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This randomized clinical trial investigates if an 18-month tobacco-smoking cessation intervention including weight management is effective in adults with serious mental illness who may not be ready to quit smoking right away. Key Points: Question: Is an 18-month, tobacco-smoking cessation intervention with pharmacologic and behavioral components, including weight management, effective in adults with serious mental illness who are not necessarily ready to quit smoking right away? Findings: In this randomized clinical trial enrolling 192 participants in community settings who reported interest in quitting smoking within 1 or 6 months, 26.4% of the intervention group and 5.7% of the control group achieved smoking abstinence at 18 months, without significant weight gain. Meaning: These findings support implementation of extended-duration tobacco cessation treatment to reduce smoking rates and cardiovascular risk in this population with elevated smoking and obesity prevalence. 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 [ABSTRACT FROM AUTHOR]

Current guidelines published by the American Heart Association and the American College of Cardiology broadly recommend lifestyle approaches to prevent and treat elevated blood pressure and cholesterol. For patients with mildly or moderately elevated blood pressure and blood cholesterol, lifestyle-only approaches are the first line of therapy. The purpose of this scientific statement is to: (1) highlight the mild-moderate-risk patient groups indicated for lifestyle-only treatment for elevated blood pressure or cholesterol; (2) describe recommendations, average effects, and additional considerations when prescribing lifestyle treatment with physical activity; and (3) provide guidance and resources for clinicians to assess, prescribe, counsel, and refer to support increased physical activity in their patients. An estimated 21% and 28% to 37% of US adults, respectively, have mild-moderate-risk blood pressure and cholesterol and should receive lifestyle-only as first-line treatment. Of the recommended lifestyle changes, increasing physical activity has extensive benefits, including improving both blood pressure and blood cholesterol, that are comparable, superior, or complementary to other healthy lifestyle changes. Physical activity assessment and prescription are an excellent lifestyle behavior treatment option for all patients, including for the large population of mild-moderate-risk patients with elevated blood pressure and blood cholesterol. [ABSTRACT FROM AUTHOR]

Persons with serious mental illnesses (SMI) such as schizophrenia and bipolar disorder have an increased risk of obesity and related chronic diseases and die 10–20 years earlier than the overall population, primarily due to cardiovascular disease. In the ACHIEVE trial, a behavioural weight loss intervention led to clinically significant weight loss in persons with SMI. As the field turns its attention to intervention scale-up, it is important to understand whether the effectiveness of behavioural weight loss interventions for people with SMI, like ACHIEVE, differ for specific subgroups. This study examined whether the effectiveness of the ACHIEVE intervention differed by participant characteristics (e.g. age, sex, race, psychiatric diagnosis, body mass index) and/or their weight-related attitudes and behaviours (e.g. eating, food preparation, and shopping habits). We used likelihood-based mixed effects models to examine whether the baseline to 18 month effects of the ACHIEVE intervention differed across subgroups. No statistically significant differences were found in the effectiveness of the ACHIEVE intervention across any of the subgroups examined. These findings suggest that the ACHIEVE behavioural weight loss intervention is broadly applicable to the diverse population of individuals with SMI. [ABSTRACT FROM AUTHOR]

Abstract: Background: The benefits of regular physical activity are particularly salient to persons with serious mental illness (SMI) who have increased prevalence of obesity, diabetes, and earlier mortality from cardiovascular disease. Methods: The Activating Consumers to Exercise through Peer Support (ACE) trial will examine the effectiveness of peer support on adherence to a 4-month pilot exercise program for adults with SMI. Design, rationale and baseline data are reported. Baseline measures included: graded treadmill test; six-minute walk; height, weight and blood pressure; body composition; fasting blood; and self-reported psychiatric symptoms. Fitness levels were compared with national data and relationships among fitness parameters, psychological factors and cardiovascular disease risk factors were examined. Results: There were 93 participants and 18 peer leaders recruited from community psychiatry programs with an average age of 47 years (SD 10). There were no differences in demographics (76% female, 72% African American) or mental health symptoms between participants and peer leaders. Ninety-five percent of the sample had below average fitness levels for their age and sex with average MET levels of 5.9 (SD 2.2) for participants and 6.2 (SD 2.3) for peer leaders. Fitness evaluated during the treadmill test and the six-minute-walk were associated (r s  = 0.36, p < 0.001). Lower MET levels were associated with a higher BMI (r s  = −0.35, p < 0.001) and percent body fat (r s  = −0.36, p < 0.001). Conclusion: The uniformly low baseline cardiovascular fitness and the association of fitness with BMI and adiposity underscore the importance of suitably tailored programs to increase physical activity among adults with SMI. [Copyright &y& Elsevier]

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). [ABSTRACT FROM AUTHOR]

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). [ABSTRACT FROM AUTHOR]

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