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OpenTrials
Enrolling by Invitation

NCT Number: NCT04678752

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.

Enrolling by Invitation

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCHealth Primary Care - Arvada West, Arvada, Colorado, United States

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About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Weight management care path

Other
  • 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

Control

Other

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 outcomes

  1. 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.

  2. 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

  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

    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.

Other outcomes

  1. Reach - The representativeness of individuals who participate in the trial.

    Time frame: Baseline and each 1 year step after

    Individual participants enrolled on the trial versus the number of patients eligible for the trial will be assessed within the electronic medical record.

  2. Qualitative assessment of the reach of patient recruitment

    Time frame: 6 months post intervention start

    Interviews with a purposefully selected sample of patients to measure factors that impact patient recruitment to the study.

  3. Adoption - The representativeness of providers who initiate the intervention

    Time frame: Baseline and at each 1 year step

    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.

  4. Qualitative assessment of adoption of the intervention by medical providers.

    Time frame: 1 year post intervention start/cohort

    Qualitative interviews of a purposefully selected sample of providers will be conducted to understand reasons and barriers to adoption of PATHWEIGH.

  5. 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

    Time frame: Every 6 months for 5 years

    The number of medical providers who provided the PATHWEIGH intervention to patients correctly (meeting fidelity criteria) which will be abstracted from the medical record.

  6. 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

    Time frame: 6 months post intervention for each cohort through study end

    Interviews with a purposefully selected sample of providers will be conducted to measure factors that impact the implementation of PATHWEIGH.

  7. Maintenance - The proportion of patients that maintained weight loss at 18 months post enrollment.

    Time frame: 18 months post enrollment

    Patients will be weighed and the difference from initial weight-prioritized visit.

  8. Maintenance - The extent to which the intervention becomes part of practice

    Time frame: 1 year post intervention start cohort up till year 5 of the study

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Dec 22, 2020
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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