Clinical trial NCT04678752: PATHWEIGH: Pragmatic Weight Management in Primary Care
Official title: PATHWEIGH: Pragmatic Weight Management in Primary Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obesity
Keywords: Obesity
Primary Care
Electronic Health Record
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-12-22
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Effectiveness-Implementation Hybrid Type 1 Study using a Stepped Wedge Cluster Randomized Trial design
Primary purpose: HEALTH_SERVICES_RESEARCH

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 .

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.

Primary outcomes:
measure: Patient weight trajectories over the 6 months after the initial weight measured in the usual care and intervention phases
timeFrame: 0 to 6 months
measure: 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
timeFrame: 6 to 18 months
Secondary outcomes:
measure: 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
timeFrame: 6 to 18 months
Other outcomes:
measure: Reach - The representativeness of individuals who participate in the trial.
timeFrame: Baseline and each 1 year step after
measure: Qualitative assessment of the reach of patient recruitment
timeFrame: 6 months post intervention start
measure: Adoption - The representativeness of providers who initiate the intervention
timeFrame: Baseline and at each 1 year step
measure: Qualitative assessment of adoption of the intervention by medical providers.
timeFrame: 1 year post intervention start/cohort
measure: 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
timeFrame: Every 6 months for 5 years
measure: 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
timeFrame: 6 months post intervention for each cohort through study end
measure: Maintenance - The proportion of patients that maintained weight loss at 18 months post enrollment.
timeFrame: 18 months post enrollment
measure: Maintenance - The extent to which the intervention becomes part of practice
timeFrame: 1 year post intervention start cohort up till year 5 of the study
Locations:
city: Arvada
country: United States
facility: UCHealth Primary Care - Arvada West
state: Colorado
city: Aurora
country: United States
facility: UCHealth Primary Care - Quincy
state: Colorado
city: Aurora
country: United States
facility: UCHealth Executive Health Services - Anschutz Medical Campus
state: Colorado
city: Aurora
country: United States
facility: UCHealth Internal Medicine - Anschutz Medical Campus
state: Colorado
city: Aurora
country: United States
facility: UCHealth Seniors Clinic - Anschutz Medical Campus
state: Colorado
city: Aurora
country: United States
facility: UCHealth Women's Integrated Services in Health - Anschutz Medical Campus
state: Colorado
city: Boulder
country: United States
facility: UCHealth Family Medicine - Boulder
state: Colorado
city: Broomfield
country: United States
facility: UCHealth CU Family Medicine - Depot Hill
state: Colorado
city: Broomfield
country: United States
facility: UCHealth Primary Care - Broomfield
state: Colorado
city: Castle Rock
country: United States
facility: UCHealth Primary Care - Castle Rock
state: Colorado
city: Centennial
country: United States
facility: UCHealth CU Family Medicine - Centennial
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Primary Care and Sports Medicine Clinic - Lake Plaza
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Primary Care - Fontanero
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Internal Medicine - Printers Park
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Sports Medicine Clinic - Printers Park
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Primary Care - Academy
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Primary Care - Rockrimmon
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Aspen Creek Medical Center
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Primary Care - Briargate
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Primary Care - Chapel Hills
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Primary Care - Scarborough
state: Colorado
city: Craig
country: United States
facility: UCHealth Primary Care - Craig
state: Colorado
city: Cripple Creek
country: United States
facility: UCHealth Primary Care - Cripple Creek
state: Colorado
city: Denver
country: United States
facility: UCHealth Primary Care - Steele Street
state: Colorado
city: Denver
country: United States
facility: UCHealth CU Internal Medicine - Garfield
state: Colorado
city: Denver
country: United States
facility: UCHealth Primary Care - Uptown
state: Colorado
city: Denver
country: United States
facility: UCHealth Internal Medicine - Lowry
state: Colorado
city: Denver
country: United States
facility: UCHealth A.F. Williams Family Medicine Clinic - Central Park
state: Colorado
city: Estes Park
country: United States
facility: UCHealth Primary Care - Estes Park
state: Colorado
city: Falcon
country: United States
facility: UCHealth Primary Care - Falcon
state: Colorado
city: Firestone
country: United States
facility: UCHealth Family Medicine - Firestone
state: Colorado
city: Fort Collins
country: United States
facility: UCHealth Family Medicine Center - Fort Collins
state: Colorado
city: Fort Collins
country: United States
facility: UCHealth Internal Medicine - Prospect
state: Colorado
city: Fort Collins
country: United States
facility: UCHealth Internal Medicine - Snow Mesa
state: Colorado
city: Fort Collins
country: United States
facility: UCHealth Internal Medicine and Pediatric Care Clinic - Snow Mesa
state: Colorado
city: Greeley
country: United States
facility: UCHealth Internal Medicine - Greeley Midtown
state: Colorado
city: Greeley
country: United States
facility: UCHealth Family Medicine - Greeley
state: Colorado
city: Greeley
country: United States
facility: UCHealth Internal Medicine - Greeley
state: Colorado
city: Greenwood Village
country: United States
facility: UCHealth CU Family Medicine - Landmark
state: Colorado
city: Greenwood Village
country: United States
facility: UCHealth Primary Care - Greenwood Village
state: Colorado
city: Highlands Ranch
country: United States
facility: UCHealth Primary Care - Highlands Ranch
state: Colorado
city: Highlands Ranch
country: United States
facility: UCHealth Family Medicine - Littleton
state: Colorado
city: Littleton
country: United States
facility: UCHealth Primary Care - Sterling Ranch
state: Colorado
city: Lone Tree
country: United States
facility: UCHealth Primary Care - Lone Tree
state: Colorado
city: Lone Tree
country: United States
facility: UCHealth Primary Care - Yosemite
state: Colorado
city: Lone Tree
country: United States
facility: UCHealth Women's Integrated Services in Health - Lone Tree
state: Colorado
city: Longmont
country: United States
facility: UCHealth Family Medicine - Longmont
state: Colorado
city: Longmont
country: United States
facility: UCHealth Internal Medicine - Longmont
state: Colorado
city: Longmont
country: United States
facility: UCHealth Longmont Clinic
state: Colorado
city: Loveland
country: United States
facility: UCHealth Orchards Medical Center
state: Colorado
city: Loveland
country: United States
facility: UCHealth Family Medicine - North Loveland
state: Colorado
city: Loveland
country: United States
facility: UCHealth Internal Medicine - East Loveland
state: Colorado
city: Loveland
country: United States
facility: UCHealth Internal Medicine - Orchards
state: Colorado
city: Monument
country: United States
facility: UCHealth Primary Care - Monument
state: Colorado
city: Parker
country: United States
facility: UCHealth Primary Care - Hilltop
state: Colorado
city: Parker
country: United States
facility: UCHealth Primary Care and Women's Wellness - Stonegate
state: Colorado
city: Sterling
country: United States
facility: UCHealth Primary Care - Sterling
state: Colorado
city: Timnath
country: United States
facility: UCHealth Primary Care - Timnath
state: Colorado
city: Westminster
country: United States
facility: UCHealth Family Medicine - Westminster
state: Colorado
city: Windsor
country: United States
facility: UCHealth Family Medicine - Windsor
state: Colorado
city: Woodland Park
country: United States
facility: UCHealth Family Medicine - Woodland Park
state: Colorado
city: Baggs
country: United States
facility: Little Snake River Clinic - Managed by UCHealth Yampa Valley Medical Center
state: Wyoming
city: Cheyenne
country: United States
facility: UCHealth Cheyenne Medical Specialists
state: Wyoming
city: Cheyenne
country: United States
facility: UCHealth Primary Care - Cheyenne
state: Wyoming
Study officials:
affiliation: University of Colorado, Denver
name: Leigh Perreault, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Jodi S Holtrop, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.