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PATHWEIGH: Pragmatic Weight M...

PATHWEIGH: Pragmatic Weight Management in Primary Care

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

Total Enrollment

100000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-17

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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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 .

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Effectiveness-Implementation Hybrid Type 1 Study using a Stepped Wedge Cluster Randomized Trial design

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard of Care

Each primary care provider will administer weight loss care per their standard practice.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

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.

PATHWEIGH

A weight management care path that support primary care both through the EHR and training for the clinicians.

Group Type EXPERIMENTAL

Weight management care path

Intervention Type OTHER

* 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

Interventions

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Weight management care path

Intervention Type OTHER

Control

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Affiliated with a participating primary care practice
* Provide care for adult patients (\>=18 years old)

* All adult patients (age \>18 years)
* BMI \>25 kg/m2
* Appointment at a primary care clinic participating in the study

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leigh Perreault, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Jodi S Holtrop, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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UCHealth Primary Care - Arvada West

Arvada, Colorado, United States

Site Status

UCHealth Primary Care - Quincy

Aurora, Colorado, United States

Site Status

UCHealth Executive Health Services - Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

UCHealth Internal Medicine - Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

UCHealth Seniors Clinic - Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

UCHealth Women's Integrated Services in Health - Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

UCHealth Family Medicine - Boulder

Boulder, Colorado, United States

Site Status

UCHealth CU Family Medicine - Depot Hill

Broomfield, Colorado, United States

Site Status

UCHealth Primary Care - Broomfield

Broomfield, Colorado, United States

Site Status

UCHealth Primary Care - Castle Rock

Castle Rock, Colorado, United States

Site Status