Ignite Creation Date:
2024-05-06 @ 1:40 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01860131
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2013-05-17
Brief Title:
Self-Management and Educational Support in Extremely Obese Patients Awaiting Bariatric Care
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Evaluating Self-Management and Educational Support in Extremely Obese Patients Awaiting Multidisciplinary Bariatric Care
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVOLUTION
Brief Summary:
Extreme obesity is present in 9 of the Canadian population Extremely obese people have a high chance of developing health problems and dying early Our national guidelines recommend that extremely obese individuals receive multidisciplinary treatment meaning that a number of specialized care providers should be available to help administer obesity treatments to these patients
The investigators oversee a large obesity program called the Weight Wise Obesity Program which delivers multidisciplinary care at 5 sites in Alberta Canada Edmonton Calgary Grand Prairie Medicine Hat Red Deer Wait times to enter the Weight Wise clinics range from a few months to three years depending on the site in Alberta The investigators performed a survey of the patients on the wait list in Edmonton and discovered that they self- report extremely poor health and feel that the long wait times are partly responsible for this poor health To try to support these patients as they wait for multidisciplinary care the investigators designed a group based self-management intervention consisting of Weight Wise Community Modules Patients attend this program over three months to receive weight management education diet exercise stress management coping strategiesA web-based version of the modules is also available
The investigators wish to determine if these modules delivered to patients prior to entering the clinic help to reduce weight improve quality of life in the wait listed patients and also to see if going through the modules helps patients to be more ready for weight management when they reach the Weight Wise clinic The investigators also wish to examine whether or not these modules are cost effective If these modules are not useful a more effective way to support wait listed patients will be sought
The investigators oversee a large obesity program called the Weight Wise Obesity Program which delivers multidisciplinary care at 5 sites in Alberta Canada Edmonton Calgary Grand Prairie Medicine Hat Red Deer Wait times to enter the Weight Wise clinics range from a few months to three years depending on the site in Alberta The investigators performed a survey of the patients on the wait list in Edmonton and discovered that they self- report extremely poor health and feel that the long wait times are partly responsible for this poor health To try to support these patients as they wait for multidisciplinary care the investigators designed a group based self-management intervention consisting of Weight Wise Community Modules Patients attend this program over three months to receive weight management education diet exercise stress management coping strategiesA web-based version of the modules is also available
The investigators wish to determine if these modules delivered to patients prior to entering the clinic help to reduce weight improve quality of life in the wait listed patients and also to see if going through the modules helps patients to be more ready for weight management when they reach the Weight Wise clinic The investigators also wish to examine whether or not these modules are cost effective If these modules are not useful a more effective way to support wait listed patients will be sought
Detailed Description:
Background
Extreme obesity body mass index 35 kgm2 affects 9 of Canadians has tripled in prevalence in 3 decades shortens life expectancy by 5-13 years and is debilitating and costly Current guidelines recommend that extremely obese patients receive treatment consisting of intensive lifestyle modification bariatric obesity surgery within a multidisciplinary bariatric setting However in Canada and other publicly funded health care settings demand for multidisciplinary bariatric care far outstrips the capacity to provide it and so patients often face protracted multiyear wait times A recent study examining 150 patients on the Edmonton wait list done at a time when the wait was several years in Edmonton demonstrated that these patients self-report severely impaired health status similar to those with diabetes or COPD and strongly feel that prolonged wait times are a major contributor to their health impairments To support these patients as they wait for more definitive management our multidisciplinary team of clinicians allied health professionals and decision makers have designed and implemented a Weight Wise Community Module WWCM program consisting of a 3-month 10-session group-based weight self-management intervention In addition a web-based version of the WWCM is now available The WWCM program teaches self-management skills to improve diet increase physical activity reduce stress and increase self-efficacy - but it has not yet been evaluated We are interested both in the outcomes after three months and after the patient has gone through the weight management clinicThe comparative clinical and cost-effectiveness of the in-person WWCM web-based WWCM and usual care are not known
Objectives
To determine if an evidence-based weight-management program currently being delivered to adult age 18 years or greater extremely obese patients wait-listed for multidisciplinary bariatric obesity care in a population-based program improves clinical and humanistic outcomes and is cost-effective
Study Design
This 9-month study will use a pragmatic prospective randomized controlled design in which consenting extremely obese patients newly wait listed for the Weight Wise Adult Clinic will be randomly assigned one of three groups
1 Weight Wise Community Modules delivered in person 9 modules delivered over 10 sessions
2 Weight Wise Community Modules delivered on the web 13 modules content is similar to the in-person modules
3 Mailed Educational Pamphlets including Canadas Guide to Health Living and tips on self-management strategies and improving readiness-to-change
Each study arm will be comprised of 220 patients 660 totalRandomization will be performed independently of the research team by an independent organization the EPICORE Centre
Procedures
Patients will be enrolled at the point of referral to each zonal program They will have 3 months to complete the modules or review the mailed educational materials After this they will enter the weight management clinic in their zone They will be followed by the study team for an additional six months while they are in the weight management clinic Study outcomes assessments will occur at 36 and 9-months post randomization If patients undergo bariatric surgery during the follow-up period data will still be collected but they may need to be censored in the analysis
Extreme obesity body mass index 35 kgm2 affects 9 of Canadians has tripled in prevalence in 3 decades shortens life expectancy by 5-13 years and is debilitating and costly Current guidelines recommend that extremely obese patients receive treatment consisting of intensive lifestyle modification bariatric obesity surgery within a multidisciplinary bariatric setting However in Canada and other publicly funded health care settings demand for multidisciplinary bariatric care far outstrips the capacity to provide it and so patients often face protracted multiyear wait times A recent study examining 150 patients on the Edmonton wait list done at a time when the wait was several years in Edmonton demonstrated that these patients self-report severely impaired health status similar to those with diabetes or COPD and strongly feel that prolonged wait times are a major contributor to their health impairments To support these patients as they wait for more definitive management our multidisciplinary team of clinicians allied health professionals and decision makers have designed and implemented a Weight Wise Community Module WWCM program consisting of a 3-month 10-session group-based weight self-management intervention In addition a web-based version of the WWCM is now available The WWCM program teaches self-management skills to improve diet increase physical activity reduce stress and increase self-efficacy - but it has not yet been evaluated We are interested both in the outcomes after three months and after the patient has gone through the weight management clinicThe comparative clinical and cost-effectiveness of the in-person WWCM web-based WWCM and usual care are not known
Objectives
To determine if an evidence-based weight-management program currently being delivered to adult age 18 years or greater extremely obese patients wait-listed for multidisciplinary bariatric obesity care in a population-based program improves clinical and humanistic outcomes and is cost-effective
Study Design
This 9-month study will use a pragmatic prospective randomized controlled design in which consenting extremely obese patients newly wait listed for the Weight Wise Adult Clinic will be randomly assigned one of three groups
1 Weight Wise Community Modules delivered in person 9 modules delivered over 10 sessions
2 Weight Wise Community Modules delivered on the web 13 modules content is similar to the in-person modules
3 Mailed Educational Pamphlets including Canadas Guide to Health Living and tips on self-management strategies and improving readiness-to-change
Each study arm will be comprised of 220 patients 660 totalRandomization will be performed independently of the research team by an independent organization the EPICORE Centre
Procedures
Patients will be enrolled at the point of referral to each zonal program They will have 3 months to complete the modules or review the mailed educational materials After this they will enter the weight management clinic in their zone They will be followed by the study team for an additional six months while they are in the weight management clinic Study outcomes assessments will occur at 36 and 9-months post randomization If patients undergo bariatric surgery during the follow-up period data will still be collected but they may need to be censored in the analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None