NCT04678752

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100,000

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

64 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

May 30, 2025

Status Verified

April 1, 2025

Enrollment Period

4.5 years

First QC Date

November 24, 2020

Last Update Submit

May 23, 2025

Conditions

Keywords

ObesityPrimary CareElectronic Health Record

Outcome Measures

Primary Outcomes (2)

  • 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 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

    6 to 18 months

Other Outcomes (8)

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

    Baseline and each 1 year step after

  • Qualitative assessment of the reach of patient recruitment

    6 months post intervention start

  • Adoption - The representativeness of providers who initiate the intervention

    Baseline and at each 1 year step

  • +5 more other outcomes

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Each primary care provider will administer weight loss care per their standard practice.

Other: Control

PATHWEIGH

EXPERIMENTAL

A weight management care path that support primary care both through the EHR and training for the clinicians.

Other: Weight management care path

Interventions

* 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

PATHWEIGH
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.

Standard of Care

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Affiliated with a participating primary care practice
  • Provide care for adult patients (\>=18 years old)
  • All adult patients (age \>18 years)
  • BMI \>25 kg/m2
  • Appointment at a primary care clinic participating in the study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (64)

UCHealth Primary Care - Arvada West

Arvada, Colorado, 80007, United States

Location

UCHealth Primary Care - Quincy

Aurora, Colorado, 80015, United States

Location

UCHealth Executive Health Services - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

UCHealth Internal Medicine - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

UCHealth Seniors Clinic - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

UCHealth Women's Integrated Services in Health - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

UCHealth Family Medicine - Boulder

Boulder, Colorado, 80303, United States

Location

UCHealth CU Family Medicine - Depot Hill

Broomfield, Colorado, 80020, United States

Location

UCHealth Primary Care - Broomfield

Broomfield, Colorado, 80020, United States

Location

UCHealth Primary Care - Castle Rock

Castle Rock, Colorado, 80104, United States

Location

UCHealth CU Family Medicine - Centennial

Centennial, Colorado, 80122, United States

Location

UCHealth Primary Care and Sports Medicine Clinic - Lake Plaza

Colorado Springs, Colorado, 80906, United States

Location

UCHealth Primary Care - Fontanero

Colorado Springs, Colorado, 80907, United States

Location

UCHealth Internal Medicine - Printers Park

Colorado Springs, Colorado, 80910, United States

Location

UCHealth Sports Medicine Clinic - Printers Park

Colorado Springs, Colorado, 80910, United States

Location

UCHealth Primary Care - Academy

Colorado Springs, Colorado, 80918, United States

Location

UCHealth Primary Care - Rockrimmon

Colorado Springs, Colorado, 80919, United States

Location

UCHealth Aspen Creek Medical Center

Colorado Springs, Colorado, 80920, United States

Location

UCHealth Primary Care - Briargate

Colorado Springs, Colorado, 80920, United States

Location

UCHealth Primary Care - Chapel Hills

Colorado Springs, Colorado, 80920, United States

Location

UCHealth Primary Care - Scarborough

Colorado Springs, Colorado, 80920, United States

Location

UCHealth Primary Care - Craig

Craig, Colorado, 81625, United States

Location

UCHealth Primary Care - Cripple Creek

Cripple Creek, Colorado, 80813, United States

Location

UCHealth Primary Care - Steele Street

Denver, Colorado, 80206, United States

Location

UCHealth CU Internal Medicine - Garfield

Denver, Colorado, 80209, United States

Location

UCHealth Primary Care - Uptown

Denver, Colorado, 80218, United States

Location

UCHealth Internal Medicine - Lowry

Denver, Colorado, 80230, United States

Location

UCHealth A.F. Williams Family Medicine Clinic - Central Park

Denver, Colorado, 80238, United States

Location

UCHealth Primary Care - Estes Park

Estes Park, Colorado, 80517, United States

Location

UCHealth Primary Care - Falcon

Falcon, Colorado, 80831, United States

Location

UCHealth Family Medicine - Firestone

Firestone, Colorado, 80504, United States

Location

UCHealth Family Medicine Center - Fort Collins

Fort Collins, Colorado, 80524, United States

Location

UCHealth Internal Medicine - Prospect

Fort Collins, Colorado, 80525, United States

Location

UCHealth Internal Medicine - Snow Mesa

Fort Collins, Colorado, 80528, United States

Location

UCHealth Internal Medicine and Pediatric Care Clinic - Snow Mesa

Fort Collins, Colorado, 80528, United States

Location

UCHealth Internal Medicine - Greeley Midtown

Greeley, Colorado, 80538, United States

Location

UCHealth Family Medicine - Greeley

Greeley, Colorado, 80634, United States

Location

UCHealth Internal Medicine - Greeley

Greeley, Colorado, 80634, United States

Location

UCHealth CU Family Medicine - Landmark

Greenwood Village, Colorado, 80111, United States

Location

UCHealth Primary Care - Greenwood Village

Greenwood Village, Colorado, 80111, United States

Location

UCHealth Primary Care - Highlands Ranch

Highlands Ranch, Colorado, 80126, United States

Location

UCHealth Family Medicine - Littleton

Highlands Ranch, Colorado, 80129, United States

Location

UCHealth Primary Care - Sterling Ranch

Littleton, Colorado, 80125, United States

Location

UCHealth Primary Care - Lone Tree

Lone Tree, Colorado, 80124, United States

Location

UCHealth Primary Care - Yosemite

Lone Tree, Colorado, 80124, United States

Location

UCHealth Women's Integrated Services in Health - Lone Tree

Lone Tree, Colorado, 80124, United States

Location

UCHealth Family Medicine - Longmont

Longmont, Colorado, 80501, United States

Location

UCHealth Internal Medicine - Longmont

Longmont, Colorado, 80501, United States

Location

UCHealth Longmont Clinic

Longmont, Colorado, 80501, United States

Location

UCHealth Orchards Medical Center

Loveland, Colorado, 80537, United States

Location

UCHealth Family Medicine - North Loveland

Loveland, Colorado, 80538, United States

Location

UCHealth Internal Medicine - East Loveland

Loveland, Colorado, 80538, United States

Location

UCHealth Internal Medicine - Orchards

Loveland, Colorado, 80538, United States

Location

UCHealth Primary Care - Monument

Monument, Colorado, 80132, United States

Location

UCHealth Primary Care - Hilltop

Parker, Colorado, 80134, United States

Location

UCHealth Primary Care and Women's Wellness - Stonegate

Parker, Colorado, 80134, United States

Location

UCHealth Primary Care - Sterling

Sterling, Colorado, 80751, United States

Location

UCHealth Primary Care - Timnath

Timnath, Colorado, 80547, United States

Location

UCHealth Family Medicine - Westminster

Westminster, Colorado, 80021, United States

Location

UCHealth Family Medicine - Windsor

Windsor, Colorado, 80550, United States

Location

UCHealth Family Medicine - Woodland Park

Woodland Park, Colorado, 80863, United States

Location

Little Snake River Clinic - Managed by UCHealth Yampa Valley Medical Center

Baggs, Wyoming, 82321, United States

Location

UCHealth Cheyenne Medical Specialists

Cheyenne, Wyoming, 82009, United States

Location

UCHealth Primary Care - Cheyenne

Cheyenne, Wyoming, 82009, United States

Location

Related Publications (3)

  • 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. 2025 Dec 11. doi: 10.1038/s41591-025-04051-5. Online ahead of print.

  • 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.

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leigh Perreault, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR
  • Jodi S Holtrop, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Effectiveness-Implementation Hybrid Type 1 Study using a Stepped Wedge Cluster Randomized Trial design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 22, 2020

Study Start

March 17, 2020

Primary Completion

September 16, 2024

Study Completion

July 31, 2025

Last Updated

May 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP

Locations