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| ID | Type | Description | Link |
|---|---|---|---|
| 1R18DK127003 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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 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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Each primary care provider will administer weight loss care per their standard practice. |
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| PATHWEIGH | Experimental | A weight management care path that support primary care both through the EHR and training for the clinicians. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight management care path | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reach - The representativeness of individuals who participate in the trial. | Individual participants enrolled on the trial versus the number of patients eligible for the trial will be assessed within the electronic medical record. | Baseline and each 1 year step after |
| Qualitative assessment of the reach of patient recruitment |
Clinician Inclusion Criteria:
Patient Inclusion Criteria:
Patient Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leigh Perreault, MD | University of Colorado, Denver | Principal Investigator |
| Jodi S Holtrop, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCHealth Primary Care - Arvada West | Arvada | Colorado | 80007 | United States | ||
| UCHealth Primary Care - Quincy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41927969 | Derived | 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. | |
| 41381746 | Derived | 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. 2026 Feb;32(2):645-652. doi: 10.1038/s41591-025-04051-5. Epub 2025 Dec 11. |
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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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 21, 2026 | |
| Unrelease | Jan 28, 2026 | |
| Release | Jan 28, 2026 |
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Effectiveness-Implementation Hybrid Type 1 Study using a Stepped Wedge Cluster Randomized Trial design
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| 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. |
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| 6 to 18 months |
Interviews with a purposefully selected sample of patients to measure factors that impact patient recruitment to the study. |
| 6 months post intervention start |
| Adoption - The representativeness of providers who initiate the intervention | 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. | Baseline and at each 1 year step |
| Qualitative assessment of adoption of the intervention by medical providers. | Qualitative interviews of a purposefully selected sample of providers will be conducted to understand reasons and barriers to adoption of PATHWEIGH. | 1 year post intervention start/cohort |
| 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 | The number of medical providers who provided the PATHWEIGH intervention to patients correctly (meeting fidelity criteria) which will be abstracted from the medical record. | Every 6 months for 5 years |
| 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 | Interviews with a purposefully selected sample of providers will be conducted to measure factors that impact the implementation of PATHWEIGH. | 6 months post intervention for each cohort through study end |
| Maintenance - The proportion of patients that maintained weight loss at 18 months post enrollment. | Patients will be weighed and the difference from initial weight-prioritized visit. | 18 months post enrollment |
| Maintenance - The extent to which the intervention becomes part of practice | 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. | 1 year post intervention start cohort up till year 5 of the study |
| Aurora |
| Colorado |
| 80015 |
| United States |
| UCHealth Executive Health Services - Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| UCHealth Internal Medicine - Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| UCHealth Seniors Clinic - Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| UCHealth Women's Integrated Services in Health - Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| UCHealth Family Medicine - Boulder | Boulder | Colorado | 80303 | United States |
| UCHealth CU Family Medicine - Depot Hill | Broomfield | Colorado | 80020 | United States |
| UCHealth Primary Care - Broomfield | Broomfield | Colorado | 80020 | United States |
| UCHealth Primary Care - Castle Rock | Castle Rock | Colorado | 80104 | United States |
| UCHealth CU Family Medicine - Centennial | Centennial | Colorado | 80122 | United States |
| UCHealth Primary Care and Sports Medicine Clinic - Lake Plaza | Colorado Springs | Colorado | 80906 | United States |
| UCHealth Primary Care - Fontanero | Colorado Springs | Colorado | 80907 | United States |
| UCHealth Internal Medicine - Printers Park | Colorado Springs | Colorado | 80910 | United States |
| UCHealth Sports Medicine Clinic - Printers Park | Colorado Springs | Colorado | 80910 | United States |
| UCHealth Primary Care - Academy | Colorado Springs | Colorado | 80918 | United States |
| UCHealth Primary Care - Rockrimmon | Colorado Springs | Colorado | 80919 | United States |
| UCHealth Aspen Creek Medical Center | Colorado Springs | Colorado | 80920 | United States |
| UCHealth Primary Care - Briargate | Colorado Springs | Colorado | 80920 | United States |
| UCHealth Primary Care - Chapel Hills | Colorado Springs | Colorado | 80920 | United States |
| UCHealth Primary Care - Scarborough | Colorado Springs | Colorado | 80920 | United States |
| UCHealth Primary Care - Craig | Craig | Colorado | 81625 | United States |
| UCHealth Primary Care - Cripple Creek | Cripple Creek | Colorado | 80813 | United States |
| UCHealth Primary Care - Steele Street | Denver | Colorado | 80206 | United States |
| UCHealth CU Internal Medicine - Garfield | Denver | Colorado | 80209 | United States |
| UCHealth Primary Care - Uptown | Denver | Colorado | 80218 | United States |
| UCHealth Internal Medicine - Lowry | Denver | Colorado | 80230 | United States |
| UCHealth A.F. Williams Family Medicine Clinic - Central Park | Denver | Colorado | 80238 | United States |
| UCHealth Primary Care - Estes Park | Estes Park | Colorado | 80517 | United States |
| UCHealth Primary Care - Falcon | Falcon | Colorado | 80831 | United States |
| UCHealth Family Medicine - Firestone | Firestone | Colorado | 80504 | United States |
| UCHealth Family Medicine Center - Fort Collins | Fort Collins | Colorado | 80524 | United States |
| UCHealth Internal Medicine - Prospect | Fort Collins | Colorado | 80525 | United States |
| UCHealth Internal Medicine - Snow Mesa | Fort Collins | Colorado | 80528 | United States |
| UCHealth Internal Medicine and Pediatric Care Clinic - Snow Mesa | Fort Collins | Colorado | 80528 | United States |
| UCHealth Internal Medicine - Greeley Midtown | Greeley | Colorado | 80538 | United States |
| UCHealth Family Medicine - Greeley | Greeley | Colorado | 80634 | United States |
| UCHealth Internal Medicine - Greeley | Greeley | Colorado | 80634 | United States |
| UCHealth CU Family Medicine - Landmark | Greenwood Village | Colorado | 80111 | United States |
| UCHealth Primary Care - Greenwood Village | Greenwood Village | Colorado | 80111 | United States |
| UCHealth Primary Care - Highlands Ranch | Highlands Ranch | Colorado | 80126 | United States |
| UCHealth Family Medicine - Littleton | Highlands Ranch | Colorado | 80129 | United States |
| UCHealth Primary Care - Sterling Ranch | Littleton | Colorado | 80125 | United States |
| UCHealth Primary Care - Lone Tree | Lone Tree | Colorado | 80124 | United States |
| UCHealth Primary Care - Yosemite | Lone Tree | Colorado | 80124 | United States |
| UCHealth Women's Integrated Services in Health - Lone Tree | Lone Tree | Colorado | 80124 | United States |
| UCHealth Family Medicine - Longmont | Longmont | Colorado | 80501 | United States |
| UCHealth Internal Medicine - Longmont | Longmont | Colorado | 80501 | United States |
| UCHealth Longmont Clinic | Longmont | Colorado | 80501 | United States |
| UCHealth Orchards Medical Center | Loveland | Colorado | 80537 | United States |
| UCHealth Family Medicine - North Loveland | Loveland | Colorado | 80538 | United States |
| UCHealth Internal Medicine - East Loveland | Loveland | Colorado | 80538 | United States |
| UCHealth Internal Medicine - Orchards | Loveland | Colorado | 80538 | United States |
| UCHealth Primary Care - Monument | Monument | Colorado | 80132 | United States |
| UCHealth Primary Care - Hilltop | Parker | Colorado | 80134 | United States |
| UCHealth Primary Care and Women's Wellness - Stonegate | Parker | Colorado | 80134 | United States |
| UCHealth Primary Care - Sterling | Sterling | Colorado | 80751 | United States |
| UCHealth Primary Care - Timnath | Timnath | Colorado | 80547 | United States |
| UCHealth Family Medicine - Westminster | Westminster | Colorado | 80021 | United States |
| UCHealth Family Medicine - Windsor | Windsor | Colorado | 80550 | United States |
| UCHealth Family Medicine - Woodland Park | Woodland Park | Colorado | 80863 | United States |
| Little Snake River Clinic - Managed by UCHealth Yampa Valley Medical Center | Baggs | Wyoming | 82321 | United States |
| UCHealth Cheyenne Medical Specialists | Cheyenne | Wyoming | 82009 | United States |
| UCHealth Primary Care - Cheyenne | Cheyenne | Wyoming | 82009 | United States |
| 37217322 | Derived | 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. |
| 35012628 | Derived | 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. |
| Reset | Feb 16, 2026 |
| Release | May 19, 2026 |
| Reset | Jun 15, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 21, 2026 | Jan 28, 2026 | |||
| Jan 28, 2026 | Feb 16, 2026 | |||
| May 19, 2026 | Jun 15, 2026 | |||
| Jun 17, 2026 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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