ObesityNCT04678752
PATHWEIGH: Pragmatic Weight Management in Primary Care
A study testing Weight management care path in people with Obesity, run by University of Colorado, Denver at 64 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Obesity
- What is being tested?
- Weight management care path
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100,000 participants
- Where
- 64 sitesUnited States
- Study dates
- 17 Mar 2020to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
64 sites in 1 country. Contact the study team or a site near you to ask about taking part.
64 sites in 1 country
United States64 sites
UCHealth Primary Care - Arvada West
Arvada, Colorado, 80007
UCHealth Primary Care - Quincy
Aurora, Colorado, 80015
UCHealth Executive Health Services - Anschutz Medical Campus
Aurora, Colorado, 80045
UCHealth Internal Medicine - Anschutz Medical Campus
Aurora, Colorado, 80045
UCHealth Seniors Clinic - Anschutz Medical Campus
Aurora, Colorado, 80045
UCHealth Women's Integrated Services in Health - Anschutz Medical Campus
Aurora, Colorado, 80045
Little Snake River Clinic - Managed by UCHealth Yampa Valley Medical Center
Baggs, Wyoming, 82321
UCHealth Family Medicine - Boulder
Boulder, Colorado, 80303
UCHealth CU Family Medicine - Depot Hill
Broomfield, Colorado, 80020
UCHealth Primary Care - Broomfield
Broomfield, Colorado, 80020
UCHealth Primary Care - Castle Rock
Castle Rock, Colorado, 80104
UCHealth CU Family Medicine - Centennial
Centennial, Colorado, 80122
UCHealth Cheyenne Medical Specialists
Cheyenne, Wyoming, 82009
UCHealth Primary Care - Cheyenne
Cheyenne, Wyoming, 82009
UCHealth Primary Care and Sports Medicine Clinic - Lake Plaza
Colorado Springs, Colorado, 80906
UCHealth Primary Care - Fontanero
Colorado Springs, Colorado, 80907
UCHealth Internal Medicine - Printers Park
Colorado Springs, Colorado, 80910
UCHealth Sports Medicine Clinic - Printers Park
Colorado Springs, Colorado, 80910
UCHealth Primary Care - Academy
Colorado Springs, Colorado, 80918
UCHealth Primary Care - Rockrimmon
Colorado Springs, Colorado, 80919
UCHealth Aspen Creek Medical Center
Colorado Springs, Colorado, 80920
UCHealth Primary Care - Briargate
Colorado Springs, Colorado, 80920
UCHealth Primary Care - Chapel Hills
Colorado Springs, Colorado, 80920
UCHealth Primary Care - Scarborough
Colorado Springs, Colorado, 80920
UCHealth Primary Care - Craig
Craig, Colorado, 81625
UCHealth Primary Care - Cripple Creek
Cripple Creek, Colorado, 80813
UCHealth Primary Care - Steele Street
Denver, Colorado, 80206
UCHealth CU Internal Medicine - Garfield
Denver, Colorado, 80209
UCHealth Primary Care - Uptown
Denver, Colorado, 80218
UCHealth Internal Medicine - Lowry
Denver, Colorado, 80230
UCHealth A.F. Williams Family Medicine Clinic - Central Park
Denver, Colorado, 80238
UCHealth Primary Care - Estes Park
Estes Park, Colorado, 80517
UCHealth Primary Care - Falcon
Falcon, Colorado, 80831
UCHealth Family Medicine - Firestone
Firestone, Colorado, 80504
UCHealth Family Medicine Center - Fort Collins
Fort Collins, Colorado, 80524
UCHealth Internal Medicine - Prospect
Fort Collins, Colorado, 80525
UCHealth Internal Medicine - Snow Mesa
Fort Collins, Colorado, 80528
UCHealth Internal Medicine and Pediatric Care Clinic - Snow Mesa
Fort Collins, Colorado, 80528
UCHealth Internal Medicine - Greeley Midtown
Greeley, Colorado, 80538
UCHealth Family Medicine - Greeley
Greeley, Colorado, 80634
UCHealth Internal Medicine - Greeley
Greeley, Colorado, 80634
UCHealth CU Family Medicine - Landmark
Greenwood Village, Colorado, 80111
UCHealth Primary Care - Greenwood Village
Greenwood Village, Colorado, 80111
UCHealth Primary Care - Highlands Ranch
Highlands Ranch, Colorado, 80126
UCHealth Family Medicine - Littleton
Highlands Ranch, Colorado, 80129
UCHealth Primary Care - Sterling Ranch
Littleton, Colorado, 80125
UCHealth Primary Care - Lone Tree
Lone Tree, Colorado, 80124
UCHealth Primary Care - Yosemite
Lone Tree, Colorado, 80124
UCHealth Women's Integrated Services in Health - Lone Tree
Lone Tree, Colorado, 80124
UCHealth Family Medicine - Longmont
Longmont, Colorado, 80501
UCHealth Internal Medicine - Longmont
Longmont, Colorado, 80501
UCHealth Longmont Clinic
Longmont, Colorado, 80501
UCHealth Orchards Medical Center
Loveland, Colorado, 80537
UCHealth Family Medicine - North Loveland
Loveland, Colorado, 80538
UCHealth Internal Medicine - East Loveland
Loveland, Colorado, 80538
UCHealth Internal Medicine - Orchards
Loveland, Colorado, 80538
UCHealth Primary Care - Monument
Monument, Colorado, 80132
UCHealth Primary Care - Hilltop
Parker, Colorado, 80134
UCHealth Primary Care and Women's Wellness - Stonegate
Parker, Colorado, 80134
UCHealth Primary Care - Sterling
Sterling, Colorado, 80751
UCHealth Primary Care - Timnath
Timnath, Colorado, 80547
UCHealth Family Medicine - Westminster
Westminster, Colorado, 80021
UCHealth Family Medicine - Windsor
Windsor, Colorado, 80550
UCHealth Family Medicine - Woodland Park
Woodland Park, Colorado, 80863
About this study
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.
Read the 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 .
- Conditions
- Obesity
- Being tested
- Weight management care path, Control
- Keywords
- Obesity, Primary Care, Electronic Health Record
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight management care pathOther
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Each primary care provider will administer weight loss care per their standard practice. Receives: Other: Control |
| PATHWEIGH | Experimental | A weight management care path that support primary care both through the EHR and training for the clinicians. Receives: Other: Weight management care path |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 6 to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start17 Mar 2020
- Primary completion16 Sep 2024
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Effectiveness-Implementation Hybrid Type 1 Study using a Stepped Wedge Cluster Randomized Trial design
- Masking
- None (open label)
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh Perreault, MD, Principal investigator, University of Colorado, DenverJodi S Holtrop, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678752
- Sponsor's protocol ID
- 20-1954
- Other IDs
- 1R18DK127003
- Status last verified
- Apr 2025
- First submitted
- 24 Nov 2020
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 41927969Perreault 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.
PubMed 41381746Perreault 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.
PubMed 37217322Suresh 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.
PubMed 35012628
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PATHWEIGH: Pragmatic Weight Management in Primary Care
- ClinicalTrials.gov ID
- NCT04678752
- Acronym / sponsor ID
- 20-1954
- Conditions
- Obesity
- Keywords
- Obesity, Primary Care, Electronic Health Record
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Effectiveness-Implementation Hybrid Type 1 Study using a Stepped Wedge Cluster Randomized Trial design
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: ControlEach primary care provider will administer weight loss care per their standard practice. |
| PATHWEIGH | Experimental | Other: Weight management care pathA weight management care path that support primary care both through the EHR and training for the clinicians. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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 | Other | PATHWEIGH |
| ControlWithin 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. | Other | Standard of Care |
Primary outcome
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.
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 41927969Perreault 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.
- Derived from this study: PubMed 41381746Perreault 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.
- Derived from this study: PubMed 37217322Perreault 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.
- Derived from this study: PubMed 35012628Suresh 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leigh Perreault, MD principal investigator
University of Colorado, Denver
Jodi S Holtrop, PhD principal investigator
University of Colorado, Denver
64 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight management care path in people with Obesity, run by University of Colorado, Denver at 64 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04678752, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.