Gail L. Daumit

Comparative Effectiveness of Weight-Loss Interventions in Clinical Practice

BACKGROUND Obesity and its cardiovascular complications are extremely common medical problems, but evidence on how to accomplish weight loss in clinical practice is sparse. METHODS We conducted a randomized, controlled trial to examine the effects of two behavioral weight-loss interventions in 415 obese patients with at least one cardiovascular risk factor. Participants were recruited from six primary care practices; 63.6% were women, 41.0% were black, and the mean age was 54.0 years. One intervention provided patients with weight-loss support remotely--through the telephone, a study-specific Web site, and e-mail. The other intervention provided in-person support during group and individual sessions, along with the three remote means of support. There was also a control group in which weight loss was self-directed. Outcomes were compared between each intervention group and the control group and between the two intervention groups. For both interventions, primary care providers reinforced participation at routinely scheduled visits. The trial duration was 24 months. RESULTS At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) for all participants was 36.6, and the mean weight was 103.8 kg. At 24 months, the mean change in weight from baseline was -0.8 kg in the control group, -4.6 kg in the group receiving remote support only (P<0.001 for the comparison with the control group), and -5.1 kg in the group receiving in-person support (P<0.001 for the comparison with the control group). The percentage of participants who lost 5% or more of their initial weight was 18.8% in the control group, 38.2% in the group receiving remote support only, and 41.4% in the group receiving in-person support. The change in weight from baseline did not differ significantly between the two intervention groups. CONCLUSIONS In two behavioral interventions, one delivered with in-person support and the other delivered remotely, without face-to-face contact between participants and weight-loss coaches, obese patients achieved and sustained clinically significant weight loss over a period of 24 months. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT00783315.).

Obesity Among Those with Mental Disorders: A National Institute of Mental Health Meeting Report

The National Institute of Mental Health convened a meeting in October 2005 to review the literature on obesity, nutrition, and physical activity among those with mental disorders. The findings of this meeting and subsequent update of the literature review are summarized here. Levels of obesity are higher in those with schizophrenia and depression, as is mortality from obesity-related conditions such as coronary heart disease. Medication side effects, particularly the metabolic side effects of antipsychotic medications, contribute to the high levels of obesity in those with schizophrenia, but increased obesity and visceral adiposity have been found in some but not all samples of drug-naïve patients as well. Many of the weight-management strategies used in the general population may be applicable to those with mental disorders, but little is known about the effects of these strategies on this patient population or how these strategies may need to be adapted for the unique needs of those with mental disorders. The minimal research on weight-management programs for those with mental disorders indicates that meaningful changes in dietary intake and physical activity are possible. Physical activity is an important component of any weight-management program, particularly for those with depression, for which a substantial body of research indicates both mental and physical health benefits. Obesity among those with mental disorders has not received adequate research attention, and empirically-based interventions to address the increasing prevalence of obesity and risk of cardiovascular and metabolic diseases in this population are lacking.

Physical activity patterns in adults with severe mental illness.

Although physical inactivity is a leading cause of death and the Surgeon General recommends regular moderate physical activity, many Americans are inactive. Because of their increased burden of obesity and diabetes, people with severe mental illness (SMI) especially may benefit from physical activity, yet little is known about the prevalence and types of physical activity in people with SMI. We surveyed outpatients with schizophrenia and affective disorders at two psychiatric centers in Maryland and compared physical activity patterns to an age-gender-race-matched national sample (National Health and Nutrition Examination Survey III) of the general population. We found that people with SMI are overall less physically active than the general population, although the proportion with recommended physical activity levels was equal. The participants with SMI were more likely to walk as their sole form of physical activity. Within the SMI group, those without regular social contact and women had higher odds of being inactive.

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 systematically 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 randomly 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 randomization, 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 ClinicalTrials.gov number, NCT00902694.).

Change in metabolic syndrome parameters with antipsychotic treatment in the CATIE Schizophrenia Trial: Prospective data from phase 1

BACKGROUND The metabolic syndrome (MS) is associated with increased risk for diabetes mellitus and coronary heart disease, and is highly prevalent among schizophrenia patients. Given concerns over antipsychotic metabolic effects, this analysis explored MS status and outcomes in phase 1 of the CATIE Schizophrenia Trial. METHODS The change in proportion of subjects with MS and individual criteria was compared between antipsychotic treatment groups, along with mean changes for individual criteria. Primary analyses examined subjects with fasting laboratory assessments at baseline and 3 months. Other analyses examined 3-month changes in MS status, waist circumference (WC), HDL cholesterol and blood pressure in all subjects, metabolic changes at the end of phase 1 participation (EOP), and repeated measures changes in HDL, blood pressure (BP) and WC over phase 1. RESULTS At 3 months, there were no significant between-drug differences for the change in proportion of subjects meeting MS status or individual MS criteria in the smaller fasting cohort (n = 281) or for those meeting criteria for parameters not dependent on fasting status (BP, HDL, WC) among all subjects (n=660). Among all subjects whose MS status could be determined at 3 months (n=660), MS prevalence increased for olanzapine (from 34.8% to 43.9%), but decreased for ziprasidone (from 37.7% to 29.9%) (p=.001). Although effect sizes varied across subgroups, at 3 months olanzapine and quetiapine had the largest mean increase in waist circumference (0.7 in. for both) followed by risperidone (0.4 in.), compared to no change for ziprasidone (0.0 in.) and a decrease in waist circumference for perphenazine (-0.4 in.). Olanzapine also demonstrated significantly different changes in fasting triglycerides at 3 months (+21.5 mg/dl) compared to ziprasidone (-32.1 mg/dl). EOP exposure data was obtained, on average, nine months from baseline for all metabolic variables. Results from EOP and repeated measures analyses were consistent with those at 3 months for mean changes in WC and fasting triglycerides, but between group differences emerged for HDL and SBP. CONCLUSIONS This large non-industry sponsored study confirms the differential metabolic effects between antipsychotics. Clinicians are advised to monitor all metabolic parameters, including WC, HDL and serum triglycerides, during antipsychotic treatment.

Antipsychotic effects on estimated 10-year coronary heart disease risk in the CATIE schizophrenia study.

OBJECTIVE Persons with schizophrenia die earlier than the general population, in large part due to cardiovascular disease. The study objective was to examine effects of different antipsychotic treatments on estimates of 10-year coronary heart disease (CHD) risk calculated by the Framingham Heart Study formula. METHOD Change in 10-year risk for CHD was compared between treatment groups in 1125 patients followed for 18 months or until treatment discontinuation in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Schizophrenia Trial. RESULTS The covariate-adjusted mean change in 10-year CHD risk differed significantly between treatments. Olanzapine was associated with a 0.5% (SE 0.3) increase and quetiapine, a 0.3% (SE 0.3) increase; whereas risk decreased in patients treated with perphenazine, -0.5% (SE 0.3), risperidone, -0.6% (SE 0.3), and ziprasidone -0.6% (SE 0.4). The difference in 10-year CHD risk between olanzapine and risperidone was statistically significant (p=0.004). Differences in estimated 10-year CHD risk between drugs were most marked in the tertile of subjects with a baseline CHD risk of at least 10%. Among individual CHD risk factors used in the Framingham formula, only total and HDL cholesterol levels differed between treatments. CONCLUSIONS These results indicate that the impact on 10-year CHD risk differs significantly between antipsychotic agents, with olanzapine producing the largest elevation in CHD risk of the agents studied in CATIE.

An Evidence-Based Review of Patient-Centered Behavioral Interventions for Hypertension

INTRODUCTION While behavioral interventions may be viewed as important strategies to improve blood pressure (BP), an evidence-based review of studies evaluating these interventions may help to guide clinical practice. METHODS We employed systematic review and meta-analysis of the literature (1970-1999) to assess the independent and additive effects of three behavioral interventions on BP control (counseling, self-monitoring of BP, and structured training courses). RESULTS Of 232 articles assessing behavioral interventions, 15 (4072 subjects) evaluated the effectiveness of patient-centered counseling, patient self-monitoring of BP, and structured training courses. Pooled results revealed that counseling was favored over usual care (3.2 mmHg [95% CI, 1.2-5.3] improvement in diastolic blood pressure [DBP] and 11.1 mmHg [95% CI, 4.1-18.1] improvement in systolic blood pressure [SBP]) and training courses (10 mmHg improvement in DBP [95% CI, 4.8-15.6]). Counseling plus training was favored over counseling (4.7 mmHg improvement in SBP [95% CI, 1.2-8.2]) and afforded more subjects hypertension control (95% [95% CI, 87-99]) than those receiving counseling (51% [95% CI, 34-66]) or training alone (64% [95% CI, 48-77]). CONCLUSIONS Evidence suggests that counseling offers BP improvement over usual care, and that adding structured training courses to counseling may further improve BP. However, there is not enough evidence to conclude whether self-monitoring of BP or training courses alone offer consistent improvement in BP over counseling or usual care. The magnitude of BP reduction offered by counseling indicates this may be an important adjunct to pharmacologic therapy.

Prevalence and correlates of obesity in a community sample of Individuals with severe and persistent mental illness

Individuals with severe and persistent mental illness (SPMI) have a preponderance of weight problems, possibly even greater than the obesity epidemic in the general population. Although atypical antipsychotics cause weight gain, their contribution to obesity has not been characterized in a community setting where individuals may take multiple psychotropics associated with weight gain. Using survey information including measured height and weight from a random sample of Maryland Medicaid recipients with SPMI, we compared obesity prevalence to the National Health and Nutrition Examination Survey (NHANES III) sample and a Maryland sample (Behavioral Risk Factor Surveillance System) of the general population adjusted to SPMI demographic characteristics. We investigated correlates of obesity in the SPMI sample. The results indicate that both men and especially women with SPMI had a higher prevalence of obesity than the general population; this portends substantial health implications. A fourfold association between atypical antipsychotics and prevalent obesity was found in men but not in women; further work should clarify mechanisms of obesity in the SPMI.

Characteristics of primary care visits for individuals with severe mental illness in a national sample

Individuals with severe mental illness (SMI) are at risk for inadequate general medical and preventive care, but little is known about their visits for primary care. We performed a cross-sectional analysis of primary care physician visits from the National Ambulatory Medical Care Survey (NAMCS) 1993-1998 and compared visit characteristics for patients with and without SMI. SMI was defined from ICD-9 diagnoses and medications. Primary care visits for patients with SMI were more likely to be return visits, were longer, and were more likely to have scheduled follow-up than for patients without SMI. Obesity, diabetes, and smoking were reported approximately twice as frequently in visits for patients with SMI compared to patients without SMI. The percent of visits with preventive counseling and counseling targeted at chronic medical conditions was similar for both groups. Likely appropriate to their complex needs, patients with SMI using primary care tend to have more return visits, longer time with the physician and are more often scheduled for follow-up care; their preventive counseling appears similar to non-SMI visits.

Excess mortality in persons with severe mental disorders: a multilevel intervention framework and priorities for clinical practice, policy and research agendas

Excess mortality in persons with severe mental disorders (SMD) is a major public health challenge that warrants action. The number and scope of truly tested interventions in this area remain limited, and strategies for implementation and scaling up of programmes with a strong evidence base are scarce. Furthermore, the majority of available interventions focus on a single or an otherwise limited number of risk factors. Here we present a multilevel model highlighting risk factors for excess mortality in persons with SMD at the individual, health system and socio‐environmental levels. Informed by that model, we describe a comprehensive framework that may be useful for designing, implementing and evaluating interventions and programmes to reduce excess mortality in persons with SMD. This framework includes individual‐focused, health system‐focused, and community level and policy‐focused interventions. Incorporating lessons learned from the multilevel model of risk and the comprehensive intervention framework, we identify priorities for clinical practice, policy and research agendas.