Narrator: Welcome to the E-View Series “Strategies to Integrate Physical Health Care Into Mental Health,” chaired by John W. Newcomer, MD, from the Department of Psychiatry, Washington University School of Medicine in St. Louis, Missouri. This E-View, entitled “Monitoring and Managing Weight Gain in the Mentally Ill,” includes presentations by Rohan Ganguli, MD, and Betty Vreeland MSN, APRN, NP-C, BC.
Dr. Ganguli: So we decided to go into the business of weight reduction. We obviously went out to look for things that had already been done, and we have obviously added to this list since we started out. Even though there are relatively few studies that have some form of a control group, the results were relatively reassuring. All methodologically-rigorous studies found clinically significant weight loss as a result of behavioral interventions, so people with schizophrenia did not seem to be any less suitable for behavioral interventions than other obese or overweight people.
Dr. Ganguli: In developing a behavioral intervention for weight loss in schizophrenia, we had to take into account a lot of the practical difficulties of implementing these interventions in the “real world” as opposed to just with the most enthusiastic providers and the most enthusiastic patients. One of the things that we recognized is that many of our patients do not have control over the quantity of food that they are actually served. They do not actually serve themselves. They do not cook for themselves. They use fast food restaurants like many of the other poor people in this country because it is cheap and tasty. Unfortunately, the only solution to the excessive portion sizes being served is to waste food, so you really have to leave some food behind in order to do that. The same thing with energy—we had to work strategies into their lives where they would waste energy, as well. We also recognized that, to be practical, the intervention had to be cheap, not require education, not require very extensive travel, and should be deliverable by mental health clinicians. The mental health center has way too much on its plate already, so, if there is a significant financial investment, they are not going to be able to do it.
Dr. Ganguli: This is what we came up with: a random assignment, short-term intervention. We did it in groups because this is the most familiar way and the most economical way for mental health centers to deliver treatment. We used standard behavioral treatments. We rehearsed in the groups; we gave them homework to do. A major confound with many of these studies prior to this one was the varieties of medications patients were taking and the potential that treatment was confounded by that. Consequently, for this particular study, we chose a sample of patients who had been switched to risperidone, so basically the medication treatment was uniform across the group. Then we randomized them, and they went into our treatment.
Dr. Ganguli: This is how the 14 weeks were laid out, into 7 separate steps, and you can see that there is a different focus in each of the steps. We manualized the intervention so that we could put it in the hands of the clinicians.
Dr. Ganguli: This was just one top line level of results here. We have taken patients and put them into 3 different strata: those who lost 3% of weight, 4%, or 5%. As you can see, about 50% of the patients would succeed in losing at least up to 4% of body weight. Now, many of them starting out were extremely obese and are still not in the normal healthy range at this point. Nevertheless, in a short-term intervention this is reasonable and compares very favorably with any expensive commercial weight loss program.
Dr. Ganguli: The conclusions reinforced that patients with schizophrenia are in fact capable of participating in these interventions—they do lose weight—and that mental health clinicians delivered the interventions in an efficacious manner. However, I think maintenance of weight loss remains the challenge, as it does for weight loss research in general.
Dr. Ganguli: This is a woman who has really been sick for many years, been treated for many years, and is obviously quite overweight already by the time she volunteers for this study. I think clinically you might have switched your attention off of this lady because she was having difficulty in the beginning and actually lost very little weight to start off with. Then, it picked up a little bit. This is the 2-year follow-up now, and you can see how, even with just the booster sessions every 2 weeks, she continues to lose weight. So, despite this relatively modest initial weight loss, her trajectory of weight loss is really quite good. Also, she has figured out what works for her and what does not. She has gained control of certain things, her eating primarily. She has worked rather diligently at this whole business of wasting energy, and this is one of the things we do encourage our patients to do. Walk down the stairs. Maybe it is too difficult to walk up the stairs. That is fine. Walk down the stairs. Walk down the hill. So, this patient walks down the hill to us.
Dr. Ganguli: Given how difficult it is to lose weight and all the problems that one has once one has gained weight, we turned our attention to the possibility at least of prevention, involving patients with schizophrenia or schizoaffective disorder, starting on a novel antipsychotic—risperidone, olanzapine, quetiapine, ziprasidone or clozapine. Aripiprazole was not readily available at that time. We did take patients with a BMI that was in the obese range but not in the extremely obese range. The reason is that patients who are already obese are quite capable of gaining even more weight when challenged with a weight-gain inducing antipsychotic. We randomized the subjects to the intervention or to usual care, and we followed them up for 16 weeks. Again, this was a relatively short-term intervention, but if you look at the trajectory of weight gain induced by antipsychotics, the patients who are at risk for weight gain will manifest this tendency fairly early on, within the first 6 to 8 weeks.
Dr. Ganguli: Given that this is a preventive intervention, we only wanted to deliver it at the intensity that is required. We broke it down into 4 steps, so if patients went along and were monitored and did not gain weight, then there was nothing further done. However, if patients did gain weight they received the next intervention.
Dr. Ganguli: 1 kilogram is the threshold for the intervention to get stepped up. Here is where we could have gotten into a whole discussion of how many BMI points or what percentage of the initial weight should be the threshold, which would have been extremely difficult for clinicians to implement. So, we said “If you have 1 kilogram of weight gain, you get the next intervention”—very simplistic but easy to implement. Clinicians can easily keep track of things like that. In the example here, Patient 1 gains 1 kilogram at the 9th week, so then he gets to the next level of intervention. He gained another kilogram at the 14th week, so he received 1 more step of the intervention. Patient 2 actually uses up all the steps of the intervention without succeeding in arresting his weight gain.
Dr. Ganguli: This was the average change in weight between the treatment and the control group. The treatment group, as you can see, on average neither gained nor lost weight. This is obviously an extremely insignificant amount of weight loss, a little less than a kilogram. The mean for the control group was to gain about 2 and 3/4 kilograms, which was obviously a statistically significant difference. However, the means are the mean for the whole group: some people gained weight, some people lost weight, and some people did not change in weight.
Dr. Ganguli: This is the proportion of who gained or did not gain weight. This is again reassuring. Obviously we do not help everybody, but with the intervention delivered in a somewhat cost-effective manner, only being triggered by actual weight gain, we are succeeding in preventing some people from gaining weight, it would appear.
Dr. Ganguli: The last piece of data from that study was a little bit more mixed. You cannot treat this in any way statistically for 2 reasons: the numbers are small and, more importantly, people are not randomly assigned to these medications. You can look at the difference in the proportion of patients who gained or who did not gain depending on whether they were in the intervention or the control group. If you look at risperidone and quetiapine, you can see that the intervention groups actually do not gain weight for the most part, whereas the control groups do. If you look at olanzapine and clozapine, you find that there is much less effect of treatment. Are you more successful in your intervention with certain medications than you are with others? This would suggest that that is indeed the case.
Dr. Ganguli: Final conclusions—we did prevent weight gain. The most powerful evidence is for self-monitoring. Instruction combined with self-monitoring actually got you a fairly big bang, and that was a relatively modest investment. The second thing was hints that the treatment might be less successful with some medications than with the others. The implication for the clinician is, with some medicines, you maybe need to switch. With other medicines, you may have behavioral tools that work better for you. Vreeland
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Abbreviations
BID = twice a day
BMI = body weight index
FDA = Food and Drug Administration
LDL = low density lipoprotein
NHLBI = National Heart, Lung, and Blood Institute
USDA = United States Department of Agriculture