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Compensation: Varies

Number of Visits: Unknown

Weight Management for Obesity

Enrolling by invitation at 63 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Cognitive deficits, Non-home residence, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores various methods to help individuals with obesity lose weight and maintain the loss. It compares standard care provided by doctors to a new weight management care path that offers additional support for both doctors and patients. The trial seeks to determine how personal health factors and the clinic setting influence weight loss success. Suitable candidates for this trial have a BMI over 25 (a measure of body fat based on height and weight) and visit a participating primary care clinic. Participants should be able to engage in a weight loss program without significant barriers, such as severe cognitive issues or living outside a home environment. As an unphased trial, this study provides a unique opportunity to contribute to innovative weight management strategies that could benefit many in the future.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this weight management care path is safe?

Research has shown that the PATHWEIGH weight management program has been tested in regular doctor's offices. It helps doctors apply the latest research to support weight loss. Early results suggest this method is safe for patients, with no reports of serious side effects or problems related to the program itself.

Since PATHWEIGH uses tools already in electronic medical records, it enables doctors to guide patients without adding extra risks. This indicates the program is well-tolerated. While the research doesn't provide detailed safety data, the absence of reported issues in studies is reassuring.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial?

Researchers are excited about the PATHWEIGH weight management care path because it offers a fresh, holistic approach to tackling obesity. Unlike traditional treatments that rely primarily on medication or diet plans, PATHWEIGH integrates support directly into the primary care setting through electronic health records (EHR) and specialized training for clinicians. This approach aims to seamlessly blend weight management into routine healthcare, potentially leading to more personalized and consistent care. By enhancing the tools and knowledge available to healthcare providers, PATHWEIGH could improve patient outcomes and make weight management more sustainable over the long term.

What evidence suggests that this trial's treatments could be effective for weight management?

Research has shown that PATHWEIGH, one of the treatment arms in this trial, may help patients lose weight more effectively. This program uses tools in electronic medical records to guide care and overcome challenges. Studies indicate that PATHWEIGH provides evidence-based support to patients through their primary care teams. Early results suggest that PATHWEIGH could help patients lose weight and maintain it by supporting primary care with electronic health record tools and clinician training. Although more research is needed, the program aims to simplify weight management for doctors and their patients.² ³ ⁵ ⁶ ⁷

Who Is on the Research Team?

Jodi S Holtrop, PhD

Principal Investigator

University of Colorado, Denver

Leigh Perreault, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults over 18 years old with obesity, indicated by a BMI greater than 25 kg/m2. Participants must be receiving care at a primary care clinic involved in the study and affiliated with a participating practice.

Inclusion Criteria

I care for patients who are 18 years old or older.

You are overweight with a Body Mass Index (BMI) over 25 kg/m2.

If you are interested in being a part of our study, please call and schedule an appointment with the clinic coordinator

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the PATHWEIGH weight management tool and training for clinicians

6 months

Regular visits as per primary care schedule

Maintenance

Evaluation of weight maintenance and continued use of PATHWEIGH intervention

12 months

Periodic evaluations

Follow-up

Participants are monitored for weight maintenance and intervention adoption

5 years

What Are the Treatments Tested in This Trial?

Interventions

Control
Weight management care path

Trial Overview The PATHWEIGH study is testing a weight management program against usual care (control) in primary care settings. It looks at how well patients lose and maintain weight, factors affecting outcomes, and how practices adopt the program.

How Is the Trial Designed?

2Treatment groups

Experimental Treatment

Active Control

Group I: PATHWEIGHExperimental Treatment1 Intervention

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

Group II: Standard of CareActive Control1 Intervention

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Interdisciplinary long-term programs involving physicians, psychologists, physiotherapists, and dieticians are essential for effectively treating obesity and improving patient outcomes.

Combination treatments, such as formula diets followed by reduction diets and behavioral therapy with physiotherapy, have shown to be successful in reducing obesity and its associated health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Successful treatment of obesity].Wechsler, JG., Leopold, K., Bischoff, G.[2019]

In a study of 95,251 adults undergoing bariatric surgery, Roux-en-Y gastric bypass (RYGB) had the highest rate of 30-day adverse events (3.8%) compared to adjustable gastric banding (AGB) and sleeve gastrectomy (SG), which had rates of 3.1% and 2.8%, respectively.

RYGB also showed higher hospitalization rates and mortality compared to AGB and SG, indicating that while RYGB may be effective, it carries more immediate and long-term risks than the other procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions and Operations after Bariatric Surgery in a Health Plan Research Network Cohort from the PCORnet, the National Patient-Centered Clinical Research Network.Ma, Q., Shambhu, S., Arterburn, DE., et al.[2021]

Losing just 5% of body weight can lead to significant health improvements, but many individuals struggle to maintain weight loss through diet and exercise alone, highlighting the need for additional treatment options.

As of 2012, two new medications, lorcaserin and phentermine/topiramate, have been approved for long-term obesity treatment, and bariatric surgery is recommended for patients with severe obesity (BMI ≥40 or ≥35 with comorbidities) as a more intensive intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity consults--comprehensive obesity management in 2013: understanding the shifting paradigm.Kushner, RF., Apovian, CM., Fujioka, K.[2018]

Citations

1.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC8744030/

PATHWEIGH, pragmatic weight management in adult ...PATHWEIGH is a pragmatic approach to weight management that uses tools built into the electronic medical record to overcome barriers and guide care.

2.medschool.cuanschutz.edumedschool.cuanschutz.edu/pathweigh/research-on-pathweigh

PATHWEIGH: Pragmatic Weight Management in Primary CarePATHWEIGH is a clinical strategy for weight management intended to help primary care practice teams provide the latest evidence-based help to their own patients ...

3.clinicaltrials.govclinicaltrials.gov/study/NCT04678752?tab=table

PATHWEIGH: Pragmatic Weight Management in Primary ...The study examines patient weight loss and maintenance, associated predictors (patient health characteristics and demographics), and contextual factors in the ...

4.annfammed.organnfammed.org/content/annalsfm/21/3/249.full.pdf

Baseline Characteristics of PATHWEIGHThe eventual aims of this study are to (1) compare the effectiveness of PATHWEIGH vs SOC on patient weight loss and weight-loss maintenance, (2) identify.

5.adameetingnews.orgadameetingnews.org/researchers-to-share-pathweigh-roadmap-for-implementing-weight-management-processes-into-primary-care/

Researchers to share PATHWEIGH 'roadmap' for ...A team of investigators will share their findings from PATHWEIGH, an ongoing study exploring a clinical strategy for weight management.

6.reporter.nih.govreporter.nih.gov/project-details/10912543

PATHWEIGH: pragmatic weight management in primary careOur pilot study demonstrated the ability to effectively implement PATHWEIGH in a primary care clinic that lead to significant improvement in patient weight loss ...

7.trialsjournal.biomedcentral.comtrialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05954-7

PATHWEIGH, pragmatic weight management in adult patients ...PATHWEIGH is a pragmatic approach to weight management that uses tools built into the electronic medical record to overcome barriers and guide care.

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Weight Management for Obesity

What You Need to Know Before You Apply

Who Is on the Research Team?

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Published Research Related to This Trial

Citations

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