SAN FRANCISCO – Patients with serious mental illness who are overweight or obese can lose weight and keep it off with a multifaceted behavioral intervention, a randomized trial showed.
This was one of the conclusions reached by Dr. Gail L. Daumit, lead investigator of ACHIEVE (Randomized Trial of Achieving Healthy Lifestyles in Psych Rehabilitation).
In the trial, Dr. Daumit and her associates tested a physical activity and diet modification intervention among nearly 300 overweight or obese adults attending psychiatric rehabilitation programs. After 18 months, the trial’s intervention group had lost an average of 3.2 kg more than the control group. Moreover, the intervention group continued to lose weight throughout the study period.
"Despite many challenges, with a tailored lifestyle intervention, overweight and obese adults with a serious mental illness can make lifestyle changes and achieve substantial weight loss," Dr. Daumit said while presenting the data at the annual meeting of the American Psychiatric Association. "Our findings really support implementation of a targeted behavioral weight-loss intervention in this high-risk population."
Results of the study were published recently in the New England Journal of Medicine (2013;368:1594-1602).
Dr. Daumit, associate professor of medicine at Johns Hopkins University, Baltimore, said that her findings both resembled and differed from those seen in the PREMIER trial, which tested a behavioral intervention among otherwise healthy individuals with prehypertension or mild hypertension (Ann. Intern. Med. 2006;144:485-95).
In that trial, the intervention group had a similar 2.7-kg greater weight loss than the control group. The PREMIER intervention group, however, had dramatic early weight loss followed by weight gain, whereas the ACHIEVE intervention group continued to lose weight at a more moderate pace throughout the trial.
Dr. Daumit speculated that the trials’ differing trajectories of weight loss might have resulted from the ACHIEVE patients taking more time to engage in their intervention.
"We recruited really all comers, so that in order to get into this trial, you didn’t have to be anywhere on the readiness-for-change spectrum. ... So it may have taken them then more time to make the behavioral changes. But once they made the changes, they were able to keep them," she said. "And maybe there is some limited choice in this population.
"Maybe there were some cognitive issues where they just kind of made the decision and they then just went down that path. They may have less disposable income, [and] less choice about alternatives."
As analyses were conducted according to intention to treat, patients were included even if they never attended a single session, Dr. Daumit pointed out.
"Not everyone came to sessions. So I guess the question is, ‘What’s the dose that’s needed to achieve [weight loss]?’ We are doing some kind of on-treatment analyses now where we are trying to see how much attendance was related to how much weight loss," she said.
One person who attended the session asked what kind of feedback the investigators had received from the trial participants.
"We are still in the process of trying to talk to them about that," Dr. Daumit said. "I think they definitely really liked the exercise ... and that trying to involve more social supports, they believe, would have been more helpful."
Another person in attendance asked how much cardiovascular risk reduction Dr. Daumit thinks was achieved with the weight loss.
"Our study was not powered for this," Dr. Daumit said. However, there were nonsignificant trends whereby the intervention group had roughly 5 mg/dL reductions in total and low-density lipoprotein cholesterol and glucose levels, and a 2-cm reduction in waist circumference, compared with those in the control group.
"Many participants were already taking statins and blood pressure medications and diabetes medications – this wasn’t like just a virgin untreated population," Dr. Daumit said. "So it was difficult to sort out" the intervention effect.
Dr. Daumit also expressed concern about failure of policymakers to include people with serious mental illness in their thinking, particularly in light of this population’s prevalence of overweight and obesity.
"Historically, interventions for cardiovascular disease risk reduction, including weight loss trials with tens of millions of dollars of funding by the [National Institutes of Health] for the overall population, have systematically excluded almost all mental health consumers," she noted. "All of the large trials that really kind of define our nutrition policy or other health behavior intervention policies in the U.S. exclude this population."
The 291 patients in the ACHIEVE trial were recruited from 10 Maryland psychiatric rehabilitation programs that offered meals and encouraged attendance at least twice a week. Those with an active alcohol or substance abuse disorder were excluded.