PATHWEIGH: Pragmatic Weight Management in Primary Care

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity
• Intervention / Treatment: Other: Control; Other: Weight management care path

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 Type: Interventional
• Enrollment (Estimated): 100000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Arvada, Colorado, United States, 80007
      • UCHealth Primary Care - Arvada West
    • Aurora, Colorado, United States, 80015
      • UCHealth Primary Care - Quincy
    • Aurora, Colorado, United States, 80045
      • UCHealth Executive Health Services - Anschutz Medical Campus
    • Aurora, Colorado, United States, 80045
      • UCHealth Internal Medicine - Anschutz Medical Campus
    • Aurora, Colorado, United States, 80045
      • UCHealth Seniors Clinic - Anschutz Medical Campus
    • Aurora, Colorado, United States, 80045
      • UCHealth Women's Integrated Services in Health - Anschutz Medical Campus
    • Boulder, Colorado, United States, 80303
      • UCHealth Family Medicine - Boulder
    • Broomfield, Colorado, United States, 80020
      • UCHealth CU Family Medicine - Depot Hill
    • Broomfield, Colorado, United States, 80020
      • UCHealth Primary Care - Broomfield
    • Castle Rock, Colorado, United States, 80104
      • UCHealth Primary Care - Castle Rock
    • Centennial, Colorado, United States, 80122
      • UCHealth CU Family Medicine - Centennial
    • Colorado Springs, Colorado, United States, 80906
      • UCHealth Primary Care and Sports Medicine Clinic - Lake Plaza
    • Colorado Springs, Colorado, United States, 80907
      • UCHealth Primary Care - Fontanero
    • Colorado Springs, Colorado, United States, 80910
      • UCHealth Internal Medicine - Printers Park
    • Colorado Springs, Colorado, United States, 80910
      • UCHealth Sports Medicine Clinic - Printers Park
    • Colorado Springs, Colorado, United States, 80918
      • UCHealth Primary Care - Academy
    • Colorado Springs, Colorado, United States, 80919
      • UCHealth Primary Care - Rockrimmon
    • Colorado Springs, Colorado, United States, 80920
      • UCHealth Aspen Creek Medical Center
    • Colorado Springs, Colorado, United States, 80920
      • UCHealth Primary Care - Briargate
    • Colorado Springs, Colorado, United States, 80920
      • UCHealth Primary Care - Chapel Hills
    • Colorado Springs, Colorado, United States, 80920
      • UCHealth Primary Care - Scarborough
    • Craig, Colorado, United States, 81625
      • UCHealth Primary Care - Craig
    • Cripple Creek, Colorado, United States, 80813
      • UCHealth Primary Care - Cripple Creek
    • Denver, Colorado, United States, 80206
      • UCHealth Primary Care - Steele Street
    • Denver, Colorado, United States, 80209
      • UCHealth CU Internal Medicine - Garfield
    • Denver, Colorado, United States, 80218
      • UCHealth Primary Care - Uptown
    • Denver, Colorado, United States, 80230
      • UCHealth Internal Medicine - Lowry
    • Denver, Colorado, United States, 80238
      • UCHealth A.F. Williams Family Medicine Clinic - Central Park
    • Estes Park, Colorado, United States, 80517
      • UCHealth Primary Care - Estes Park
    • Falcon, Colorado, United States, 80831
      • UCHealth Primary Care - Falcon
    • Firestone, Colorado, United States, 80504
      • UCHealth Family Medicine - Firestone
    • Fort Collins, Colorado, United States, 80524
      • UCHealth Family Medicine Center - Fort Collins
    • Fort Collins, Colorado, United States, 80525
      • UCHealth Internal Medicine - Prospect
    • Fort Collins, Colorado, United States, 80528
      • UCHealth Internal Medicine - Snow Mesa
    • Fort Collins, Colorado, United States, 80528
      • UCHealth Internal Medicine and Pediatric Care Clinic - Snow Mesa
    • Greeley, Colorado, United States, 80538
      • UCHealth Internal Medicine - Greeley Midtown
    • Greeley, Colorado, United States, 80634
      • UCHealth Family Medicine - Greeley
    • Greeley, Colorado, United States, 80634
      • UCHealth Internal Medicine - Greeley
    • Greenwood Village, Colorado, United States, 80111
      • UCHealth CU Family Medicine - Landmark
    • Greenwood Village, Colorado, United States, 80111
      • UCHealth Primary Care - Greenwood Village
    • Highlands Ranch, Colorado, United States, 80126
      • UCHealth Primary Care - Highlands Ranch
    • Highlands Ranch, Colorado, United States, 80129
      • UCHealth Family Medicine - Littleton
    • Littleton, Colorado, United States, 80125
      • UCHealth Primary Care - Sterling Ranch
    • Lone Tree, Colorado, United States, 80124
      • UCHealth Primary Care - Lone Tree
    • Lone Tree, Colorado, United States, 80124
      • UCHealth Primary Care - Yosemite
    • Lone Tree, Colorado, United States, 80124
      • UCHealth Women's Integrated Services in Health - Lone Tree
    • Longmont, Colorado, United States, 80501
      • UCHealth Family Medicine - Longmont
    • Longmont, Colorado, United States, 80501
      • UCHealth Internal Medicine - Longmont
    • Longmont, Colorado, United States, 80501
      • UCHealth Longmont Clinic
    • Loveland, Colorado, United States, 80537
      • UCHealth Orchards Medical Center
    • Loveland, Colorado, United States, 80538
      • UCHealth Family Medicine - North Loveland
    • Loveland, Colorado, United States, 80538
      • UCHealth Internal Medicine - East Loveland
    • Loveland, Colorado, United States, 80538
      • UCHealth Internal Medicine - Orchards
    • Monument, Colorado, United States, 80132
      • UCHealth Primary Care - Monument
    • Parker, Colorado, United States, 80134
      • UCHealth Primary Care - Hilltop
    • Parker, Colorado, United States, 80134
      • UCHealth Primary Care and Women's Wellness - Stonegate
    • Sterling, Colorado, United States, 80751
      • UCHealth Primary Care - Sterling
    • Timnath, Colorado, United States, 80547
      • UCHealth Primary Care - Timnath
    • Westminster, Colorado, United States, 80021
      • UCHealth Family Medicine - Westminster
    • Windsor, Colorado, United States, 80550
      • UCHealth Family Medicine - Windsor
    • Woodland Park, Colorado, United States, 80863
      • UCHealth Family Medicine - Woodland Park
  • Wyoming
    • Baggs, Wyoming, United States, 82321
      • Little Snake River Clinic - Managed by UCHealth Yampa Valley Medical Center
    • Cheyenne, Wyoming, United States, 82009
      • UCHealth Cheyenne Medical Specialists
    • Cheyenne, Wyoming, United States, 82009
      • UCHealth Primary Care - Cheyenne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Each primary care provider will administer weight loss care per their standard practice.	Other: 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.
Experimental: PATHWEIGH; A weight management care path that support primary care both through the EHR and training for the clinicians.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 to 18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Leigh Perreault, MD, University of Colorado, Denver; Principal Investigator: Jodi S Holtrop, PhD, University of Colorado, Denver

Publications and helpful links

General Publications

• Suresh K, Holtrop JS, Dickinson LM, Willems E, Smith PC, Gritz RM, Perreault L. PATHWEIGH, pragmatic weight management in adult patients in primary care in Colorado, USA: study protocol for a stepped wedge cluster randomized trial. Trials. 2022 Jan 10;23(1):26. doi: 10.1186/s13063-021-05954-7.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2020
• Primary Completion (Actual): September 16, 2024
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Primary Care; Electronic Health Record
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: 20-1954; 1R18DK127003 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing from 1R18DK127003 will comply with policies from the NIH https://grants.nih.gov/grants/policy/data_sharing/), ICMJE (http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html#two), as well as our IRB. No individual participant data will be shared. Data that will be publicly available (through their publication) will include study protocol, analysis plan, and results presented in aggregate. Additional information may be shared upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No