Physical Activity & Education for Obesity

Overseen By Jacob Kariuki, PhD, NP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Pregnancy, CVD, T2D, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how physical activity (PA) can enhance health for people with obesity, without emphasizing weight loss. The researchers aim to understand how enjoyable and accessible exercises can overcome barriers like stigma and poor fitness, benefiting heart health and metabolism. Participants will be divided into two groups: one will follow a new PA program called the PATH Intervention, and the other will serve as a control group. Suitable candidates are adults with a BMI over 30 who currently engage in less than 150 minutes of moderate activity per week.

As an unphased trial, this study provides a unique opportunity to contribute to understanding how physical activity can improve health beyond weight loss.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the PATH intervention is safe for individuals with obesity?

Research has shown that the PATH program effectively helps people with obesity overcome barriers to physical activity. Although specific safety details about this program aren't highlighted in available sources, the PATH program emphasizes physical activity, which is generally safe for most people when performed correctly.

The program is inclusive, offering fun and easily accessible activities to reduce stigma and improve fitness without focusing solely on weight loss. This emphasis on enjoyment and accessibility can make participants more comfortable.

Since the PATH program doesn't involve new drugs or medical devices, it carries a lower risk of side effects compared to treatments that do. However, as with any exercise program, participants should consult their healthcare providers to ensure the activities suit their health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional obesity treatments that often rely on medication or surgery, the PATH Intervention is unique because it focuses on incorporating physical activity and education. Researchers are excited about this approach because it empowers individuals to adopt healthier lifestyles through tailored exercise plans and educational support, potentially leading to sustainable weight loss and improved overall health. This method emphasizes behavior change and personal empowerment, which could offer a more holistic and long-term solution compared to conventional treatments.

What evidence suggests that the PATH intervention could be effective for obesity?

Studies have shown that physical activity (PA) can greatly improve overall health, even without weight loss. Research indicates that being active lowers the risk of heart disease and diabetes, common conditions in people with obesity. Programs focusing on fun and easy activities tend to attract and retain more participants. In this trial, participants may be assigned to the PATH intervention, which aims to boost fitness and well-being by addressing challenges like stigma and low self-confidence. This method encourages better health, especially in diverse groups, by promoting regular physical activity as a lifestyle change rather than focusing solely on weight loss. ^{6 7 8 9 10}

Who Is on the Research Team?

Jacob Kariuki, PhD, NP

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You don't follow the recommended amount of exercise each week.

You have a body mass index (BMI) of 30 or higher.

You need to be able to use the Internet regularly.

Exclusion Criteria

I am not involved in any health-related lawsuits and do not need supervised physical activity.

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

I have been diagnosed with type 2 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the PATH intervention, which includes walking, dance, and abdominal core workouts

12 weeks

Self-directed with virtual check-ins

Follow-up

Participants are monitored for changes in adipocytokines and other health markers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PATH Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: PATH Intervention Experimental Treatment 3 Interventions

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

Group II: Control Group Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Georgia Center for Diabetes Translation Research

Collaborator

Trials

5

Recruited

200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7887033/

Evaluation of Intervention Components to Maximize ... Figure 1 summarizes the purported mechanisms for the intervention components to be tested, including weight loss self-efficacy, implementation of dietary skills ...

2. nature.com nature.com/articles/s41366-025-01742-4

Five-year follow-up of a randomized weight loss trial on ... The trial demonstrated that one-year treatment with HBCSS was effective for weight loss, and remarkably, the weight loss result was maintained ...

3. cdc.gov cdc.gov/pcd/issues/2024/23_0347.htm

Weight Loss in Short-Term Interventions for Physical ... This meta-analysis of 14 RCTs found that interventions lasting 6 months or less were effective at achieving weight loss. Each study showed ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10482795/

The Effectiveness of eHealth Interventions for Weight Loss ... Behavioral weight management interventions have been found to result in approximately 2–2.5 kg more weight loss than control conditions at the 12–18 month mark ...

5. bmj.com bmj.com/content/377/bmj-2021-069719

systematic review and meta-analysis of randomised ... Although the 2.3 kg greater weight loss in the intervention group may seem modest, just 2-5% in weight loss is associated with improvements in ...

6. pmc.ncbi.nlm.nih.gov pmc.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.

7. researchprotocols.org researchprotocols.org/2025/1/e67972

Protocol for a Pilot Randomized Controlled Trial The PATH intervention offers a promising, evidence-based approach to overcoming the barriers that have hindered previous PA programs for adults with obesity.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2451847625000776

Artificial Intelligence for Obesity Management: A Review of ... The review explores AI-based diagnostic tools utilising computer vision for body composition analysis, predictive algorithms identifying high- ...

9. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-022-01167-0

A group-based behavioural intervention for weight ... Safety data. Safety data will be ... National Institute for Health and Care Excellence: Obesity: identification, assessment and management.

10. nature.com nature.com/articles/s41366-023-01415-0

Efficacy of an app-based multimodal lifestyle intervention ... This study aimed to examine the effect of a digital multimodal weight loss intervention program delivered by an app on body weight in persons with obesity.