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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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 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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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: 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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To analyze the intervention components, levels of influence, explicit use of theory, and conditions for sustainability of currently used lifestyle interventions within lifestyle approaches aiming at physical activity and nutrition in healthcare organizations supporting people with Intellectual Disabilities (ID).
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Rationale: While combined lifestyle interventions have multiple health benefits, their impact on the oral microbiome is not known. We explored the effects of a lifestyle intervention including protein drink on the oral microbiome in older adults with obesity and type 2 diabetes (T2D).Methods: In a post-hoc analysis of the PROBE study, 87 subjects (66.5±6.1 years, 33% female) with tongue dorsum samples at baseline and week 13 were included. All subjects participated in a 13-week lifestyle intervention with exercise (3x/week) and hypocaloric diet (-600 kcal/day), and had been randomized to receive a test product (21g whey protein enriched with leucine and vitamin D) or isocaloric control (0g protein) 10x/week. T2D was subtyped as muscle insulin resistance (MIR, n=34) or no-MIR (n=36) based on available muscle insulin sensitivity index. Microbiome was analysed by V4 16s rDNA sequencing. Diversity, measured as species richness and Shannon diversity index, was statistically analysed with paired (within group) and independent (between groups) samples t-test.Results: displayed below. Conclusion: Consuming a whey protein drink enriched with leucine and vitamin D during a combined lifestyle intervention increased species richness of the oral microbiome in obese T2D subjects with muscle insulin resistance.
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Background Having a partner is associated with better prognosis in patients with cardiovascular disease. However, the influence of partners on modification of patients’ lifestyle-related risk factors (LRFs) is unclear. Therefore, we studied the influence of partners and the level of partner participation on LRF modification in patients after an acute coronary syndrome (ACS) or revascularization. Methods The RESPONSE-2 trial was a community-based lifestyle intervention trial comparing nurse-coordinated referral to a comprehensive set of lifestyle interventions (physical activity, weight reduction and/or smoking cessation) to usual care. In the current analysis, we investigated the association of having a partner on the improvement in >1 LRF without deterioration in other LRFs at 12 months follow-up. Secondary, the influence of the level of partner participation (participating partner, non-participating partner and no partner) in the intervention group was studied. Results In total 824 individuals (411 intervention, 413 control) were included in the analysis. The presence of a partner was comparable in both groups (intervention 74%, control 69%). In the intervention group, 48% of partners participated in the lifestyle interventions. Overall, having a partner was positively associated with improvement in LRFs (odds ratio (OR) 2.57 (95% confidence interval (CI) 1.57 – 4.21), p<0.001). In the intervention group, having a participating partner was also positively associated with improvement in LRFs compared to patients without a partner (OR 2.45 95% CI 1.25 – 4.79, p=0.009). When analysed the influence of partners on LRFs separately, patients with a participating partner were most successful in reducing weight compared to patients without a partner (OR 2.71 95% CI 1.16 – 6.36, p=0.02). Conclusion Having a partner is associated with improvement on LRFs in patients after ACS or revascularization. Moreover, patients with participating partners in the lifestyle programs were most successful in LRF modification. Involvement of partners in lifestyle interventions should be considered in routine practice.
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The combination of self-tracking and persuasive eCoaching in healthy lifestyle interventions is a promising approach. The objective of this study is to map the key components of existing healthy lifestyle interventions combining self-tracking and persuasive eCoaching using the scoping review methodology in accordance with the York methodological framework by Arksey and O’Malley. Seven studies were included in this preliminary scoping review. Components related to persuasive eCoaching applied only in effective interventions were reduction of complex behavior into small steps, providing positive motivational feedback by praise and providing reliable information to show expertise. Concerning self-tracking, it did not seem to matter if more action was required by the participant to obtain personal data. The first results of this study indicate the necessity to identify the needs and problems of the specific target group of the interventions, due to differences found between various groups of users. In addition to objective data on lifestyle and health behavior, other factors need to be taken into account, such as the context of use, daily experiences, and feelings of the users.
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Unhealthy lifestyle behaviours are common among vocational students and increase their risk of non-communicable diseases later in life. Unfortunately, only a limited number of school-based healthy lifestyle interventions have been developed for vocational students. Moreover, there is no evidence that these interventions are effective. They have often been developed by professionals without involving students and therefore may not align with the target group’s perceptions and needs. We used a participatory design approach to develop an intervention to promote healthy physical activity and dietary behaviours, in co-creation with vocational students. ‘Contextmapping’ was used to assess student conscious and subconscious motivation for a healthy lifestyle (n = 27, ages 17-26 years). All sessions and interviews were recorded and transcribed. The transcripts were analysed using framework analysis. Contextual characteristics that influenced student lives were their peers, family and short-term motives like earning money, being cool and looking good. In addition, they often had a passive attitude towards daily life, were unaware of their health illiteracy and being healthy was a goal for the distant future. These findings led to four design concepts that converged in a peer-led healthy lifestyle intervention that includes a social media campaign and activities to demonstrate and practice specific health behaviours among vocational students.
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