Discussion The proposed core outcome set will provide clear guidance about what outcomes should be measured , as a minimum , in trials of interventions for people with coexisting type-2 diabetes and SMI , and improve future synthesis of trial evidence in this area .
Background People with diabetes and comorbid severe mental illness ( SMI ) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone .
There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities .
However , there is a lack of consensus about which outcomes are important for this comorbid population , with trials differing in their focus on physical and mental health .
A core outcome set , which includes outcomes across both conditions that are relevant to patients and other key stakeholders , is needed .
A behavioral weight-loss intervention in persons with serious mental illness.
BACKGROUND Overweight and obesity are epidemic among persons with serious mental illness , yet weight-loss trials systematic ally exclude this vulnerable population . Lifestyle interventions require adaptation in this group because psychiatric symptoms and cognitive impairment are highly prevalent . Our objective was to determine the effectiveness of an 18-month tailored behavioral weight-loss intervention in adults with serious mental illness . METHODS We recruited overweight or obese adults from 10 community psychiatric rehabilitation outpatient programs and r and omly assigned them to an intervention or a control group . Participants in the intervention group received tailored group and individual weight-management sessions and group exercise sessions .  Weight change was assessed at 6 , 12 , and 18 months . RESULTS Of 291 participants who underwent r and omization , 58.1 % had schizophrenia or a schizoaffective disorder , 22.0 % had bipolar disorder , and 12.0 % had major depression . At baseline , the mean body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 36.3 , and the mean weight was 102.7 kg ( 225.9 lb ) . Data on weight at 18 months were obtained from 279 participants . Weight loss in the intervention group increased progressively over the 18-month study period and differed significantly from the control group at each follow-up visit . At 18 months , the mean between-group difference in weight ( change in intervention group minus change in control group ) was -3.2 kg ( -7.0 lb , P=0.002 ) ; 37.8 % of the participants in the intervention group lost 5 % or more of their initial weight , as compared with 22.7 % of those in the control group ( P=0.009 ) . There were no significant between-group differences in adverse events . CONCLUSIONS A  behavioral weight-loss intervention significantly reduced weight over a period of 18 months in overweight and obese adults with serious mental illness . Given the epidemic of obesity and weight-related disease among persons with serious mental illness , our findings support implementation of targeted behavioral weight-loss interventions in this high-risk population . ( Funded by the National Institute of Mental Health ; ACHIEVE Clinical Trials.gov number , NCT00902694 . )
Discussion The proposed core outcome set will provide clear guidance about what outcomes should be measured , as a minimum , in trials of interventions for people with coexisting type-2 diabetes and SMI , and improve future synthesis of trial evidence in this area .
Background People with diabetes and comorbid severe mental illness ( SMI ) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone .
There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities .
However , there is a lack of consensus about which outcomes are important for this comorbid population , with trials differing in their focus on physical and mental health .
A core outcome set , which includes outcomes across both conditions that are relevant to patients and other key stakeholders , is needed .