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
About this trial
This is an interventional treatment trial for Obesity
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
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
NCT ID
NCT03389425
First Posted
December 21, 2017
Last Updated
January 2, 2018
Sponsor
University of Calgary
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
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