BMI-CDS for Obesity and Type 2 Diabetes
(BMI-CDS Trial)

Recruiting in Palo Alto (17 mi)

Overseen byPatrick J O'Connor, MD, MPH, MA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: HealthPartners Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

Despite steady increases in obesity prevalence, the more than 12 million obese U.S. adults with type 2 diabetes (T2DM) and severe obesity encounter a number of barriers to adopting effective surgical and pharmaceutical treatments, including: (a) both patients and primary care clinicians frequently underestimate the effectiveness and potential benefits of obesity treatments; and (b) both patients and clinicians typically lack access to evidence-based estimates of the patient-specific potential benefits and risks of appropriate obesity treatment options. This project addresses these important obstacles to evidence-based obesity care by providing accurate, patient-specific estimates of benefits and risks of various obesity treatment options to inform shared decision making about obesity treatment. In this project the study team will implement a scalable, web-based point-of-care decision-support intervention in primary care that provides patient-specific estimates of obesity treatment benefits and risks in a randomized trial in 40 primary care clinics with 15,810 eligible patients, and assess intervention impact on (i) appropriate active management of obesity in eligible patients, (ii) weight trajectories, and (iii) patient and clinician satisfaction with the decision support intervention.

Research Team

Patrick J O'Connor, MD, MPH, MA

Principal Investigator

HealthPartners Institute

Eligibility Criteria

This trial is for adults aged 18-75 with obesity and type 2 diabetes, having a BMI of 35 or higher. They must have had an appointment at one of the study clinics during the accrual period. It's not open to pregnant or breastfeeding individuals, those with cancer (except non-melanoma skin cancer), dementia, cirrhosis, or those in long-term care.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

Have an index clinical encounter with a PCC (family practice or general internal medicine physician, nurse practitioner, or physician assistant) at a randomized study clinic during a 12-month accrual period

I am between 18 and 75 years old.

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Exclusion Criteria

History of a previous Modified Barium Swallow (MBS) procedure.

I have been diagnosed with cancer, dementia, or cirrhosis, excluding non-melanoma skin cancer.

Pregnant or breastfeeding

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Treatment Details

Interventions

BMI-CDS (Behavioral Intervention)

Trial OverviewThe trial tests a web-based decision-support tool called BMI-CDS designed to help patients and doctors make informed choices about obesity treatments. The impact on weight management, patient satisfaction, and clinician satisfaction will be measured across different primary care clinics.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: BMI-CDSExperimental Treatment1 Intervention

Clinicians and their patients assigned to intervention clinics will receive shared decision support tools for weight loss management.

Group II: Usual CareActive Control1 Intervention

Clinicians and their patients assigned to control clinics will engage in the usual standard of care.