AzTrials
AzTrials

ObesityNCT00850356

Quality of Life Outcomes and Economic Impacts of Bariatric Surgery

An observational study of Obesity, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose is to determine the economic, clinical and quality of life outcomes of bariatric surgery and describe the consequences of protracted wait-times (~ 2 years) for this procedure. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity
How many people
500 participants
Where
1 siteCanada
Study dates
Nov 2008to Aug 2012
Phase
Observational
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Three participant goups (n=500:) Bariatric Surgery(Sx):150 participants. Patients approved for bariatric surgery in an Adult Weight Management Clinic (AWMC) will be eligible (BMI ≥35 kg/m2 and a major medical comorbidity or BMI ≥ 40 kg/m2). Contraindications to surgery are pregnancy, unstable psychiatric disease, patients deemed too medically high-risk, age > 60 years, active substance abuse, or an active eating disorder. Medical Treatment(Mx):200 participants. Patients will be approached for the study upon their first visit in the AWMC. Both medical and surgical patients receive intensive lifestyle counseling (diets, exercise, behavioral modification) delivered according to current recommendations. Other than receiving extra education about surgery and post-operative diets, there is no difference in care between the medical and surgical arms. Community Wait-List Control(Wx):150 participants will be enrolled from the list of newly referred patients to the AWMC.

Who may be able to join

  • 18-60 years old
  • Male and Female
  • BMI Levels greater than or equal to 35 kg/m2 and a major medical comorbidity OR BMI levels greater than or equal to 40 kg/m2
  • Able to provide written informed consent

Who cannot join

  • Pregnant or nursing
  • Previously enrolled in this study (e.g Community Control Arm)
  • Currently participating in a clinical trial
  • Individual expected to have difficulty with follow-up visits, completion of questionnaires, etc.
  • Any contraindications to bariatric surgery and/or anti-obesity medical treatment
  • Ability and willingness to complete questionnaires.
  • Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the study protocol.
  • Patients in whom protein sparing very low calorie diet therapy is planned.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

Other trials in Canada

About this study

Official title: Alberta Population-based, Prospective Evaluation of the Quality of Life Outcomes and Economic Impacts of Bariatric Surgery

The purpose is to determine the economic, clinical and quality of life outcomes of bariatric surgery and describe the consequences of protracted wait-times (~ 2 years) for this procedure.

Read the detailed description

Severe obesity affects approximately 3% of Canadians (nearly 1 million people) and is becoming increasingly common and costly. Surgery for severe obesity, known as bariatric surgery, substantially reduces weight and the risk of death, decreases obesity-related health problems and increases quality of life. However, surgery carries a 0.5-2% up-front risk of death, has potentially serious short and long-term complications, and an uncertain cost-to-benefit ratio. Surgery is becoming increasingly popular, programs are being initiated or expanded across the country, and waiting lists are several years long. Provincial governments, unable to keep pace with surgical demand, are sending patients to the US for surgery and patients are petitioning governments for increased access to care.

By collecting data from a clinical obesity program that services an entire Canadian health region of over 1 million people and linking these data to provincial and regional data sources, this study aims to:

  1. Determine whether surgery improves 2-yr medical and patient-centered outcomes (such as quality of life, satisfaction, and others) compared to both medical and community wait-list control patients;
  2. Comprehensively compare the 3-yr costs of surgical and non-surgical care;
  3. Determine the impact of 2-yr wait times for surgery on patient health and wellness, including quality of life and patient satisfaction.

This study will provide essential data to accurately determine the benefits, risks, and costs of bariatric surgery in the Canadian context for patients, care providers, and decision makers. Equally important, it will determine whether the health and quality of life of Canadians waiting for surgery is adversely affected because of extended wait-times. Results will directly influence and streamline patient care, will be applicable to similar programs across the country, and serve as an important foundation for future research and data collection.

Conditions
Obesity
Keywords
Bariatric Surgery, Body Weight, Health care costs, Obesity, Obesity Complications, Prolonged wait times, Quality of Life
Medical subject headings
Obesity, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00850356
Study groupRoleWhat they receive
Bariatric Surgery Patient (Sx)Participants who are patients in an Adult Weight Management Clinic (AWMC) and undergo bariatric surgery.
Medical Treamtent (Mx)Participants who are patients in the same AWMC as above and are currently undergoing a medical treatment program that includes intensive lifestyle counseling (diets, exercise, behavioral modification).
Wait-List (Wx)Participants who are on the Wait-List for the AWMC, and waiting to undergo medical treatment program and/or bariatric surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of life measured through responses to standardized health questionnaires: SF-12; EQ-5D; IWQoL(Impact of Weight on Quality of Life); PSS(Patient satisfaction survey); Mod WLIQ:(Modified Waiting-list impact questionnaire)

    Measured: Every Six months for 2 years (At time =0, 6, 12, 18, 24 months)

Secondary outcomes (1)

  1. Comprehensive comparison of the 3-yr costs of surgical and non-surgical care through medication logs, a questionnaire package, and accessing Alberta health and Wellness data.

    Measured: Every six months for 2 years (At time =0, 6, 12, 18, 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2009 (estimated)
  2. Study startNov 2008
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00850356
Sponsor's protocol ID
#B-120208
Status last verified
May 2013
First submitted
24 Feb 2009
Last updated
21 May 2013
Results posted
No

Publications

  • Padwal RS, Chang HJ, Klarenbach S, Sharma AM, Majumdar SR. Characteristics of the population eligible for and receiving publicly funded bariatric surgery in Canada. Int J Equity Health. 2012 Sep 18;11:54. doi: 10.1186/1475-9276-11-54.

    PubMed 22984790

  • Padwal RS, Majumdar SR, Klarenbach S, Birch DW, Karmali S, McCargar L, Fassbender K, Sharma AM. The Alberta population-based prospective evaluation of the quality of life outcomes and economic impact of bariatric surgery (APPLES) study: background, design and rationale. BMC Health Serv Res. 2010 Oct 8;10:284. doi: 10.1186/1472-6963-10-284.

    PubMed 20932316

  • Padwal RS, Majumdar SR, Klarenbach S, Birch DW, Karmali S, McCargar L, Fassbender K, Sharma AM. Health status, quality of life, and satisfaction of patients awaiting multidisciplinary bariatric care. BMC Health Serv Res. 2012 Jun 8;12:139. doi: 10.1186/1472-6963-12-139.

    PubMed 22681857

  • Warkentin LM, Majumdar SR, Johnson JA, Agborsangaya CB, Rueda-Clausen CF, Sharma AM, Klarenbach SW, Karmali S, Birch DW, Padwal RS. Weight loss required by the severely obese to achieve clinically important differences in health-related quality of life: two-year prospective cohort study. BMC Med. 2014 Oct 15;12:175. doi: 10.1186/s12916-014-0175-5.

    PubMed 25315502

  • Padwal RS, Rueda-Clausen CF, Sharma AM, Agborsangaya CB, Klarenbach S, Birch DW, Karmali S, McCargar L, Majumdar SR. Weight loss and outcomes in wait-listed, medically managed, and surgically treated patients enrolled in a population-based Bariatric program: prospective cohort study. Med Care. 2014 Mar;52(3):208-15. doi: 10.1097/MLR.0000000000000070.

    PubMed 24374423

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by University of Alberta at 1 site 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 4 inclusion and 8 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 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Quality of life measured through responses to standardized health questionnaires: SF-12; EQ-5D; IWQoL(Impact of Weight on Quality of Life); PSS(Patient satisfaction survey); Mod WLIQ:(Modified Waiting-list impact questionnaire) (time frame: Every Six months for 2 years (At time =0, 6, 12, 18, 24 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 NCT00850356, which also lists 5 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 21 May 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in