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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months following the index visit
Awards & highlights

BMI-CDS Trial 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.Check my eligibility
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.See study design
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.

BMI-CDS Trial 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.

BMI-CDS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Intentions to engage in weight loss
Likelihood of patient conversation with their pcc about weight loss

BMI-CDS 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
184 Previous Clinical Trials
3,706,039 Total Patients Enrolled
9 Trials studying Obesity
34,561 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,305,121 Total Patients Enrolled
446 Trials studying Obesity
578,818 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open to individuals over the age of 35 for this research endeavor?

"As per the study's requirements, individuals aged between 18 and 75 are eligible to participate in this trial."

Answered by AI

Can I become part of this clinical investigation?

"This clinical trial calls for volunteers suffering from type 2 diabetes, and aged between 18 to 75. The medical centre is currently seeking enrollment of roughly 10120 individuals."

Answered by AI

What is the current capacity for participants in this clinical experiment?

"Affirmative, the information hosted on clinicaltrials.gov suggests that this medical experiment is in progress and actively recruiting candidates. Its inception was April 19th 2023 with its last update occurring a week later on 4/26/2023. It seeks to recruit an estimated 10120 participants from one location."

Answered by AI

Is this investigation taking on new participants?

"Affirmative. As reflected on clinicaltrials.gov, this study is actively seeking participants; it was initially posted on April 19th 2023 and edited as recently as April 26th 2023. The research team aims to recruit 10120 patients from a single medical centre."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
HealthPartners Medical Group

Why did patients apply to this trial?

Would like to get on a healthy path.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Weight Loss Clinical Decision Support
2023. "Weight Loss Clinical Decision Support". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05198765.
All > Diabetes Type 2
~4048 spots leftby Jan 2025
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