Abstract Background: Cardiovascular disease is the leading cause of the estimated 11–25 years reduced life expectancy for persons with serious mental illness (SMI). This excess cardiovascular mortality is primarily attributable to obesity, diabetes, hypertension, and dyslipidaemia. Obesity is associated with a sedentary lifestyle, limited physical activity and an unhealthy diet. Lifestyle interventions for persons with SMI seem promising in reducing weight and cardiovascular risk. The aim of this study is to evaluate the effectiveness and cost-effectiveness of a lifestyle intervention among persons with SMI in an outpatient treatment setting. Methods: The Serious Mental Illness Lifestyle Evaluation (SMILE) study is a cluster-randomized controlled trial including an economic evaluation in approximately 18 Flexible Assertive Community Treatment (FACT) teams in the Netherlands. The intervention aims at a healthy diet and increased physical activity. Randomisation takes place at the level of participating FACT-teams. We aim to include 260 outpatients with SMI and a body mass index of 27 or higher who will either receive the lifestyle intervention or usual care. The intervention will last 12 months and consists of weekly 2-h group meetings delivered over the first 6 months. The next 6 months will include monthly group meetings, supplemented with regular individual contacts. Primary outcome is weight loss. Secondary outcomes are metabolic parameters (waist circumference, lipids, blood pressure, glucose), quality of life and health related self-efficacy. Costs will be measured from a societal perspective and include costs of the lifestyle program, health care utilization, medication and lost productivity. Measurements will be performed at baseline and 3, 6 and 12 months. Discussion: The SMILE intervention for persons with SMI will provide important information on the effectiveness, cost-effectiveness, feasibility and delivery of a group-based lifestyle intervention in a Dutch outpatient treatment setting. Trial registration: Dutch Trial Registration NL6660, registration date: 16 November 2017.
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Abstract Background: Lifestyle interventions for severe mental illness (SMI) are known to have small to modest efect on physical health outcomes. Little attention has been given to patient-reported outcomes (PROs). Aim: To systematically review the use of PROs and their measures, and quantify the efects of lifestyle interventions in patients with SMI on these PROs. Methods: Five electronic databases were searched (PubMed/Medline, Embase, PsycINFO, CINAHL, and Web of Science) from inception until 12 November 2020 (PROSPERO: CRD42020212135). Randomised controlled trials (RCTs) evaluating the efcacy of lifestyle interventions focusing on healthy diet, physical activity, or both for patients with SMI were included. Outcomes of interest were PROs. Results: A total of 11.267 unique records were identifed from the database search, 66 full-text articles were assessed, and 36 RCTs were included, of which 21 were suitable for meta-analyses. In total, 5.907 participants were included across studies. Lifestyle interventions had no signifcant efect on quality of life (g=0.13; 95% CI=−0.02 to 0.27), with high heterogeneity (I2 =68.7%). We found a small efect on depression severity (g=0.30, 95% CI=0.00 to 0.58, I2 =65.2%) and a moderate efect on anxiety severity (g=0.56, 95% CI=0.16 to 0.95, I2 =0%). Discussion: This meta-analysis quantifes the efects of lifestyle interventions on PROs. Lifestyle interventions have no signifcant efect on quality of life, yet they could improve mental health outcomes such as depression and anxiety symptoms. Further use of patient-reported outcome measures in lifestyle research is recommended to fully capture the impact of lifestyle interventions.
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Abstract Background: Antipsychotic-induced Weight Gain (AiWG) is a debilitating and common adverse effect of antipsychotics. AiWG negatively impacts life expectancy, quality of life, treatment adherence, likelihood of developing type-2 diabetes and readmission. Treatment of AiWG is currently challenging, and there is no consensus on the optimal management strategy. In this study, we aim to evaluate the use of metformin for the treatment of AiWG by comparing metformin with placebo in those receiving treatment as usual, which includes a lifestyle intervention. Methods: In this randomized, double-blind, multicenter, placebo-controlled, pragmatic trial with a follow-up of 52 weeks, we aim to include 256 overweight participants (Body Mass Index (BMI) > 25 kg/m2) of at least 16years of age. Patients are eligible if they have been diagnosed with schizophrenia spectrum disorder and if they have been using an antipsychotic for at least three months. Participants will be randomized with a 1:1 allocation to placebo or metformin, and will be treated for a total of 26 weeks. Metformin will be started at 500 mg b.i.d. and escalated to 1000 mg b.i.d. 2 weeks thereafter (up to a maximum of 2000mg daily). In addition, all participants will undergo a lifestyle intervention as part of the usual treatment consisting of a combination of an exercise program and dietary consultations. The primary outcome measure is difference in body weight as a continuous trait between the two arms from treatment inception until 26 weeks of treatment, compared to baseline. Secondary outcome measures include: 1) Any element of metabolic syndrome (MetS); 2) Response, defined as ≥5% body weight loss at 26 weeks relative to treatment inception; 3) Quality of life; 4) General mental and physical health; and 5) Cost-effectiveness. Finally, we aim to assess whether genetic liability to BMI and MetS may help estimate the amount of weight reduction following initiation of metformin treatment. Discussion: The pragmatic design of the current trial allows for a comparison of the efficacy and safety of metformin in combination with a lifestyle intervention in the treatment of AiWG, facilitating the development of guidelines on the interventions for this major health problem.
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Abstract Background: Several interventions have been developed to improve physical health and lifestyle behaviour of people with a severe mental illness (SMI). Recently, we conducted a pragmatic cluster-randomised controlled trial which evaluated the efects of the one-year Severe Mental Illness Lifestyle Evaluation (SMILE) lifestyle intervention compared with usual care in clients with SMI. The SMILE intervention is a 12-month group-based lifestyle intervention with a focus on increased physical activity and healthy food intake. The aim of the current study was to explore the experiences of people with SMI and healthcare professionals (HCPs) regarding implementation feasibility of the SMILE intervention and the fdelity to the SMILE intervention. Methods: A process evaluation was conducted alongside the pragmatic randomized controlled trial. The experiences of clients and HCPs in the lifestyle intervention group were studied. First, descriptive data on the implementation of the intervention were collected. Next, semi-structured interviews with clients (n=15) and HCPs (n=13) were performed. Interviews were audiotaped and transcribed verbatim. A thematic analysis of the interview data was performed using MAXQDA software. In addition, observations of group sessions were performed to determine the fdelity to the SMILE intervention using a standardised form. Results: Ten out of 26 HCPs who conducted the group sessions discontinued their involvement with the intervention, primarily due to changing jobs. 98% of all planned group sessions were performed. Four main themes emerged from the interviews: 1) Positive appraisal of the SMILE intervention, 2) Suggestions for improvement of the SMILE intervention 3) Facilitators of implementation and 4) Barriers of implementation. Both clients and HCPs had positive experiences regarding the SMILE intervention. Clients found the intervention useful and informative. The intervention was found suitable and interesting for all people with SMI, though HCPs sometimes had to tailor the intervention to individual characteristics of patients (e.g., with respect to cognitive functioning). The handbook of the SMILE intervention was perceived as user-friendly and helpful by HCPs. Combining SMILE with daily tasks, no support from other team members, and lack of staf and time were experienced as barriers for the delivery of the intervention Conclusion: The SMILE intervention was feasible and well-perceived by clients and HCPs. However, we also identifed some aspects that may have hindered efective implementation and needs to be considered when implementing the SMILE intervention in daily practice
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IMPORTANCE People with a severe mental illness (SMI) have a life expectancy reduced by 10 to 20 years compared with the general population, primarily attributable to cardiometabolic disorders. Lifestyle interventions for people with SMI can improve health and reduce cardiometabolic risk. OBJECTIVE To evaluate the effectiveness of a group-based lifestyle intervention among people with SMI in outpatient treatment settings compared with treatment as usual (TAU). DESIGN, SETTING, AND PARTICIPANTS The Severe Mental Illness Lifestyle Evaluation (SMILE) study is a pragmatic cluster randomized clinical trial performed in 8 mental health care centers with 21 flexible assertive community treatment teams in the Netherlands. Inclusion criteria were SMI, age of 18 years or older, and body mass index (calculated as weight in kilograms divided by height in meters squared) of 27 or greater. Data were collected from January 2018 to February 2020, and data were analyzed from September 2020 to February 2023. INTERVENTIONS Weekly 2-hour group sessions for 6 months followed by monthly 2-hour group sessions for another 6 months, delivered by trained mental health care workers. The intervention targeted overall lifestyle changes, emphasizing establishing a healthy diet and promoting physical activity. TAU (control) did not include structured interventions or advice on lifestyle. MAIN OUTCOMES AND MEASURES Crude and adjusted linear mixed models and multivariable logistic regression analyses were performed. The main outcome was body weight change. Secondary outcomes included changes in body mass index, blood pressure, lipid profiles, fasting glucose level, quality of life, self-management ability, and lifestyle behaviors (physical activity and health, mental health, nutrition, and sleep). RESULTS The study population included 11 lifestyle intervention teams (126 participants) and 10 TAU teams (98 participants). Of 224 included patients, 137 (61.2%) were female, and the mean (SD) age was 47.6 (11.1) years. From baseline to 12 months, participants in the lifestyle intervention group lost 3.3 kg (95%CI, −6.2 to −0.4) more than those in the control group. In the lifestyle intervention group, people with high attendance rates lost more weight than participants with medium and low rates (mean [SD] weight loss: high, −4.9 [8.1] kg; medium, −0.2 [7.8] kg; low, 0.8 [8.3] kg). Only small or no changes were found for secondary outcomes. CONCLUSIONS AND RELEVANCE In this trial, the lifestyle intervention significantly reduced weight from baseline to 12 months in overweight and obese adults with SMI. Tailoring lifestyle interventions and increasing attendance rates might be beneficial for people with SMI. TRIAL REGISTRATION Netherlands Trial Register Identifier: NTR6837
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Abstract: Combined lifestyle interventions (CLI) are focused on guiding clients with weight-related health risks into a healthy lifestyle. CLIs are most often delivered through face-to-face sessions with limited use of eHealth technologies. To integrate eHealth into existing CLIs, it is important to identify how behavior change techniques are being used by health professionals in the online and offline treatment of overweight clients. Therefore, we conducted online semi-structured interviews with providers of online and offline lifestyle interventions. Data were analyzed using an inductive thematic approach. Thirty-eight professionals with (n = 23) and without (n = 15) eHealth experience were interviewed. Professionals indicate that goal setting and action planning, providing feedback and monitoring, facilitating social support, and shaping knowledge are of high value to improve physical activity and eating behaviors. These findings suggest that it may be beneficial to use monitoring devices combined with video consultations to provide just-in-time feedback based on the client’s actual performance. In addition, it can be useful to incorporate specific social support functions allowing CLI clients to interact with each other. Lastly, our results indicate that online modules can be used to enhance knowledge about health consequences of unhealthy behavior in clients with weight-related health risks.
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Abstract Background Clients with severe mental illness (SMI) have overall poor physical health. SMI reduces life expectancy by 5–17 years, primarily due to physical comorbidity linked to cardiometabolic risks that are mainly driven by unhealthy lifestyle behaviours. To improve physical health in clients with SMI, key elements are systematic somatic screening and lifestyle promotion. The nurse-led GILL eHealth was developed for somatic screening and the imple‑ mentation of lifestyle activities in clients with SMI. Aims of this study are to evaluate the efectiveness of the GILL eHealth intervention in clients with SMI compared to usual care, and to evaluate the implementation process, and the experiences of clients and healthcare providers with GILL eHealth. Methods The GILL study encompasses a cluster-randomised controlled trial in approximately 20 mental health care facilities in the Netherlands. The randomisation takes place at the team level, assigning clients to the eHealth inter‑ vention or the usual care group. The GILL eHealth intervention consists of two complementary modules for somatic screening and lifestyle promotion, resulting in personalised somatic treatment and lifestyle plans. Trained mental health nurses and nurse practitioners will implement the intervention within the multidisciplinary treatment context, and will guide and support the participants in promoting their physical health, including cardiometabolic risk management. Usual care includes treatment as currently delivered, with national guidelines as frame of reference. We aim to include 258 clients with SMI and a BMI of 27 or higher. Primary outcome is the metabolic syndrome severity score. Secondary outcomes are physical health measurements and participants’ reports on physical activity, perceived lifestyle behaviours, quality of life, recovery, psychosocial functioning, and health-related self-efcacy. Measurements will be completed at baseline and at 6 and 12 months. A qualitative process evaluation will be conducted alongside, to evaluate the process of implementation and the experiences of clients and healthcare professionals with GILL eHealth. Discussion The GILL eHealth intervention is expected to be more efective than usual care in improving physical health and lifestyle behaviours among clients with SMI. It will also provide important information on implementation of GILL eHealth in mental health care. If proven efective, GILL eHealth ofers a clinically useful tool to improve physical health and lifestyle behaviours.
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PURPOSE: To study the preliminary effects and feasibility of the “Traffic Light Method for somatic screening and lifestyle” (TLM) in patients with severe mental illness. DESIGN AND METHODS: A pilot study using a quasi-experimental mixed method design with additional content analyses of lifestyle plans and logbooks. FINDINGS: Significant improvements were found in body weight and waist circumference. Positive trends were found in patients’ subjective evaluations of the TLM. The implementation of the TLM was considered feasible. PRACTICE IMPLICATIONS: The TLM may contribute to a higher quality of care regarding somatic screening and lifestyle training.
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Background: Insufficient amounts of physical activity is a risk factor for (recurrent) stroke. People with a stroke or transient ischemic attack (TIA) have a high risk of recurrent stroke and have lower levels of physical activity than their healthy peers. Though several reviews have looked at the effects of lifestyle interventions on a number of risk factors of recurrent stroke, the effectiveness of these interventions to increase the amounts of physical activity performed by people with stroke or TIA are still unclear. Therefore, the research question of this study was: what is the effect of lifestyle interventions on the level of physical activity performed by people with stroke or TIA? Method: A systematic review was conducted following the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. Pubmed, Embase and Cumulative Index for Nursing and Allied Health Literature (CINAHL), were searched up to August 2018. Randomised controlled trials that compared lifestyle interventions, aimed to increase the amount of physical activity completed by participants with a stroke or TIA, with controls were included. The Physiotherapy Evidence Database (PEDro) score was used to assess the quality of the articles, and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) method for the best evidence synthesis. Results: Eleven trials (n = 2403) met the inclusion criteria. The quality of the trials was mostly high, with 8 (73%) of trials scoring ≥6 on the PEDro scale. The overall best evidence syntheses showed moderate quality evidence that lifestyle interventions do not lead to significant improvements in the physical activity level of people with stroke or TIA. There is low quality evidence that lifestyle interventions that specifically target physical activity are effective at improving the levels of physical activity of people with stroke or TIA. Conclusion: Based on the results of this review, general lifestyle interventions on their own seem insufficient in improving physical activity levels after stroke or TIA. Lifestyle interventions that specifically encourage increasing physical activity may be more effective. Further properly powered trials using objective physical activity measures are needed to determine the effectiveness of such interventions.
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