Back to resultsPATHWEIGH: Pragmatic Weight Management in Primary Care
Primary Purpose
Obesity
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight management care path
Control
Sponsored by
About this trial
This is an interventional health services research trial for Obesity focused on measuring Obesity, Primary Care, Electronic Health Record
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.
Sites / Locations
- UCHealth Primary Care - Arvada West
- UCHealth Primary Care - Quincy
- UCHealth Executive Health Services - Anschutz Medical Campus
- UCHealth Internal Medicine - Anschutz Medical Campus
- UCHealth Seniors Clinic - Anschutz Medical Campus
- UCHealth Women's Integrated Services in Health - Anschutz Medical Campus
- UCHealth Family Medicine - Boulder
- UCHealth CU Family Medicine - Depot Hill
- UCHealth Primary Care - Broomfield
- UCHealth Primary Care - Castle Rock
- UCHealth CU Family Medicine - Centennial
- UCHealth Primary Care and Sports Medicine Clinic - Lake Plaza
- UCHealth Primary Care - Fontanero
- UCHealth Internal Medicine - Printers Park
- UCHealth Sports Medicine Clinic - Printers Park
- UCHealth Primary Care - Academy
- UCHealth Primary Care - Rockrimmon
- UCHealth Aspen Creek Medical Center
- UCHealth Primary Care - Briargate
- UCHealth Primary Care - Chapel Hills
- UCHealth Primary Care - Scarborough
- UCHealth Primary Care - Craig
- UCHealth Primary Care - Cripple Creek
- UCHealth Primary Care - Steele Street
- UCHealth CU Internal Medicine - Garfield
- UCHealth Primary Care - Uptown
- UCHealth Internal Medicine - Lowry
- UCHealth A.F. Williams Family Medicine Clinic - Central Park
- UCHealth Primary Care - Estes Park
- UCHealth Primary Care - Falcon
- UCHealth Family Medicine - Firestone
- UCHealth Family Medicine Center - Fort Collins
- UCHealth Internal Medicine - Prospect
- UCHealth Internal Medicine - Snow Mesa
- UCHealth Internal Medicine and Pediatric Care Clinic - Snow Mesa
- UCHealth Internal Medicine - Greeley Midtown
- UCHealth Family Medicine - Greeley
- UCHealth Internal Medicine - Greeley
- UCHealth CU Family Medicine - Landmark
- UCHealth Primary Care - Greenwood Village
- UCHealth Primary Care - Highlands Ranch
- UCHealth Family Medicine - Littleton
- UCHealth Primary Care - Sterling Ranch
- UCHealth Primary Care - Lone Tree
- UCHealth Primary Care - Yosemite
- UCHealth Women's Integrated Services in Health - Lone Tree
- UCHealth Family Medicine - Longmont
- UCHealth Internal Medicine - Longmont
- UCHealth Longmont Clinic
- UCHealth Orchards Medical Center
- UCHealth Family Medicine - North Loveland
- UCHealth Internal Medicine - East Loveland
- UCHealth Internal Medicine - Orchards
- UCHealth Primary Care - Monument
- UCHealth Primary Care - Hilltop
- UCHealth Primary Care and Women's Wellness - Stonegate
- UCHealth Primary Care - Sterling
- UCHealth Primary Care - Timnath
- UCHealth Family Medicine - Westminster
- UCHealth Family Medicine - Windsor
- UCHealth Family Medicine - Woodland Park
- Little Snake River Clinic - Managed by UCHealth Yampa Valley Medical Center
- UCHealth Cheyenne Medical Specialists
- UCHealth Primary Care - Cheyenne
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care
PATHWEIGH
Arm Description
Each primary care provider will administer weight loss care per their standard practice.
A weight management care path that support primary care both through the EHR and training for the clinicians.
Outcomes
Primary Outcome Measures
Evaluate the implementation of PATHWEIGH and determine its effectiveness versus control clinics using standard of care (SOC) on patient weight loss
Change from baseline
Secondary Outcome Measures
Evaluate the implementation of PATHWEIGH and determine its effectiveness versus standard of care on weight loss maintenance.
To examine weight maintenance we will examine weight change from 6 to 12 months and 6 to 18 months. Weight loss maintenance will be defined as weight increase <10% from the 6-month weight time point.
Full Information
NCT ID
NCT04678752
First Posted
November 24, 2020
Last Updated
June 14, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT04678752
Brief Title
PATHWEIGH: Pragmatic Weight Management in Primary Care
Official Title
PATHWEIGH: Pragmatic Weight Management in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 17, 2020 (Actual)
Primary Completion Date
March 17, 2025 (Anticipated)
Study Completion Date
September 17, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Primary Care, Electronic Health Record
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Effectiveness-Implementation Hybrid Type 1 Study using a Stepped Wedge Cluster Randomized Trial design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6840 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Each primary care provider will administer weight loss care per their standard practice.
Arm Title
PATHWEIGH
Arm Type
Experimental
Arm Description
A weight management care path that support primary care both through the EHR and training for the clinicians.
Intervention Type
Other
Intervention Name(s)
Weight management care path
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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 Measure Information:
Title
Evaluate the implementation of PATHWEIGH and determine its effectiveness versus control clinics using standard of care (SOC) on patient weight loss
Description
Change from baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Evaluate the implementation of PATHWEIGH and determine its effectiveness versus standard of care on weight loss maintenance.
Description
To examine weight maintenance we will examine weight change from 6 to 12 months and 6 to 18 months. Weight loss maintenance will be defined as weight increase <10% from the 6-month weight time point.
Time Frame
12 and 18 months
Other Pre-specified Outcome Measures:
Title
Reach - The representativeness of individuals who participate in the trial.
Description
Individual participants enrolled on the trial versus the number of patients eligible for the trial will be assessed within the electronic medical record.
Time Frame
Baseline and each 1 year step after
Title
Qualitative assessment of the reach of patient recruitment
Description
Interviews with a purposefully selected sample of patients to measure factors that impact patient recruitment to the study.
Time Frame
6 months post intervention start
Title
Adoption - The representativeness of providers who initiate the intervention
Description
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.
Time Frame
Baseline and at each 1 year step
Title
Qualitative assessment of adoption of the intervention by medical providers.
Description
Qualitative interviews of a purposefully selected sample of providers will be conducted to understand reasons and barriers to adoption of PATHWEIGH.
Time Frame
1 year post intervention start/cohort
Title
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
Description
The number of medical providers who provided the PATHWEIGH intervention to patients correctly (meeting fidelity criteria) which will be abstracted from the medical record.
Time Frame
Every 6 months for 5 years
Title
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
Description
Interviews with a purposefully selected sample of providers will be conducted to measure factors that impact the implementation of PATHWEIGH.
Time Frame
6 months post intervention for each cohort through study end
Title
Maintenance - The proportion of patients that maintained weight loss at 18 months post enrollment.
Description
Patients will be weighed and the difference from initial weight-prioritized visit.
Time Frame
18 months post enrollment
Title
Maintenance - The extent to which the intervention becomes part of practice
Description
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.
Time Frame
1 year post intervention start cohort up till year 5 of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh Perreault, MD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jodi S Holtrop, PhD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCHealth Primary Care - Arvada West
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80007
Country
United States
Facility Name
UCHealth Primary Care - Quincy
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80015
Country
United States
Facility Name
UCHealth Executive Health Services - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
UCHealth Internal Medicine - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
UCHealth Seniors Clinic - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
UCHealth Women's Integrated Services in Health - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
UCHealth Family Medicine - Boulder
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
UCHealth CU Family Medicine - Depot Hill
City
Broomfield
State/Province
Colorado
ZIP/Postal Code
80020
Country
United States
Facility Name
UCHealth Primary Care - Broomfield
City
Broomfield
State/Province
Colorado
ZIP/Postal Code
80020
Country
United States
Facility Name
UCHealth Primary Care - Castle Rock
City
Castle Rock
State/Province
Colorado
ZIP/Postal Code
80104
Country
United States
Facility Name
UCHealth CU Family Medicine - Centennial
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
UCHealth Primary Care and Sports Medicine Clinic - Lake Plaza
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80906
Country
United States
Facility Name
UCHealth Primary Care - Fontanero
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
UCHealth Internal Medicine - Printers Park
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
UCHealth Sports Medicine Clinic - Printers Park
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
UCHealth Primary Care - Academy
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
UCHealth Primary Care - Rockrimmon
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80919
Country
United States
Facility Name
UCHealth Aspen Creek Medical Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
UCHealth Primary Care - Briargate
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
UCHealth Primary Care - Chapel Hills
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
UCHealth Primary Care - Scarborough
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
UCHealth Primary Care - Craig
City
Craig
State/Province
Colorado
ZIP/Postal Code
81625
Country
United States
Facility Name
UCHealth Primary Care - Cripple Creek
City
Cripple Creek
State/Province
Colorado
ZIP/Postal Code
80813
Country
United States
Facility Name
UCHealth Primary Care - Steele Street
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
UCHealth CU Internal Medicine - Garfield
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
UCHealth Primary Care - Uptown
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
UCHealth Internal Medicine - Lowry
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
UCHealth A.F. Williams Family Medicine Clinic - Central Park
City
Denver
State/Province
Colorado
ZIP/Postal Code
80238
Country
United States
Facility Name
UCHealth Primary Care - Estes Park
City
Estes Park
State/Province
Colorado
ZIP/Postal Code
80517
Country
United States
Facility Name
UCHealth Primary Care - Falcon
City
Falcon
State/Province
Colorado
ZIP/Postal Code
80831
Country
United States
Facility Name
UCHealth Family Medicine - Firestone
City
Firestone
State/Province
Colorado
ZIP/Postal Code
80504
Country
United States
Facility Name
UCHealth Family Medicine Center - Fort Collins
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
UCHealth Internal Medicine - Prospect
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80525
Country
United States
Facility Name
UCHealth Internal Medicine - Snow Mesa
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
UCHealth Internal Medicine and Pediatric Care Clinic - Snow Mesa
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
UCHealth Internal Medicine - Greeley Midtown
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
UCHealth Family Medicine - Greeley
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80634
Country
United States
Facility Name
UCHealth Internal Medicine - Greeley
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80634
Country
United States
Facility Name
UCHealth CU Family Medicine - Landmark
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
UCHealth Primary Care - Greenwood Village
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
UCHealth Primary Care - Highlands Ranch
City
Highlands Ranch
State/Province
Colorado
ZIP/Postal Code
80126
Country
United States
Facility Name
UCHealth Family Medicine - Littleton
City
Highlands Ranch
State/Province
Colorado
ZIP/Postal Code
80129
Country
United States
Facility Name
UCHealth Primary Care - Sterling Ranch
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80125
Country
United States
Facility Name
UCHealth Primary Care - Lone Tree
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
UCHealth Primary Care - Yosemite
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
UCHealth Women's Integrated Services in Health - Lone Tree
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
UCHealth Family Medicine - Longmont
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
UCHealth Internal Medicine - Longmont
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
UCHealth Longmont Clinic
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
UCHealth Orchards Medical Center
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80537
Country
United States
Facility Name
UCHealth Family Medicine - North Loveland
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
UCHealth Internal Medicine - East Loveland
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
UCHealth Internal Medicine - Orchards
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
UCHealth Primary Care - Monument
City
Monument
State/Province
Colorado
ZIP/Postal Code
80132
Country
United States
Facility Name
UCHealth Primary Care - Hilltop
City
Parker
State/Province
Colorado
ZIP/Postal Code
80134
Country
United States
Facility Name
UCHealth Primary Care and Women's Wellness - Stonegate
City
Parker
State/Province
Colorado
ZIP/Postal Code
80134
Country
United States
Facility Name
UCHealth Primary Care - Sterling
City
Sterling
State/Province
Colorado
ZIP/Postal Code
80751
Country
United States
Facility Name
UCHealth Primary Care - Timnath
City
Timnath
State/Province
Colorado
ZIP/Postal Code
80547
Country
United States
Facility Name
UCHealth Family Medicine - Westminster
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80021
Country
United States
Facility Name
UCHealth Family Medicine - Windsor
City
Windsor
State/Province
Colorado
ZIP/Postal Code
80550
Country
United States
Facility Name
UCHealth Family Medicine - Woodland Park
City
Woodland Park
State/Province
Colorado
ZIP/Postal Code
80863
Country
United States
Facility Name
Little Snake River Clinic - Managed by UCHealth Yampa Valley Medical Center
City
Baggs
State/Province
Wyoming
ZIP/Postal Code
82321
Country
United States
Facility Name
UCHealth Cheyenne Medical Specialists
City
Cheyenne
State/Province
Wyoming
ZIP/Postal Code
82009
Country
United States
Facility Name
UCHealth Primary Care - Cheyenne
City
Cheyenne
State/Province
Wyoming
ZIP/Postal Code
82009
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35012628
Citation
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.
Results Reference
derived
Learn more about this trial
PATHWEIGH: Pragmatic Weight Management in Primary Care
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