Clinical trial NCT01860131: Self-Management and Educational Support in Extremely Obese Patients Awaiting Bariatric Care
Official title: Evaluating Self-Management and Educational Support in Extremely Obese Patients Awaiting Multidisciplinary Bariatric Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: bariatrics, lifestyle and behavioral modification programs
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Alberta Innovates Health Solutions
name: Alberta Health services
First posted: 2013-05-22
Enrollment: 651
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients achieving 5% weight loss
timeFrame: 9 months
Secondary outcomes:
measure: Clinical outcomes: mean 9-month change in weight
timeFrame: 9 months
measure: blood pressure
timeFrame: 9 months
measure: total cholesterol
timeFrame: 9 months
measure: hemoglobin A1C
timeFrame: 9 months
measure: cardiovascular medications
timeFrame: 9 months
measure: hypertension prevalence
timeFrame: 9 mo
measure: diabetes prevalence
timeFrame: 9 mo
measure: dyslipidemia prevalence
timeFrame: 9 months
Other outcomes:
measure: SF12 quality of life
timeFrame: 9 months
measure: incremental cost-utility
timeFrame: 9 months
measure: Attrition rate from weight management clinic.
timeFrame: 9 months
measure: EQ5D
timeFrame: 9 mon
measure: WEL self efficacy scale
timeFrame: 9 months
measure: readiness to change
timeFrame: 9 months
measure: PHQ-8 depression scale
timeFrame: 9 months
Locations:
city: Edmonton
country: Canada
facility: Alberta Health Services, Edmonton Bariatric Speciality Clinic, Royal Alexandra Hospital
state: Alberta
city: Red Deer
country: Canada
facility: Alberta Health Services, Bariatric Specialty Clinic, Red Deer Regional Hospital
state: Alberta
Study officials:
affiliation: General Internal Medicine and Clinical Pharmacology, University of Alberta
name: Raj Padwal, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Padwal 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.