ObesityEVOLUTIONNCT01860131
Self-Management and Educational Support in Extremely Obese Patients Awaiting Bariatric Care
A study testing Weight Wise Community Modules in people with Obesity, run by University of Alberta at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Weight Wise Community Modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 651 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) ≥ 35 kg/m2
- Newly wait-listed for a provincial Weight Wise Adult Clinic
- Adult age ≥ 18 years.
Who cannot join
- Completed more than 4 Weight Wise Community Modules (web-based or group session) in previous 3 months
- Pregnant female
- Unable to read/write/comprehend English
- Unable to access the web
- Unable or unwilling to attend in-person module sessions
- Untreated severe personality disorder, active psychosis, active substance dependence and/or major cognitive impairment
Show all 9Show fewer
- Participation in concurrent trial related to obesity management
- Resides greater than 1 hour driving time to Weight Wise Clinic
- Declined to participate.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Alberta Health Services, Edmonton Bariatric Speciality Clinic, Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Alberta Health Services, Bariatric Specialty Clinic, Red Deer Regional Hospital
Red Deer, Alberta, T4N 4E7
About this study
Official title: Evaluating Self-Management and Educational Support in Extremely Obese Patients Awaiting Multidisciplinary Bariatric Care
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 strategies).A 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.
Read the detailed description
Background:
Extreme obesity (body mass index ≥ 35 kg/m2) 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 clinic.The 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:
- Weight Wise Community Modules delivered in person (9 modules delivered over 10 sessions).
- Weight Wise Community Modules delivered on the web (13 modules, content is similar to the in-person modules)
- Mailed Educational Pamphlets (including Canada's 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 total).Randomization 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 3,6, 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.
- Conditions
- Obesity
- Being tested
- Weight Wise Community Modules
- Keywords
- bariatrics, lifestyle and behavioral modification programs
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Wise Community ModulesBehavioural
Program designed to educate patients regarding proper diet, exercise,and behavioural modification techniques with emphasis on increasing self-management, enhancing self-efficacy and identifying/overcoming barriers to success.
| Study group | Role | What they receive |
|---|---|---|
| Weight Wise Community Modules: Workshops | Active comparator | Groups workshops (10 in total) designed to improve weight management skills and enhance self-efficacy, delivered over 3 months, prior to entering a multidisciplinary bariatric care. Receives: Behavioral: Weight Wise Community Modules |
| Weight Wise Community Modules: Online | Active comparator | Online modules (13 in total) designed to improve weight management skills and enhance self-efficacy, delivered over 3 months, prior to entering a multidisciplinary bariatric care. Receives: Behavioral: Weight Wise Community Modules |
| Educational Written Materials | No intervention | Educational pamphlets about healthy living and tips on self-management strategies. Delivered by mail 3 months prior to entering a multidisciplinary bariatric care. This is minimal intervention and considered the control arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving 5% weight loss
Current consensus guidelines endorse a 5% weight loss to achieve clinically meaningful health benefits after 6-12 months of intervention.
Measured: 9 months
Secondary outcomes (8)
Clinical outcomes: mean 9-month change in weight
kg
Measured: 9 months
blood pressure
mm hg
Measured: 9 months
total cholesterol
mmol/L
Measured: 9 months
hemoglobin A1C
Measured: 9 months
cardiovascular medications
number of medications
Measured: 9 months
hypertension prevalence
Measured: 9 mo
diabetes prevalence
Measured: 9 mo
dyslipidemia prevalence
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Alberta Innovates Health Solutions, Alberta Health services
- Responsible party
- Principal investigator, Raj Padwal, University of Alberta
- Investigators
- Raj Padwal, MD, MSc, Principal investigator, General Internal Medicine and Clinical Pharmacology, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860131
- Sponsor's protocol ID
- CIHR 201200877
- Acronym
- EVOLUTION
- Status last verified
- Mar 2017
- First submitted
- 17 May 2013
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Padwal RS, Sharma AM, Fradette M, Jelinski S, Klarenbach S, Edwards A, Majumdar SR. The evaluating self-management and educational support in severely obese patients awaiting multidisciplinary bariatric care (EVOLUTION) trial: rationale and design. BMC Health Serv Res. 2013 Aug 17;13:321. doi: 10.1186/1472-6963-13-321.
PubMed 24059346Padwal RS, Klarenbach S, Sharma AM, Fradette M, Jelinski SE, Edwards A, Majumdar SR. The evaluating self-management and educational support in severely obese patients awaiting multidisciplinary bariatric care (EVOLUTION) trial: principal results. BMC Med. 2017 Mar 2;15(1):46. doi: 10.1186/s12916-017-0808-6.
PubMed 28249576
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Self-Management and Educational Support in Extremely Obese Patients Awaiting Multidisciplinary Bariatric Care
- ClinicalTrials.gov ID
- NCT01860131
- Acronym / sponsor ID
- EVOLUTION / CIHR 201200877
- Conditions
- Obesity
- Keywords
- bariatrics, lifestyle and behavioral modification programs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Alberta Innovates Health Solutions, Alberta Health services
- Study start
- Mar 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 strategies).A 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 kg/m2) 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 clinic.The 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:
- Weight Wise Community Modules delivered in person (9 modules delivered over 10 sessions).
- Weight Wise Community Modules delivered on the web (13 modules, content is similar to the in-person modules)
- Mailed Educational Pamphlets (including Canada's 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 total).Randomization 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 3,6, 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weight Wise Community Modules: Workshops | Active comparator | Behavioral: Weight Wise Community ModulesGroups workshops (10 in total) designed to improve weight management skills and enhance self-efficacy, delivered over 3 months, prior to entering a multidisciplinary bariatric care. |
| Weight Wise Community Modules: Online | Active comparator | Behavioral: Weight Wise Community ModulesOnline modules (13 in total) designed to improve weight management skills and enhance self-efficacy, delivered over 3 months, prior to entering a multidisciplinary bariatric care. |
| Educational Written Materials | No intervention | –Educational pamphlets about healthy living and tips on self-management strategies. Delivered by mail 3 months prior to entering a multidisciplinary bariatric care. This is minimal intervention and considered the control arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) ≥ 35 kg/m2
- Newly wait-listed for a provincial Weight Wise Adult Clinic
- Adult age ≥ 18 years.
Key exclusion criteria (9 listed)
- Completed more than 4 Weight Wise Community Modules (web-based or group session) in previous 3 months
- Pregnant female
- Unable to read/write/comprehend English
- Unable to access the web
- Unable or unwilling to attend in-person module sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight Wise Community ModulesProgram designed to educate patients regarding proper diet, exercise,and behavioural modification techniques with emphasis on increasing self-management, enhancing self-efficacy and identifying/overcoming barriers to success. | Behavioural | Weight Wise Community Modules: Online, Weight Wise Community Modules: Workshops |
Primary outcome
Proportion of patients achieving 5% weight loss
Time frame: 9 months
Current consensus guidelines endorse a 5% weight loss to achieve clinically meaningful health benefits after 6-12 months of intervention.
8 secondary outcomes
Clinical outcomes: mean 9-month change in weight
Time frame: 9 months
blood pressure
Time frame: 9 months
total cholesterol
Time frame: 9 months
hemoglobin A1C
Time frame: 9 months
cardiovascular medications
Time frame: 9 months
hypertension prevalence
Time frame: 9 mo
diabetes prevalence
Time frame: 9 mo
dyslipidemia prevalence
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Background: PubMed 24059346Padwal RS, Sharma AM, Fradette M, Jelinski S, Klarenbach S, Edwards A, Majumdar SR. The evaluating self-management and educational support in severely obese patients awaiting multidisciplinary bariatric care (EVOLUTION) trial: rationale and design. BMC Health Serv Res. 2013 Aug 17;13:321. doi: 10.1186/1472-6963-13-321.
- Results publication: PubMed 28249576Padwal RS, Klarenbach S, Sharma AM, Fradette M, Jelinski SE, Edwards A, Majumdar SR. The evaluating self-management and educational support in severely obese patients awaiting multidisciplinary bariatric care (EVOLUTION) trial: principal results. BMC Med. 2017 Mar 2;15(1):46. doi: 10.1186/s12916-017-0808-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raj Padwal, MD, MSc principal investigator
General Internal Medicine and Clinical Pharmacology, University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Wise Community Modules in people with Obesity, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving 5% weight loss (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01860131, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.