NEW YORK ― A simple, easy-to-use, free program appears to stop antipsychotic-related weight gain and delivers durable weight loss in patients with schizophrenia, new research shows.
A randomized controlled trial showed that the Simplified Intervention to Modify Physical activity, Lifestyle, and Eating behavior (SIMPLE) program resulted in clinically significant weight loss of 5% or more with no postintervention weight gain out to 6 months compared with usual care.
"One out of 4 people lost over 5%, or roughly 10 lbs of weight, and they kept it off for 6 months without any intervention, which was amazing," principal investigator Cenk Tek, MD, director of the psychosis program at the Connecticut Mental Health Center, Yale School of Medicine in New Haven, told Medscape Medical News.
The study was presented here at the American Psychiatric Association's 2014 Annual Meeting.
Serious Health Threat
Weight gain, said Dr. Tek, is common in patients with severe mental illness and presents a serious health threat and clinical challenge.
Research shows that the obesity rate in this patient population is 4 to 5 times greater than in the general population for a variety of reasons, including metabolic changes related to use of second-generation antipsychotics. He noted that approximately 40% of patients with schizophrenia are taking second-generation antipsychotics and that about half of them have diabetes.
"The problem of overweight and obesity in these patients has always been there, but it was accentuated after the introduction of new generation of antipsychotic medications, which caused an incredible amount of weight gain," said Dr. Tek.
He noted, for example, that patients with first-episode psychosis experience a doubling of cardiovascular risk in the first year of illness. Research by Dr. Tek's group suggests that some of this risk may be related to factors related to schizophrenia itself, but "an important part of it is related to weight gain."
"There is no other disease where you have a doubling of cardiovascular risk in the first year. This is a critical period in the disease that requires intervention, so physicians really need to know what they are prescribing and, if at all possible, start with lower weight gain liability agents," said Dr. Tek.
Dr. Tek also noted that weight gain is one of the key reasons individuals with schizophrenia stop taking antipsychotic medications.
To help patients with schizophrenia lose weight, the investigators developed the SIMPLE program, which is tailored to the unique needs and challenges of this patient population, including cognitive, educational, and social problems observed in schizophrenia.
Previously tested in a proof-of-concept study in individuals without schizophrenia, the tenets of SIMPLE include rule simplicity, frequent repetition, cognitive-behavioral techniques, a food reimbursement program, and in situ grocery shopping education, all of which take place in a group setting.
"We took basic weight loss and standardized concepts and simplified them as much as possible ― we simplified the wording as much as possible, and we introduced a lot of repetition ― so essentially, you repeat, repeat, repeat to reinforce the concepts," said Dr. Tek.
"The supermarket environment is very cluttered, so what we do is teach people how to navigate the supermarket, how to calculate the calories and read labels," he added.
One of the biggest hurdles, said Dr. Tek, is the high cost of healthy food, so patients are taught strategies such as purchasing frozen vegetables, which are nutritionally equivalent to their fresh counterparts but are much less expensive. They are also taught how to prepare and cook foods in a healthy manner.
In addition, he said, the SIMPLE program incorporates a contingency management component. In a previous study by Dr Tek's group, patients were rewarded for attending the program, for losing weight, or for behavior change. Rewarding behavior change by reimbursing patients for purchasing healthy foods on the basis of their grocery receipts proved to be more effective, and this approach was incorporated into the SIMPLE study.
To test the program's impact on weight loss in this population, the investigators conducted a 16-week randomized controlled trial of SIMPLE compared with usual care (TAU) in patients attending a community mental health center.
A total of 137 men and women aged 18 to 70 years with a diagnosis of schizophrenia or schizoaffective disorder who were taking antipsychotic medications and whose body mass index was 28 or greater were randomly assigned in a 2 to 1 ratio to receive SIMPLE or TAU.
Easiest Weight to Lose
Study results revealed that the SIMPLE group lost significantly more weight (2.14 kg; 95% confidence interval [CI], 1.10 - 3.17) than the TAU group (0.61 kg; 95% CI, 0.44 - 1.65). In addition, significantly more patients in the SIMPLE group lost more than 5% of body weight compared with those in the TAU group ― 25% vs 7%, respectively.
In addition, said Dr. Tek, SIMPLE participants successfully maintained their weight loss with no additional intervention for 6 months.
Although pleased with the study results, Dr. Tek noted that the "easiest weight to lose is the weight you never gain," and he cautioned physicians to be highly selective about which antipsychotics they prescribe.
"If at all possible, do not prescribe an antipsychotic, but if you do, be familiar with the side effect profile of specific agents you chose and their potential for weight gain," he said.
The SIMPLE program is ready for prime time, and physicians can access it by visiting www.simpleprogram.org.
Commenting on the findings for Medscape Medical News, Donna T. Anthony, MD, PhD, program director for the Psychotic Disorders Continuum at New York-Presbyterian Hospital in Westchester, said that one of the major strengths of the study was its "real-world" design and practical patient management approach.
Antipsychotic-related weight gain, she added, is a "serious problem.... "Unfortunately, some of the most effective antipsychotics tend to have the highest risk of weight gain and other metabolic effects," she said.
Medication adherence, she said, is crucial to good, long-term outcomes, but, like Dr. Tek, she pointed out that weight gain often gets in the way of optimal treatment.
"I'm impressed with the study. I think it's crucial to come at the problem of antipsychotic-related weight gain from many different angles, and this study takes into account some of the very practical issues and challenges that patients with schizophrenia and schizoaffective disorder face," she said.
The study was funded by the National Institute of Mental Health. Dr. Tek and Dr. Anthony report no relevant financial relationships.
American Psychiatric Association's 2014 Annual Meeting Abstract 153. Presented May 6, 2014.
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Cite this: 'Simple' Solution to Antipsychotic-Related Weight Gain - Medscape - May 29, 2014.