Diabetes Mellitus, Type 2WL-CDSNCT05198765
Weight Loss Clinical Decision Support
A study testing BMI-CDS in people with Diabetes Mellitus, Type 2 and Obesity, run by HealthPartners Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- BMI-CDS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,120 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age 18-75 years at index clinical encounter)
- Existing diagnosis of T2DM
- BMI ≥35 kg/m2 at index clinical encounter
- 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
Who cannot join
- Prior MBS
- Patients diagnosed with cancer (except non-melanoma skin cancer), dementia, and/or cirrhosis.
- Pregnant or breastfeeding.
- In long-term care, palliative care, or hospice care.
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Medical Group
Minneapolis, Minnesota, 55440
About this study
Official title: Reducing Clinical Inertia in Obesity Management of Diabetes Patients in Primary Care: Cluster-Randomized 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.
Read the detailed description
Obesity has been steadily increasing in prevalence and now affects more than 4 in 10 U.S. adults, leading to many adverse health outcomes including myocardial infarction, stroke, type 2 diabetes (T2DM), hypertension, sleep apnea, arthritis, and others. Effective surgical, pharmaceutical, and behavioral treatments for obesity are available, and the evidence to support the broad use of these treatments for obesity is very well established. However, active management of obesity defined as prescribing or referring adults with obesity for lifestyle, pharmaceutical, or surgical treatment of obesity, is greatly underused. Major underlying reasons for underutilization of effective obesity treatments include: (a) both patients and primary care clinicians (PCCs) frequently underestimate the effectiveness and potential benefits of obesity treatments; and (b) both patients and clinicians typically lack access to evidence-based, patient-specific estimates of the potential benefits and risks of appropriate patient-specific obesity treatment options.
To address this problem, the study team will integrate externally validated prediction equations that estimate benefits and risk of various obesity treatment options in adults with T2DM into a widely-used and successful clinical decision support system in order to deliver appropriate patient-specific obesity treatment suggestions at the point of care. The team will implement a scalable, web-based point-of-care decision-support intervention in a randomized trial in 40 primary care clinics with 15,810 eligible patients, and assess intervention impact on the following primary outcomes: (a) appropriate referral of eligible patients for evaluation for metabolic bariatric surgery (MBS); (b) appropriate initiation of FDA-approved medications for weight loss; (c) weight trajectories; and (d) patient-reported conversations with their PCC about weight loss and intentions to engage in weight loss. In addition, the study team collect and analyze clinician-reported and patient-reported data to identify factors that may impede or facilitate broad dissemination of this intervention strategy to other care delivery settings.
This innovative project will (a) provide state-of-the-art scientific evidence on obesity treatment to large numbers of obese American adults with T2DM and their PCCs at the point of care; (b) help PCCs identify appropriate patient-specific obesity treatment options; (c) implement in primary care a web-based electronic health record (EHR)-linked obesity treatment clinical decision support model that uses state-of-the-art Health Information Technology (HIT) standards, is broadly scalable, easy to update as evidence changes, and optimized for clear communication of information to patients and PCCs; and (d) improve the clinical return on ongoing massive private and public investments in outpatient health information systems.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- BMI-CDS
- Keywords
- Clinical Decision Support, Shared Decision Making, Diabetes, Metabolic Bariatric Surgery, Obesity Management, Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMI-CDSBehavioural
Also called Weight Loss Wizard, BMI Wizard
The BMI-CDS is a sophisticated point of care shared decision support tool for patients with type 2 diabetes and high BMI. The intervention is built on existing point of care clinical decision support system that algorithmically identifies study-eligible patients and deploys patient-specific CDS output at an index visit and updated CDS all subsequent primary care office, video, and phone encounters.
| Study group | Role | What they receive |
|---|---|---|
| BMI-CDS | Experimental | Clinicians and their patients assigned to intervention clinics will receive shared decision support tools for weight loss management. Receives: Behavioral: BMI-CDS |
| Usual Care | No intervention | Clinicians and their patients assigned to control clinics will engage in the usual standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients referred to an MBS program
Proportion of study-eligible patients with estimated high benefit from MBS seen in clinics with the BMI-CDS intervention will be more likely than patients seen in usual care clinics to receive a referral to MBS
Measured: Within 18 months of index visit date
Number of new prescriptions of an FDA-approved pharmaceutical for obesity management
Patients seen in clinics with the BMI-CDS intervention will be more likely than patients seen in usual care clinics to receive to receive a new prescription medication for obesity management
Measured: Within 18 months of index visit date
Change in weight trajectory during 18-month post-intervention follow-up period
The within-patient slope of weight measurements over the 18 months following the index visit will be less positive for those seen in BMI-CDS intervention versus usual care clinics.
Measured: 18 months following the index visit
Secondary outcomes (2)
Likelihood of patient conversation with their pcc about weight loss
Relative to patients with an index clinical encounter at usual care clinics, those with an index clinical encounter at BMI-CDS clinics will be more likely have had a conversation with their PCC about weight loss.
Measured: 6 months following index visit
Intentions to engage in weight loss
Relative to patients with an index visit at usual care clinics, those with an index clinical encounter at BMI-CDS clinics will report stronger intentions to engage in weight loss.
Measured: 6 months following index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start19 Apr 2023
- Primary completion31 Oct 2025
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick J O'Connor, MD MPH MA, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198765
- Sponsor's protocol ID
- 20-107
- Other IDs
- 1R01DK128281-01
- Acronym
- WL-CDS
- Status last verified
- Sep 2026
- First submitted
- 20 Dec 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Clinical Inertia in Obesity Management of Diabetes Patients in Primary Care: Cluster-Randomized Trial
- ClinicalTrials.gov ID
- NCT05198765
- Acronym / sponsor ID
- WL-CDS / 20-107
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Keywords
- Clinical Decision Support, Shared Decision Making, Diabetes, Metabolic Bariatric Surgery, Obesity Management, Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,120 participants (estimated)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity has been steadily increasing in prevalence and now affects more than 4 in 10 U.S. adults, leading to many adverse health outcomes including myocardial infarction, stroke, type 2 diabetes (T2DM), hypertension, sleep apnea, arthritis, and others. Effective surgical, pharmaceutical, and behavioral treatments for obesity are available, and the evidence to support the broad use of these treatments for obesity is very well established. However, active management of obesity defined as prescribing or referring adults with obesity for lifestyle, pharmaceutical, or surgical treatment of obesity, is greatly underused. Major underlying reasons for underutilization of effective obesity treatments include: (a) both patients and primary care clinicians (PCCs) frequently underestimate the effectiveness and potential benefits of obesity treatments; and (b) both patients and clinicians typically lack access to evidence-based, patient-specific estimates of the potential benefits and risks of appropriate patient-specific obesity treatment options.
To address this problem, the study team will integrate externally validated prediction equations that estimate benefits and risk of various obesity treatment options in adults with T2DM into a widely-used and successful clinical decision support system in order to deliver appropriate patient-specific obesity treatment suggestions at the point of care. The team will implement a scalable, web-based point-of-care decision-support intervention in a randomized trial in 40 primary care clinics with 15,810 eligible patients, and assess intervention impact on the following primary outcomes: (a) appropriate referral of eligible patients for evaluation for metabolic bariatric surgery (MBS); (b) appropriate initiation of FDA-approved medications for weight loss; (c) weight trajectories; and (d) patient-reported conversations with their PCC about weight loss and intentions to engage in weight loss. In addition, the study team collect and analyze clinician-reported and patient-reported data to identify factors that may impede or facilitate broad dissemination of this intervention strategy to other care delivery settings.
This innovative project will (a) provide state-of-the-art scientific evidence on obesity treatment to large numbers of obese American adults with T2DM and their PCCs at the point of care; (b) help PCCs identify appropriate patient-specific obesity treatment options; (c) implement in primary care a web-based electronic health record (EHR)-linked obesity treatment clinical decision support model that uses state-of-the-art Health Information Technology (HIT) standards, is broadly scalable, easy to update as evidence changes, and optimized for clear communication of information to patients and PCCs; and (d) improve the clinical return on ongoing massive private and public investments in outpatient health information systems.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI-CDS | Experimental | Behavioral: BMI-CDSClinicians and their patients assigned to intervention clinics will receive shared decision support tools for weight loss management. |
| Usual Care | No intervention | –Clinicians and their patients assigned to control clinics will engage in the usual standard of care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (age 18-75 years at index clinical encounter)
- Existing diagnosis of T2DM
- BMI ≥35 kg/m2 at index clinical encounter
- 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
Key exclusion criteria (4 listed)
- Prior MBS
- Patients diagnosed with cancer (except non-melanoma skin cancer), dementia, and/or cirrhosis.
- Pregnant or breastfeeding.
- In long-term care, palliative care, or hospice care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMI-CDSAlso: Weight Loss Wizard, BMI WizardThe BMI-CDS is a sophisticated point of care shared decision support tool for patients with type 2 diabetes and high BMI. The intervention is built on existing point of care clinical decision support system that algorithmically identifies study-eligible patients and deploys patient-specific CDS output at an index visit and updated CDS all subsequent primary care office, video, and phone encounters. | Behavioural | BMI-CDS |
Primary outcome
Proportion of patients referred to an MBS program
Time frame: Within 18 months of index visit date
Proportion of study-eligible patients with estimated high benefit from MBS seen in clinics with the BMI-CDS intervention will be more likely than patients seen in usual care clinics to receive a referral to MBS
Number of new prescriptions of an FDA-approved pharmaceutical for obesity management
Time frame: Within 18 months of index visit date
Patients seen in clinics with the BMI-CDS intervention will be more likely than patients seen in usual care clinics to receive to receive a new prescription medication for obesity management
Change in weight trajectory during 18-month post-intervention follow-up period
Time frame: 18 months following the index visit
The within-patient slope of weight measurements over the 18 months following the index visit will be less positive for those seen in BMI-CDS intervention versus usual care clinics.
2 secondary outcomes
Likelihood of patient conversation with their pcc about weight loss
Time frame: 6 months following index visit
Intentions to engage in weight loss
Time frame: 6 months following index visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J O'Connor, MD MPH MA principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMI-CDS in people with Diabetes Mellitus, Type 2 and Obesity, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients referred to an MBS program (time frame: Within 18 months of index visit date). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.