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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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 Background: People with severe mental illness (SMI) often suffer from long-lasting symptoms that negatively influence their social functioning, their ability to live a meaningful life, and participation in society. Interventions aimed at increasing physical activity can improve social functioning, but people with SMI experience multiple barriers to becoming physically active. Besides, the implementation of physical activity interventions in day-to-day practice is difficult. In this study, we aim to evaluate the effectiveness and implementation of a physical activity intervention to improve social functioning, mental and physical health. Methods: In this pragmatic stepped wedge cluster randomized controlled trial we aim to include 100 people with SMI and their mental health workers from a supported housing organization. The intervention focuses on increasing physical activity by implementing group sports activities, active guidance meetings, and a serious game to set physical activity goals. We aim to decrease barriers to physical activity through active involvement of the mental health workers, lifestyle courses, and a medication review. Participating locations will be divided into four clusters and randomization will decide the start of the intervention. The primary outcome is social functioning. Secondary outcomes are quality of life, symptom severity, physical activity, cardiometabolic risk factors, cardiorespiratory fitness, and movement disturbances with specific attention to postural adjustment and movement sequencing in gait. In addition, we will assess the implementation by conducting semi-structured interviews with location managers and mental health workers and analyze them by direct content analysis. Discussion: This trial is innovative since it aims to improve social functioning in people with SMI through a physical activity intervention which aims to lower barriers to becoming physically active in a real-life setting. The strength of this trial is that we will also evaluate the implementation of the intervention. Limitations of this study are the risk of poor implementation of the intervention, and bias due to the inclusion of a medication review in the intervention that might impact outcomes. Trial registration: This trial was registered prospectively in The Netherlands Trial Register (NTR) as NTR NL9163 on December 20, 2020. As the The Netherlands Trial Register is no longer available, the trial can now be found in the International Clinical Trial Registry Platform via: https:// trial search. who. int/ Trial2. aspx? Trial ID= NL9163.
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