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Clinical Trials/NCT04678752
NCT04678752Enrolling By InvitationNot Applicable

PATHWEIGH: Pragmatic Weight Management in Primary Care

University of Colorado, Denver128 sites in 1 country100,000 target enrollmentStarted: March 17, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
100,000
Locations
128
Primary Endpoint
Patient weight trajectories over the 6 months after the initial weight measured in the usual care and intervention phases

Study Overview

Brief 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.

Detailed 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 .

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 89 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 0 to 6 months

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

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

Time Frame: 6 to 18 months

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

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(6 to 18 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (128)

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