NCT02364128

Brief Summary

At least 15 million Americans are morbidly obese, or more than 100 pounds overweight. Medical treatments including drugs and behavior modification have proven ineffective in producing significant and lasting weight loss in this group. While bariatric surgery is extremely effective for most patients, it also carries risks for both short and long-term complications. There are currently four different types of bariatric surgery available and the risks and benefits of these procedures vary widely and are strongly affected by patient and clinical characteristics. Decision making under these circumstances should reflect informed patient's values and preferences regarding these trade-offs. Instead, the choice of bariatric procedure is more often driven by the beliefs and experiences of the bariatric surgeon that a patient happens to see. Variability in the type of surgery recommended to patients likely results from some combination of surgeons' subjective opinions and personal experiences with regard to the risks and benefits of the treatment options and delegated decision making on the part of patients. The goals of this research proposal are to develop, implement, and evaluate an informed decision support tool for treatment of morbid obesity. This project will be conducted within the context of the Michigan Bariatric Surgery Collaborative (MBSC), which is a statewide clinical registry and quality improvement program that has the participation of virtually every bariatric surgeon and program in the state of Michigan. The MBSC registry now includes externally audited clinical data for more than 80,000 consecutive bariatric surgery patients. MBSC outcome measures include complications occurring within 30 days as well as weight loss, comorbidity resolution, quality of life and satisfaction at 1, 2, and 3 years after bariatric surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

January 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 16, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

4.7 years

First QC Date

January 22, 2015

Last Update Submit

September 25, 2018

Conditions

Morbid ObesityWeight Reduction

Outcome Measures

Primary Outcomes (2)

  • Decision outcome by Decider Guider Questionnaire

    Decisional measures

    24 months

  • Patient specific outcome by Decider Guider Questionnaire

    24 months

Secondary Outcomes (6)

  • Knowledge, as measured by a follow-up Decider Guider questionnaire to test knowledge

    24 months

  • Preferences as measured by Decider Guider Questionnaire

    24 months

  • Weight

    24 months

  • Quality of Life as measured by Decider Guider Questionnaire

    24 months

  • Comorbidity Resolution as measured by Decider Guider Questionnaire

    24 months

  • +1 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Potential bariatric surgery patients who receive both the baseline questionnaire and follow-up questionnaire.

Decision Aid

OTHER

Potential bariatric surgery patients who receive both the baseline questionnaire decision aid/conjoint analysis and follow-up questionnaire.

Behavioral: Decider Guider: Weight Loss

Interventions

Decider Guider: Weight LossBEHAVIORAL

Decision aid tool about weight loss treatment

Decision Aid

Eligibility Criteria

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

You may qualify if:

  • All patients considering undergoing bariatric surgery in the state of Michigan who are 18 or older.
  • All patients, regardless of gender or racial/ethnic background, will be recruited to participate in the study in the same way.

You may not qualify if:

  • Patients under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Obesity, MorbidWeight Loss

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

January 22, 2015

First Posted

February 16, 2015

Study Start

January 1, 2014

Primary Completion

September 15, 2018

Study Completion

September 15, 2018

Last Updated

September 26, 2018

Record last verified: 2018-09

Locations

US(1)