PATHWEIGH: Pragmatic Weight Management in Primary Care

University of Colorado Denver (CU Denver)

Status: Invitation-only

Conditions: Obesity

Treatments: Other: Control; Other: Weight management care path

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04678752

1R18DK127003 (U.S. NIH Grant/Contract)

20-1954

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 100,000 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100,000 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

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

Treatment:

Other: Control

PATHWEIGH

Experimental group

Description:

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

Treatment:

Other: Weight management care path