychological and Structural Burdens and Nursing Home Administrator Turnover Intentions During the COVID-19 Pandemic.

The COVID-19 pandemic created challenges for U. S. nursing home administrators (NHA) and staff. This study explored organizational and psychological factors associated with NHA stress, dissatisfaction, and turnover intent (TI) during the third year of the pandemic. Results from a nationwide, cross-sectional survey of 1139 NHAs were merged with Centers for Medicare and Medicaid Services nursing home survey deficiency, staffing, complaint, and other operations data. A hierarchical, generalized estimating equations model with ordered logit link found that NHAs with higher COVID stress (AOR = 1.65, 95% CI = 1.22, 2.23), higher use of agency/contract staff (AOR = 1.50, 95% CI = 1.08.2.09) and higher role conflict were more likely to indicate TI. NHAs with higher job satisfaction in workload, work content, and rewards were less likely to hold TI. Industry leaders should create strategies to reduce NHA's job stress and role conflicts and provide opportunities for improving staff recruitment and retention, reducing reliance on agency staffing.

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.

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

[This corrects the article DOI: 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.