Application of the SIMPLE Program for Weight Loss at Pathways to Housing: A Feasibility Study
Condition: Obesity; Abdominal Obesity
MeSH terms: Obesity; Obesity, Abdominal
Study type: Interventional

Summary: 
      The objective of this study is to assess feasibility of the application of an adapted
      version, with permission, of Dr. Cenk Tek's Simplified Intervention to Modify Physical
      activity, Lifestyle, and Eating behavior (SIMPLE Program), at Pathways to Housing in Calgary,
      Alberta.

      Dr. Tek and his colleagues reviewed the literature and eloquently summarized how individuals
      with severe mental illness, particularly schizophrenia and schizoaffective disorder are
      disproportionately affected by obesity and its cardio-metabolic sequelae leading to markedly
      reduced longevity and increased healthcare costs. Most new antipsychotic medications, which
      are credited for significant advances in patients' quality of life, appear to induce further
      weight gain, compounding the problem of obesity and related medical morbidity and mortality.
      In addition to the weight gain associated with psychiatric medications, sedentary life style,
      lack of availability of healthy food options, poverty, low level of physical activity,
      cigarette smoking, and inadequate knowledge or understanding of health maintenance, appear to
      contribute to the increased obesity rates and poor health in the severely mentally ill.

      Dr. Tek and colleagues reviewed the available literature on weight loss interventions in
      individuals with severe mental illness. Despite the overwhelming problems related to obesity,
      Dr. Tek's team found that research on obesity interventions for persons with schizophrenia is
      relatively neglected and that there were no treatments that were convincingly shown to be
      effective for weight reduction in this population with unique needs. Sensing a major societal
      gap, they decided to create their own weight loss intervention specifically for individuals
      with severe mental illness. Toward this aim, they collaborated with Dr. Kelly Brownell who
      created the Lifestyle, Exercise, Attitudes, Relationships, and Nutrition or LEARN Program.
      This multi-faceted program is designed to promote positive changes in motivation, attitude
      and deeply ingrained habits that will lead to long lasting weight loss. Brownell's LEARN
      program is a self-directed weight loss program that empowers the user to make lifestyle
      changes. Dr. Tek and his colleagues modified and built upon the program by creating the
      Simplified Intervention to Modify Physical activity, Lifestyle, and Eating behavior or SIMPLE
      program specifically for individuals with severe mental illness
      (http://www.simpleprogram.org/).

      The SIMPLE program is a group weight loss intervention designed for obese patients with
      schizophrenia or schizoaffective disorder. Dr. Tek and his team piloted their modified weight
      loss program and published their findings in 2007. Their preliminary study yielded greater
      weight loss than any of the published randomized controlled trials for a chronic and stable
      schizophrenia sample, and was the only study to show continued weight loss after the
      intervention ended. These early results prompted a new larger randomized controlled trial
      with the largest sample studied to date, an extended period of follow-up, and more detailed
      testing of the effects of weight loss on schizophrenia symptoms, quality of life, and
      laboratory markers of obesity related illness risk over a period of up to 16 months.
      Preliminary results of this trial show significant, sustained weight loss.

      The goal of this study presented for ethics review, is to apply Dr. Tek's 16-week
      intervention to a small group of patients at the Pathways to Housing program in Calgary,
      Alberta. The study coordinator will use Dr. Tek's published manuals, giving full
      acknowledgment to the authors, to create weekly supportive educational sessions for the group
      of patients. Three Pathways to Housing staff members, who regularly create education groups
      for Pathways to Housing patients during a weekly "lifestyle group", will sit in on each
      session. Weight (to calculate BMI) and waist circumference will be measured weekly. There
      will be no control group. The proposed feasibility study is designed to fit seamlessly within
      existing frameworks at Pathways to Housing.

      Upon completion of the study, we will convene a debriefing session with both the participants
      and the three Pathways to Housing staff to learn whether patients found the intervention
      valuable, and whether staff members feel capable of implementing the program on their own
      going forward. If the program is found to be feasible, the materials created will be
      available for future use by the multidisciplinary team at Pathways to Housing.
    


Intervention name(s): simplified intervention to modify physical activity, lifestyle, and eating behavior
Intervention type(s): Behavioral
Intervention description(s): 16 week, behavioural weightloss intervention.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment