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Self-Management and Educational Support in Extremely Obese Patients Awaiting Bariatric Care

Evaluating Self-Management and Educational Support in Extremely Obese Patients Awaiting Multidisciplinary Bariatric Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01860131
Acronym
EVOLUTION
Enrollment
651
Registered
2013-05-22
Start date
2013-03-31
Completion date
2016-03-31
Last updated
2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

bariatrics, lifestyle and behavioral modification programs

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 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: 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 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.

Interventions

BEHAVIORALWeight Wise Community Modules

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.

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Alberta Innovates Health Solutions
CollaboratorOTHER
Alberta Health services
CollaboratorOTHER
University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Body mass index (BMI) ≥ 35 kg/m2 2. Newly wait-listed for a provincial Weight Wise Adult Clinic 3. Adult age ≥ 18 years.

Exclusion criteria

1. Completed more than 4 Weight Wise Community Modules (web-based or group session) in previous 3 months 2. Pregnant female 3. Unable to read/write/comprehend English 4. Unable to access the web 5. Unable or unwilling to attend in-person module sessions 6. Untreated severe personality disorder, active psychosis, active substance dependence and/or major cognitive impairment 7. Participation in concurrent trial related to obesity management 8. Resides greater than 1 hour driving time to Weight Wise Clinic 9. Declined to participate.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients achieving 5% weight loss9 monthsCurrent consensus guidelines endorse a 5% weight loss to achieve clinically meaningful health benefits after 6-12 months of intervention.

Secondary

MeasureTime frameDescription
blood pressure9 monthsmm hg
Clinical outcomes: mean 9-month change in weight9 monthskg
total cholesterol9 monthsmmol/L
hemoglobin A1C9 months
cardiovascular medications9 monthsnumber of medications
hypertension prevalence9 mo
diabetes prevalence9 mo
dyslipidemia prevalence9 months

Other

MeasureTime frameDescription
Attrition rate from weight management clinic.9 months
EQ5D9 montotal score
WEL self efficacy scale9 monthstotal score
readiness to change9 monthsvisual analogue score
PHQ-8 depression scale9 monthstotal score
incremental cost-utility9 months$Cdn/QALY
SF12 quality of life9 monthstotal and domain scores

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026