search
Back to results

Application of the SIMPLE Program for Weight Loss at Pathways to Housing: A Feasibility Study

Primary Purpose

Obesity, Abdominal Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
simplified intervention to modify physical activity, lifestyle, and eating behavior
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects will be between 18 and 65 years of age.
  2. Have a BMI of 28 or greater
  3. Meet DSM-IV criteria for schizophrenia or schizoaffective disorder
  4. Be on a stable dose of antipsychotic medication for at least one month, with positive symptoms stability as judged by the patient's medical doctors

Exclusion Criteria:

  1. A history of dementia or mental retardation
  2. Not capable of giving informed consent for participation in this study
  3. Ongoing pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SIMPLE weightloss group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Weight
    In Kilograms
    Waist Circumference
    In centimeters from midway between the iliac crest and lower rib
    BMI
    kg/ m squared

    Secondary Outcome Measures

    Full Information

    First Posted
    December 21, 2017
    Last Updated
    January 2, 2018
    Sponsor
    University of Calgary
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03389425
    Brief Title
    Application of the SIMPLE Program for Weight Loss at Pathways to Housing: A Feasibility Study
    Official Title
    Application of the Simplified Intervention to Modify Physical Activity, Lifestyle, and Eating Behavior From Dr. Cenk Tek and Colleagues of Yale University to a Sample of Obese Patients With Stable Schizophrenia or Schizoaffective Disorder on Antipsychotic Medications in the Pathways to Housing Multidisciplinary Care Setting: A Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 19, 2014 (Actual)
    Primary Completion Date
    March 18, 2015 (Actual)
    Study Completion Date
    October 8, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Calgary

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Abdominal Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SIMPLE weightloss group
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    simplified intervention to modify physical activity, lifestyle, and eating behavior
    Intervention Description
    16 week, behavioural weightloss intervention.
    Primary Outcome Measure Information:
    Title
    Weight
    Description
    In Kilograms
    Time Frame
    Weekly for 16 weeks, corresponding with each scheduled intervention group
    Title
    Waist Circumference
    Description
    In centimeters from midway between the iliac crest and lower rib
    Time Frame
    Weekly for 16 weeks, corresponding with each scheduled intervention group
    Title
    BMI
    Description
    kg/ m squared
    Time Frame
    Weekly for 16 weeks, corresponding with each scheduled intervention group

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects will be between 18 and 65 years of age. Have a BMI of 28 or greater Meet DSM-IV criteria for schizophrenia or schizoaffective disorder Be on a stable dose of antipsychotic medication for at least one month, with positive symptoms stability as judged by the patient's medical doctors Exclusion Criteria: A history of dementia or mental retardation Not capable of giving informed consent for participation in this study Ongoing pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vera H Krejcik, MD
    Organizational Affiliation
    University of Calgary
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    http://www.simpleprogram.org/
    Description
    SIMPLE program manuals

    Learn more about this trial

    Application of the SIMPLE Program for Weight Loss at Pathways to Housing: A Feasibility Study

    We'll reach out to this number within 24 hrs