Weight Loss Clinical Decision Support

NCT05198765 | Active Not Recruiting DMC

• 2 other identifiers: 20-1071R01DK128281-01
• Study Type: interventional
• Target: 10,120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Obesity

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  18 months following the index visit

Secondary Outcomes (2)

• Likelihood of patient conversation with their pcc about weight loss

  6 months following index visit

• Intentions to engage in weight loss

  6 months following index visit

Study Arms (2)

BMI-CDS

EXPERIMENTAL

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

Behavioral: BMI-CDS

Usual Care

NO INTERVENTION

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

Interventions

BMI-CDS 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.

Also known as: Weight Loss Wizard, BMI Wizard

BMI-CDS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• HealthPartners Institute: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

HealthPartners Medical Group

Minneapolis, Minnesota, 55440, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick J O'Connor, MD MPH MA

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 20, 2022
• Study Start: April 19, 2023
• Primary Completion: October 31, 2025
• Study Completion: April 30, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)