PATHWEIGH: Pragmatic Weight Management in Primary Care

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.

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 .

Interventions

• 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 managem
• 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.

Primary outcome measures

• 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]
• 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]

Secondary outcome measures (1)

• 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 [Time frame: 6 to 18 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 64 centers

• UCHealth Primary Care - Arvada West — Arvada
• UCHealth Primary Care - Quincy — Aurora
• UCHealth Executive Health Services - Anschutz Medical Campus — Aurora
• UCHealth Internal Medicine - Anschutz Medical Campus — Aurora
• UCHealth Seniors Clinic - Anschutz Medical Campus — Aurora
• UCHealth Women's Integrated Services in Health - Anschutz Medical Campus — Aurora
• UCHealth Family Medicine - Boulder — Boulder
• UCHealth CU Family Medicine - Depot Hill — Broomfield
• … and 56 more centers

Publications

• Perreault L, Rodriguez C, Smith PC, Kramer ES, Tolle L, Williams J 2nd, Pan Q. Mediators and moderators of successful population-level weight management in primary care: results from the PATHWEIGH cluster-randomized pragmatic trial. Int J Obes (Lond). 2026 Jun;50(6):1369-1372. doi: 10.1038/s41366-026-02072-9. Epub 2026 Apr 2. PMID 41927969
• Perreault L, Pan Q, Rodriguez C, Gritz RM, Smith PC, Kramer ES, Tolle L, Connelly L, Tietbohl C, Williams J 2nd, Holtrop JS. Implementation and effectiveness of a care process to prioritize weight management in primary care: a stepped-wedge cluster-randomized trial. Nat Med. 2026 Feb;32(2):645-652. doi: 10.1038/s41591-025-04051-5. Epub 2025 Dec 11. PMID 41381746
• Perreault L, Suresh K, Rodriguez C, Dickinson LM, Willems E, Smith PC, Williams J Jr, Gritz RM, Holtrop JS. Baseline Characteristics of PATHWEIGH: A Stepped-Wedge Cluster Randomized Study for Weight Management in Primary Care. Ann Fam Med. 2023 May-Jun;21(3):249-255. doi: 10.1370/afm.2966. PMID 37217322
• 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. PMID 35012628

Identifiers

NCT: NCT04678752 · 20-1954 · 1R18DK127003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗