PATHWEIGH: Pragmatic Weight Management in Primary Care

N/AEnrolling By InvitationNCT04678752

University of Colorado, Denver100,000 enrolled

Overview

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 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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

100,000

Conditions

Obesity

Interventions

Weight management care pathOTHER

* 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

ControlOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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.

Locations (64)

Outcomes

Primary Outcomes

Patient weight trajectories over the 6 months after the initial weight measured in the usual care and intervention phases

Change in patient weight trajectories 0-6 months after the initial weight measurement in the usual care and intervention phases.

Time frame: 0 to 6 months

Patient weight maintenance, as measured by patient weight trajectories from 6 to 18 months after the initial weight measurement, in the usual care and intervention phases

Change in patient weight trajectories from 6 to 18 months after the initial weight measurement in the usual care and intervention phases.

Time frame: 6 to 18 months

Secondary Outcomes

Patient weight maintenance, as measured by patient weight trajectories from 6 to 18 months after the initial weight measurement, in the usual care and intervention phases stratified by those received vs. did not receive discernible weight-related care

Change in weight from 6 to 18 months after the initial weight measurement in the usual care and intervention phases stratified by those who did and did not receive discernible weight related care.

Time frame: 6 to 18 months

Data from ClinicalTrials.gov

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