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Behavioral Intervention

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

N/A
Waitlist Available
Led By Patrick J O'Connor, MD MPH MA
Research Sponsored by HealthPartners Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Existing diagnosis of T2DM
Adults (age 18-75 years at index clinical encounter)
Must not have
Patients diagnosed with cancer (except non-melanoma skin cancer), dementia, and/or cirrhosis
In long-term care, palliative care, or hospice care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months following the index visit
Awards & highlights

Summary

This trial seeks to improve treatment of obesity for 12 million US adults with type 2 diabetes, by providing patient-specific estimates of benefits & risks of treatment options to inform shared decision making.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Since this intervention involves information provision rather than medication or surgery, traditional side effects are not expected. However, there may be psychological impacts from discussing weight management options.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with type 2 diabetes.
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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with cancer, dementia, or cirrhosis, excluding non-melanoma skin cancer.
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I am in long-term, palliative, or hospice care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months following the index visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months following the index visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in weight trajectory during 18-month post-intervention follow-up period
Number of new prescriptions of an FDA-approved pharmaceutical for obesity management
Proportion of patients referred to an MBS program
Secondary study objectives
Intentions to engage in weight loss
Likelihood of patient conversation with their pcc about weight loss

Trial Design

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.

Find a Location

Who is running the clinical trial?

HealthPartners InstituteLead Sponsor
191 Previous Clinical Trials
3,711,537 Total Patients Enrolled
9 Trials studying Obesity
34,561 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,314,771 Total Patients Enrolled
459 Trials studying Obesity
579,430 Patients Enrolled for Obesity
Patrick J O'Connor, MD MPH MAPrincipal InvestigatorHealthPartners Institute

Media Library

BMI-CDS (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05198765 — N/A
Obesity Research Study Groups: BMI-CDS, Usual Care
Obesity Clinical Trial 2023: BMI-CDS Highlights & Side Effects. Trial Name: NCT05198765 — N/A
BMI-CDS (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05198765 — N/A
~1518 spots leftby Jan 2025
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