Weight Management for Obesity

Recruiting 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100000 Participants Needed

Trial Summary

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 data supports the effectiveness of the weight management care path treatment for obesity?

Research shows that losing even 5% of body weight can have significant health benefits, and while some people can maintain weight loss with diet and exercise, many need additional support. New medications and comprehensive management strategies, including lifestyle changes and possibly surgery, are being explored to help more people achieve and maintain weight loss. ^{1 2 3 4 5}

Is the weight management treatment safe for humans?

The safety of weight management treatments varies. Some medications like phentermine/topiramate and liraglutide have specific risks such as fetal toxicity and gallstone disease, while others like orlistat and lorcaserin mostly have mild, temporary side effects. Overall, many new anti-obesity medications are considered safe, but long-term safety data is still needed. ^{4 6 7 8 9}

How does the Weight management care path treatment for obesity differ from other treatments?

The Weight management care path is unique because it emphasizes a comprehensive, patient-centered approach that integrates lifestyle changes, such as diet and exercise, with potential pharmacological and surgical options, tailored to individual needs and conditions. This approach is more holistic compared to treatments that focus solely on medication or surgery. ^{10 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Jodi S Holtrop, PhD

Principal Investigator

University of Colorado, Denver

Leigh Perreault, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: PATHWEIGH Experimental Treatment 1 Intervention

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

Group II: Standard of Care Active Control 1 Intervention

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

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+

Findings from Research

A comprehensive review of 497 randomized controlled trials involving nearly 100,000 adults with overweight or obesity highlighted that most self-management interventions focused on clinical outcomes and behavior adherence, but less on empowerment, quality of life, and patient satisfaction.

The most common techniques used in these interventions were information sharing, goal setting, and self-monitoring, often delivered face-to-face, indicating a need for more diverse approaches that include emotional support and remote techniques, especially for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management interventions for adults living with obesity to improve patient-relevant outcomes: An evidence map. Sunol, R., González-González, AI., Valli, C., et al.[2023]

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]

The treatment of obesity aims to prevent complications, achieve realistic weight loss, and ensure psychological well-being, highlighting the need for personalized approaches rather than one-size-fits-all solutions.

Effective management includes a combination of physical exercise, dietary counseling, medication, and sometimes surgery, with psychological support being essential for overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of obesity]. Basdevant, A.[2006]

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]

Modest weight loss of about 5% through dietary changes and increased activity can significantly reduce the risk of obesity-related diseases and delay the onset of type 2 diabetes in patients with a BMI of 27 or higher.

Weight loss medications can enhance adherence to lifestyle changes and lead to meaningful improvements in health outcomes, but careful selection and understanding of the benefits and risks of these medications are essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of weight loss drugs. Wittert, G., Caterson, I., Finer, N.[2014]

New generation anti-obesity medications, such as orlistat, phentermine/topiramate, and liraglutide 3.0 mg, have varying safety profiles, with some presenting significant risks like fetal toxicity and gallstone disease, while others mainly cause transient tolerability issues.

Despite their effectiveness in weight loss, the prescription rates for these medications are low, partly due to safety concerns and the need for more long-term data to better understand their risk-benefit profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of new-generation anti-obesity medications: a narrative review. Patel, DK., Stanford, FC.[2023]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Self-management interventions for adults living with obesity to improve patient-relevant outcomes: An evidence map. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Baseline Characteristics of PATHWEIGH: A Stepped-Wedge Cluster Randomized Study for Weight Management in Primary Care. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Core outcome set for behavioural weight management interventions for adults with overweight and obesity: Standardised reporting of lifestyle weight management interventions to aid evaluation (STAR-LITE). [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Obesity consults--comprehensive obesity management in 2013: understanding the shifting paradigm. [2018]

5. France pubmed.ncbi.nlm.nih.gov

[Treatment of obesity]. [2006]

6. United States 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. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of weight loss drugs. [2014]

8. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of new-generation anti-obesity medications: a narrative review. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of obesity: clinical treatments and considerations. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Weight loss strategies for treatment of obesity. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Treatment of obesity in 2015. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies for Treatment of Obesity: Lifestyle Management and Pharmacotherapy. [2019]

13. Germany pubmed.ncbi.nlm.nih.gov

[Successful treatment of obesity]. [2019]

14. Czech Republic pubmed.ncbi.nlm.nih.gov

Clinical guidelines for diagnosis and management of obesity in the Czech Republic. [2009]