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.
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.
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.
Micro and macro algae are a rich source of lipids, proteins and carbohydrates, but also of secondary metabolites like phytosterols. Phytosterols have important health effects such as prevention of cardiovascular diseases. Global phytosterol market size was estimated at USD 709.7 million in 2019 and is expected to grow with a CAGR of 8.7% until 2027. Growing adoption of healthy lifestyle has bolstered demand for nutraceutical products. This is expected to be a major factor driving demand for phytosterols. Residues from algae are found in algae farming and processing, are found as beachings and are pruning residues from underwater Giant Kelp forests. Large amounts of brown seaweed beaches in the province of Zeeland and are discarded as waste. Pruning residues from Giant Kelp Forests harvests for the Namibian coast provide large amounts of biomass. ALGOL project considers all these biomass residues as raw material for added value creation. The ALGOL feasibility project will develop and evaluate green technologies for phytosterol extraction from algae biomass in a biocascading approach. Fucosterol is chosen because of its high added value, whereas lipids, protein and carbohydrates are lower in value and will hence be evaluated in follow-up projects. ALGOL will develop subcritical water, supercritical CO2 with modifiers and ethanol extraction technologies and compare these with conventional petroleum-based extractions and asses its technical, economic and environmental feasibility. Prototype nutraceutical/cosmeceutical products will be developed to demonstrate possible applications with fucosterol. A network of Dutch and African partners will supply micro and macro algae biomass, evaluate developed technologies and will prototype products with it, which are relevant to their own business interests. ALGOL project will create added value by taking a biocascading approach where first high-interest components are processed into high added value products as nutraceutical or cosmeceutical.
Micro and macro algae are a rich source of lipids, proteins and carbohydrates, but also of secondary metabolites like phytosterols. Phytosterols have important health effects such as prevention of cardiovascular diseases. Global phytosterol market size was estimated at USD 709.7 million in 2019 and is expected to grow with a CAGR of 8.7% until 2027. Growing adoption of healthy lifestyle has bolstered demand for nutraceutical products. This is expected to be a major factor driving demand for phytosterols.Residues from algae are found in algae farming and processing, are found as beachings and are pruning residues from underwater Giant Kelp forests. Large amounts of brown seaweed beaches in the province of Zeeland and are discarded as waste. Pruning residues from Giant Kelp Forests harvests for the Namibian coast provide large amounts of biomass. ALGOL project considers all these biomass residues as raw material for added value creation.The ALGOL feasibility project will develop and evaluate green technologies for phytosterol extraction from algae biomass in a biocascading approach. Fucosterol is chosen because of its high added value, whereas lipids, protein and carbohydrates are lower in value and will hence be evaluated in follow-up projects. ALGOL will develop subcritical water, supercritical CO2 with modifiers and ethanol extraction technologies and compare these with conventional petroleum-based extractions and asses its technical, economic and environmental feasibility. Prototype nutraceutical/cosmeceutical products will be developed to demonstrate possible applications with fucosterol.A network of Dutch and African partners will supply micro and macro algae biomass, evaluate developed technologies and will prototype products with it, which are relevant to their own business interests. ALGOL project will create added value by taking a biocascading approach where first high-interest components are processed into high added value products as nutraceutical or cosmeceutical.
