What is the mechanism of action of this treatment?

The PATH program aims to increase physical activity among individuals with obesity by addressing psychological barriers such as stigma, shame, and low exercise self-efficacy, and by promoting enjoyable and less exhausting activities. This approach helps patients engage in regular PA, which improves cardiometabolic outcomes regardless of weight loss. Other common treatments for obesity include dietary changes to reduce caloric intake, pharmacotherapy to suppress appetite or inhibit fat absorption, and behavioral therapy to modify eating and activity habits. These treatments are crucial as they collectively improve physical health, enhance psychological well-being, and reduce the risk of obesity-related diseases.

What side effects are associated with this type of intervention?

Common treatments for obesity that focus on increasing physical activity, such as those in the PATH program, generally have minimal side effects. However, individuals may experience muscle soreness, fatigue, or minor injuries like sprains and strains, especially if they are new to exercise or overexert themselves. Psychological benefits often outweigh these physical discomforts, as enjoyable and stigma-free activities can improve mental health and increase adherence to the program. Other common obesity treatments, such as pharmacotherapy, may have side effects including gastrointestinal issues, headaches, and increased heart rate.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of obesity, including orlistat, phentermine-topiramate, naltrexone-bupropion, and liraglutide. These medications primarily focus on appetite suppression and metabolic enhancement. However, the PATH program takes a different approach by promoting physical activity through reducing psychological barriers such as stigma and low exercise self-efficacy, and by encouraging enjoyable and less exhausting activities. This holistic approach aims to improve overall health and cardiometabolic outcomes, rather than focusing solely on weight loss.

What other types of research exist?

<ol> <li>compuLsive Exercise Activity TheraPy (LEAP): Originally designed for anorexia nervosa, this program could be adapted to address compulsive exercise behaviors and promote balanced physical activity in obesity patients. 2. Home-Based Exercise Interventions: Programs like the HONOR trial, which use wearable technology and telephone coaching, can provide personalized and stigma-free exercise options. 3.</li> </ol> Supervised Exercise Therapy (SET): This involves structured exercise sessions with professional supervision, which can help improve adherence and address psychological barriers. 4. Resistance Training Programs: These focus on muscle strengthening and can be less intimidating and more enjoyable for some patients compared to aerobic exercises. 5. Digital Health Interventions: Apps and online platforms that offer virtual coaching, community support, and personalized exercise plans can be effective in promoting PA among obesity patients.

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Behavioural Intervention

Physical Activity & Education for Obesity

N/A

Waitlist Available

Led By Jacob Kariuki, PhD, NP

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Be older than 18 years old

Must not have

History of cerebrovascular disease (CVD)

History of type 2 diabetes (T2D)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months after screening procedures start

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the PATH program, which offers online exercise routines featuring relatable individuals. It targets people with obesity who face barriers to physical activity. By showing similar people succeeding in exercise, the program aims to motivate participants and improve their health.

Who is the study for?

This trial is for adults over 18 with obesity (BMI ≥30kg/m2) who don't meet physical activity guidelines and have regular internet access. It's not for pregnant individuals, those in health-related litigation, or people needing supervised exercise due to conditions like stroke or diabetes.

What is being tested?

The study tests a program called PATH which uses peers similar in body size and fitness to encourage physical activities like walking, dancing, and toning exercises. Participants will also receive dietary education and use a physical activity tracker.

What are the potential side effects?

Since the interventions involve common physical activities and educational components, side effects are minimal but may include typical exercise-related discomforts such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of stroke or brain blood flow problems.

Select...

I have been diagnosed with type 2 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months after screening procedures start

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months after screening procedures start

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months after screening procedures start for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to protocol procedures

Attainment of recruitment goal

Participants' satisfaction of protocol procedures (acceptability)

+1 more

Secondary study objectives

Changes in Monocyte Chemoattractant Protein-1 (MCP-1)

Changes in T2D risk score

Changes in adiponectin and leptin

+1 more

Other study objectives

Change in exercise self-efficacy questionnaire (EXSE)

Change in exercise self-regulation

Change in the Outcome Expectations for Exercise Scale questionnaires.

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: PATH InterventionExperimental Treatment3 Interventions

Insufficiently active adults with obesity will be assigned to the PATH intervention.

Group II: Control GroupExperimental Treatment3 Interventions

Insufficiently active adults with obesity will be assigned to the attention control group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary education

2015

N/A

~70

PATH Intervention

2021

N/A

~80

Control Group

2012

Completed Phase 2

~2470

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The PATH program aims to increase physical activity among individuals with obesity by addressing psychological barriers such as stigma, shame, and low exercise self-efficacy, and by promoting enjoyable and less exhausting activities. This approach helps patients engage in regular PA, which improves cardiometabolic outcomes regardless of weight loss. Other common treatments for obesity include dietary changes to reduce caloric intake, pharmacotherapy to suppress appetite or inhibit fat absorption, and behavioral therapy to modify eating and activity habits. These treatments are crucial as they collectively improve physical health, enhance psychological well-being, and reduce the risk of obesity-related diseases.