PATHWEIGH: Pragmatic Weight Management in Primary Care

Obesity Clinical Trial

Official title:

PATHWEIGH: Pragmatic Weight Management in Primary Care

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04678752
• Other study ID #: 20-1954
• Secondary ID: 1R18DK127003
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 17, 2020
• Est. completion date: September 17, 2025

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study examines patient weight loss and maintenance, associated predictors (patient health characteristics and demographics), and contextual factors in the practice environment that influence the intervention's adoption, implementation, and sustainability. This will be achieved through a mixed methods implementation study including collection and analysis of de-identified clinical data, surveys, observations, and interviews.

Description:

This study will investigate how PATHWEIGH, a weight management tool built into the EPIC electronic health record, in combination with clinician and staff training on the use of PATHWEIGH as a tool, education on effective weight management practices, and practice facilitation to support implementation can facilitate weight loss and maintenance for primary care patients. The study examines patient weight loss and maintenance, associated predictors (patient health characteristics and demographics), and contextual factors in the practice environment that influence the intervention's adoption, implementation, and sustainability. This will be achieved through a mixed methods implementation study including collection and analysis of de-identified clinical data, surveys, observations, and interviews.

This study is being conducted because despite obesity being the leading cause of preventable death in the U.S. and a major risk factor for disease, people with any degree of overweight or obesity are rarely offered anything other than lifestyle advice, rather than more rigorous and evidence-based weight management strategies. Poor reimbursement for weight-related visits, competing priorities, lack of appropriate tools, and limited time in visits also prevent more widespread use of weight management interventions. PATHWEIGH helps primary care clinicians and teams prioritize weight management with their patients when appropriate and ensures that they have the tools and knowledge handy to do so effectively. As part of the assessment of the PATHWEIGH intervention, the study will identify predictors of patient weight loss and weight loss maintenance using mediator and moderator analysis. Relevant factors (patient demographics, health metrics (e.g. vital signs, anthropometrics, comorbidities), behaviors and goals, provider age, sex, years and % time practicing, and clinic information (e.g. size, location, culture scale)) will be evaluated by including interaction terms between the treatment variable and possible moderating variables in outcome regression models .

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100000
• Est. completion date: September 17, 2025
• Est. primary completion date: March 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Clinician Inclusion Criteria:

• Affiliated with a participating primary care practice

• Provide care for adult patients (>=18 years old)

Patient Inclusion Criteria:

• All adult patients (age >18 years)

• BMI >25 kg/m2

• Appointment at a primary care clinic participating in the study

Patient Exclusion Criteria:

• Unable to participate in weight loss treatment due to factors such as cognitive deficits, non-home residence, or limited life expectancy.

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Weight management care path
Documentation and data capture built in the Electronic Health Record Clinical data support that suggests weight loss approach(es) Tracking of weight loss progress and weight loss maintenance during patient visits to guide the patient-clinician conversation Diagnosis and billing in EHR automatically adds the diagnosis of overweight or obesity and links the most common weight-related co-morbidities to ensure adequate provider reimbursement Evidence-based online training on weight management for clinicians Practice quality improvement and training for use of PATHWEIGH for weight-prioritized visits through practice coaches/facilitators Consultation support by practice facilitators with implementing PATHWEIGH and by obesity providers for clinicians with creating patient treatment plans
• Control
Within primary care the option to select "Obesity brief HPI", this is a brief historical intake of a patient's weight - when either they or their clinician decides to have a weight-prioritized visit. It is intended to initiate a discussion regarding potential strategies for weight loss (often "eat less, exercise more"). The provider has the discretion to augment or add support as they see fit.

Locations

Country	Name	City	State
United States	UCHealth Primary Care - Arvada West	Arvada	Colorado
United States	UCHealth Executive Health Services - Anschutz Medical Campus	Aurora	Colorado
United States	UCHealth Internal Medicine - Anschutz Medical Campus	Aurora	Colorado
United States	UCHealth Primary Care - Quincy	Aurora	Colorado
United States	UCHealth Seniors Clinic - Anschutz Medical Campus	Aurora	Colorado
United States	UCHealth Women's Integrated Services in Health - Anschutz Medical Campus	Aurora	Colorado
United States	Little Snake River Clinic - Managed by UCHealth Yampa Valley Medical Center	Baggs	Wyoming
United States	UCHealth Family Medicine - Boulder	Boulder	Colorado
United States	UCHealth CU Family Medicine - Depot Hill	Broomfield	Colorado
United States	UCHealth Primary Care - Broomfield	Broomfield	Colorado
United States	UCHealth Primary Care - Castle Rock	Castle Rock	Colorado
United States	UCHealth CU Family Medicine - Centennial	Centennial	Colorado
United States	UCHealth Cheyenne Medical Specialists	Cheyenne	Wyoming
United States	UCHealth Primary Care - Cheyenne	Cheyenne	Wyoming
United States	UCHealth Aspen Creek Medical Center	Colorado Springs	Colorado
United States	UCHealth Internal Medicine - Printers Park	Colorado Springs	Colorado
United States	UCHealth Primary Care - Academy	Colorado Springs	Colorado
United States	UCHealth Primary Care - Briargate	Colorado Springs	Colorado
United States	UCHealth Primary Care - Chapel Hills	Colorado Springs	Colorado
United States	UCHealth Primary Care - Fontanero	Colorado Springs	Colorado
United States	UCHealth Primary Care - Rockrimmon	Colorado Springs	Colorado
United States	UCHealth Primary Care - Scarborough	Colorado Springs	Colorado
United States	UCHealth Primary Care and Sports Medicine Clinic - Lake Plaza	Colorado Springs	Colorado
United States	UCHealth Sports Medicine Clinic - Printers Park	Colorado Springs	Colorado
United States	UCHealth Primary Care - Craig	Craig	Colorado
United States	UCHealth Primary Care - Cripple Creek	Cripple Creek	Colorado
United States	UCHealth A.F. Williams Family Medicine Clinic - Central Park	Denver	Colorado
United States	UCHealth CU Internal Medicine - Garfield	Denver	Colorado
United States	UCHealth Internal Medicine - Lowry	Denver	Colorado
United States	UCHealth Primary Care - Steele Street	Denver	Colorado
United States	UCHealth Primary Care - Uptown	Denver	Colorado
United States	UCHealth Primary Care - Estes Park	Estes Park	Colorado
United States	UCHealth Primary Care - Falcon	Falcon	Colorado
United States	UCHealth Family Medicine - Firestone	Firestone	Colorado
United States	UCHealth Family Medicine Center - Fort Collins	Fort Collins	Colorado
United States	UCHealth Internal Medicine - Prospect	Fort Collins	Colorado
United States	UCHealth Internal Medicine - Snow Mesa	Fort Collins	Colorado
United States	UCHealth Internal Medicine and Pediatric Care Clinic - Snow Mesa	Fort Collins	Colorado
United States	UCHealth Family Medicine - Greeley	Greeley	Colorado
United States	UCHealth Internal Medicine - Greeley	Greeley	Colorado
United States	UCHealth Internal Medicine - Greeley Midtown	Greeley	Colorado
United States	UCHealth CU Family Medicine - Landmark	Greenwood Village	Colorado
United States	UCHealth Primary Care - Greenwood Village	Greenwood Village	Colorado
United States	UCHealth Family Medicine - Littleton	Highlands Ranch	Colorado
United States	UCHealth Primary Care - Highlands Ranch	Highlands Ranch	Colorado
United States	UCHealth Primary Care - Sterling Ranch	Littleton	Colorado
United States	UCHealth Primary Care - Lone Tree	Lone Tree	Colorado
United States	UCHealth Primary Care - Yosemite	Lone Tree	Colorado
United States	UCHealth Women's Integrated Services in Health - Lone Tree	Lone Tree	Colorado
United States	UCHealth Family Medicine - Longmont	Longmont	Colorado
United States	UCHealth Internal Medicine - Longmont	Longmont	Colorado
United States	UCHealth Longmont Clinic	Longmont	Colorado
United States	UCHealth Family Medicine - North Loveland	Loveland	Colorado
United States	UCHealth Internal Medicine - East Loveland	Loveland	Colorado
United States	UCHealth Internal Medicine - Orchards	Loveland	Colorado
United States	UCHealth Orchards Medical Center	Loveland	Colorado
United States	UCHealth Primary Care - Monument	Monument	Colorado
United States	UCHealth Primary Care - Hilltop	Parker	Colorado
United States	UCHealth Primary Care and Women's Wellness - Stonegate	Parker	Colorado
United States	UCHealth Primary Care - Sterling	Sterling	Colorado
United States	UCHealth Primary Care - Timnath	Timnath	Colorado
United States	UCHealth Family Medicine - Westminster	Westminster	Colorado
United States	UCHealth Family Medicine - Windsor	Windsor	Colorado
United States	UCHealth Family Medicine - Woodland Park	Woodland Park	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reach - The representativeness of individuals who participate in the trial.	Individual participants enrolled on the trial versus the number of patients eligible for the trial will be assessed within the electronic medical record.	Baseline and each 1 year step after
Other	Qualitative assessment of the reach of patient recruitment	Interviews with a purposefully selected sample of patients to measure factors that impact patient recruitment to the study.	6 months post intervention start
Other	Adoption - The representativeness of providers who initiate the intervention	The proportion of medical providers who provide the PATHWEIGH intervention to patients over medical providers who were eligible but chose not to provide the PATHWEIGH intervention will be calculated overall and within each participating clinic.	Baseline and at each 1 year step
Other	Qualitative assessment of adoption of the intervention by medical providers.	Qualitative interviews of a purposefully selected sample of providers will be conducted to understand reasons and barriers to adoption of PATHWEIGH.	1 year post intervention start/cohort
Other	Implementation - The intervention agents' fidelity to the various elements of the intervention's protocol including consistency of delivery as intended and the time and cost of the intervention	The number of medical providers who provided the PATHWEIGH intervention to patients correctly (meeting fidelity criteria) which will be abstracted from the medical record.	Every 6 months for 5 years
Other	Implementation - The intervention agents' fidelity to the various elements of the intervention's protocol including consistency of delivery as intended and the time and cost of the intervention	Interviews with a purposefully selected sample of providers will be conducted to measure factors that impact the implementation of PATHWEIGH.	6 months post intervention for each cohort through study end
Other	Maintenance - The proportion of patients that maintained weight loss at 18 months post enrollment.	Patients will be weighed and the difference from initial weight-prioritized visit.	18 months post enrollment
Other	Maintenance - The extent to which the intervention becomes part of practice	Each practice will be evaluated for the extent to which they continue to use the PATHWEIGH intervention via medical record review indicating intervention use amongst eligible patients.	1 year post intervention start cohort up till year 5 of the study
Primary	Evaluate the implementation of PATHWEIGH and determine its effectiveness versus control clinics using standard of care (SOC) on patient weight loss	Change from baseline	6 months
Secondary	Evaluate the implementation of PATHWEIGH and determine its effectiveness versus standard of care on weight loss maintenance.	To examine weight maintenance we will examine weight change from 6 to 12 months and 6 to 18 months. Weight loss maintenance will be defined as weight increase <10% from the 6-month weight time point.	12 and 18 months