NCT01860131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
651

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

3 years

First QC Date

May 17, 2013

Last Update Submit

March 30, 2017

Conditions

Obesity

Keywords

bariatrics, lifestyle and behavioral modification programs

Outcome Measures

Primary Outcomes (1)

  • 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.

    9 months

Secondary Outcomes (8)

  • Clinical outcomes: mean 9-month change in weight

    9 months

  • blood pressure

    9 months

  • total cholesterol

    9 months

  • hemoglobin A1C

    9 months

  • cardiovascular medications

    9 months

  • +3 more secondary outcomes

Other Outcomes (7)

  • SF12 quality of life

    9 months

  • incremental cost-utility

    9 months

  • Attrition rate from weight management clinic.

    9 months

  • +4 more other outcomes

Study Arms (3)

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.

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.

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.

Interventions

Weight Wise Community ModulesBEHAVIORAL

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.

Weight Wise Community Modules: OnlineWeight Wise Community Modules: Workshops

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • Participation in concurrent trial related to obesity management
  • Resides greater than 1 hour driving time to Weight Wise Clinic
  • Declined to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alberta Health Services, Edmonton Bariatric Speciality Clinic, Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Alberta Health Services, Bariatric Specialty Clinic, Red Deer Regional Hospital

Red Deer, Alberta, T4N 4E7, Canada

Location

Related Publications (2)

  • 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.

    PMID: 24059346BACKGROUND

  • 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.

    PMID: 28249576RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Raj Padwal, MD, MSc

    General Internal Medicine and Clinical Pharmacology, University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

May 17, 2013

First Posted

May 22, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

CA(2)