Quality of Life Outcomes and Economic Impacts of Bariatric Surgery

NCT00850356 | Completed

• 1 other identifier: #B-120208
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Bariatric Surgery; Body Weight; Health care costs; Obesity; Obesity Complications; Prolonged wait times; Quality of Life

Outcome Measures

Primary Outcomes (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)

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

Secondary Outcomes (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.

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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Related Publications (5)

• 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.

  PMID: 22984790 BACKGROUND

• 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.

  PMID: 20932316 BACKGROUND

• 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.

  PMID: 22681857 RESULT

• 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.

  PMID: 25315502 DERIVED

• 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.

  PMID: 24374423 DERIVED

MeSH Terms

Conditions

Obesity; Body Weight

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raj Padwal, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, General Internal Medicine

Study Record Dates

• First Submitted: February 24, 2009
• First Posted: February 25, 2009
• Study Start: November 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 21, 2013

Record last verified: 2013-05

Locations

CA (1)