Morbid ObesityNCT01149512

Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program

An observational study of Morbid 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

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Morbid Obesity
How many people: 178 participants
Where: 1 siteCanada
Study dates: Sep 2011to Sep 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.

Who may be able to join

All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.

Who cannot join

Patients who have undergone selection for surgery outside this process, or who have had surgery elsewhere.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Center for the Advancement of Minimally Invasive Surgery & Weight Wise Program
Edmonton, Alberta, T5H 3V9

Other trials in Canada

About this study

The majority of data documenting the outcomes for the adjustable gastric band (LAGB) originate from non-publicly funded surgical centres. The investigators aim to investigate the clinical outcomes of LAGB from a publicly funded Canadian obesity management program. This program recognized obesity as a chronic disease, providing extensive pre-operative multidisciplinary assessment and long term patient follow-up. Patients are selected for surgical management carefully by a multidisciplinary team and the LAGB is presented as one option to surgical management. Further, the investigators will investigate the operational impacts, including direct and indirect costs related the LAGB, to determine long term impacts on publicly funded hospitals within Canada.

Conditions: Morbid Obesity
Medical subject headings: Obesity, Morbid

What participants receive

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

Study groups in NCT01149512
Study group	Role	What they receive
LAGB patients in Weight Wise Program		All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.

What is being measured

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

Mean Percentage Total Body Weight Loss
the percent total body weight loss between Baseline and 1 year the percent total body weight loss between Baseline and 2 years the percent total body weight loss between Baseline and 3 years
Measured: baseline to 1 year, baseline to 2 years, baseline to 3 years

Secondary outcomes (1)

% of Excess Body Weight Loss
the percent of excess body weight loss between Baseline and 1 year the percent of excess body weight loss between Baseline and 2 years the percent of excess body weight loss between Baseline and 3 years
Measured: baseline to 1 year, baseline to 2 years, baseline to 3 years

Timeline

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

Sep 2011Sep 2011

First posted23 Jun 2010 (estimated)
Study startSep 2011
Primary completionSep 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Morbid ObesityStudies of the same condition, open and under way.
More trials run by University of AlbertaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 178 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01149512
Sponsor's protocol ID: Pro00014271
Status last verified: Aug 2017
First submitted: 21 Jun 2010
Last updated: 11 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program
ClinicalTrials.gov ID: NCT01149512
Acronym / sponsor ID: Pro00014271
Conditions: Morbid Obesity
Study type: Observational
Recruitment status: Completed
Enrolment: 178 participants (actual)
Lead sponsor: University of AlbertaUniversity, hospital or other
Collaborators: Alberta Health services
Study start: Sep 2011
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 23 Jun 2010 (estimated)
Results: Posted 7 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
LAGB patients in Weight Wise Program	–	–All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.

Key inclusion criteria (1 listed)

All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.

Key exclusion criteria (1 listed)

Patients who have undergone selection for surgery outside this process, or who have had surgery elsewhere.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Mean Percentage Total Body Weight Loss
Time frame: baseline to 1 year, baseline to 2 years, baseline to 3 years
the percent total body weight loss between Baseline and 1 year the percent total body weight loss between Baseline and 2 years the percent total body weight loss between Baseline and 3 years

1 secondary outcome

% of Excess Body Weight Loss
Time frame: baseline to 1 year, baseline to 2 years, baseline to 3 years

Results and safety

Results posted to the registry on 7 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LAGB Patients in Weight Wise Program	178	178

Primary outcome: Mean Percentage Total Body Weight Loss

Time frame: baseline to 1 year, baseline to 2 years, baseline to 3 years. Mean (Standard Deviation). Unit: % of total body weight loss

Measure	LAGB Patients in Weight Wise Program n = 175
Baseline to 1 year	15.8 (7.6)
Baseline to 2 years	20.7 (11)
Baseline to 3 years	20.3 (10)

Population analysed: Three patients' weight data were not included in the weight loss analysis owing to early removal of band (n = 1) and complication or pregnancy affecting weight (n = 2) before 1-year follow-up. 79 patients reached 2 year follow up time point and 38 patients reached 3 year follow up time point.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3-year follow-up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LAGB Patients in Weight Wise Program	0 of 178 (0%)	50 of 178 (28.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Morbid Obesity

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Morbid 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 1 inclusion and 1 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 11 Sep 2017. 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?

Yes. Results are posted in the registry (first posted 7 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Percentage Total Body Weight Loss (time frame: baseline to 1 year, baseline to 2 years, baseline to 3 years). 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 NCT01149512.

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 11 Sep 2017.