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10120 Participants Needed

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

Overseen ByHeidi L Ekstrom, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Disqualifiers: Cancer, Dementia, Cirrhosis, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment BMI-CDS for obesity and type 2 diabetes?

Research on obesity treatments shows that significant weight loss can improve health and quality of life, especially in severe obesity cases. Multimodal programs focusing on behavior change have shown promising results in reducing body weight and improving related health issues.¹ ² ³ ⁴ ⁵

Is BMI-CDS safe for humans?

The safety of BMI-CDS specifically isn't mentioned, but similar treatments like orlistat have been found to be safe and well-tolerated in studies, with no serious adverse events reported. However, some new anti-obesity medications have raised safety concerns, so it's important to consider individual risk factors and consult with a healthcare provider.⁶ ⁷ ⁸ ⁹ ¹⁰

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

You have a body mass index (BMI) of 35 or higher.

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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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of a web-based point-of-care decision-support intervention in primary care clinics

18 months

Regular visits as per primary care schedule

Follow-up

Participants are monitored for changes in weight trajectory and other outcomes

18 months

Treatment Details

Interventions

BMI-CDS

Trial Overview 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.

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Surgical weight loss procedures significantly improve or resolve obesity-related medical issues for most patients, but the long-term effects on sustained weight loss and health improvements are still uncertain.

The American Society of Bariatric Surgery's new computer registry aims to standardize outcome analysis and improve patient selection for surgeries, which could enhance the effectiveness of weight loss interventions and ultimately improve health outcomes for morbidly obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of obesity surgery.Brolin, RE.[2005]

Roux-en-Y gastric bypass (RYGB) in patients with class I obesity (BMI 30.0-34.9 kg/m²) and type 2 diabetes resulted in significant weight loss (BMI decreased from 34.6 to 25.8 kg/m²) and improved glycemic control (HbA1c decreased from 8.2% to 6.1%) after one year, while the nonsurgical control group showed no significant changes.

Patients who underwent RYGB also reduced their use of antihypertensive and antihyperlipidemia medications, although this may have contributed to persistent high blood pressure and LDL cholesterol levels, indicating a need for careful medication management post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of bariatric surgery and nonsurgical therapy in adults with type 2 diabetes mellitus and body mass indexSerrot, FJ., Dorman, RB., Miller, CJ., et al.[2022]

A one-year multimodal treatment program for severe obesity (BMI≥35.0 kg/m²) involving 190 participants showed significant improvements in body weight, waist circumference, eating disorder psychopathology, and quality of life from pre-treatment to post-treatment, with benefits maintained at a one-year follow-up.

Despite the promising results of the program, high rates of participant drop-out during the study limit the ability to draw strong conclusions, highlighting the need for further evaluations to strengthen the evidence base.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the One-Year Multimodal Weight Loss Program DOC WEIGHT® 1.0 for Obesity Class II and III].Rudolph, A., Hellbardt, M., Baldofski, S., et al.[2019]