Weight Loss Clinical Decision Support

NCT ID: NCT05198765

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-19
• Study Completion Date: 2026-04-30

Brief 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 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.

Conditions

Diabetes Mellitus, Type 2; Obesity

Keywords

Clinical Decision Support; Shared Decision Making; Diabetes; Metabolic Bariatric Surgery; Obesity Management; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

BMI-CDS

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

Group Type: EXPERIMENTAL

BMI-CDS

Intervention Type: BEHAVIORAL

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.

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

BMI-CDS

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Weight Loss Wizard; BMI Wizard

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick J O'Connor, MD MPH MA

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Institute

Locations

HealthPartners Medical Group

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1R01DK128281-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-107

Identifier Type: -

Identifier Source: org_study_id