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Behavioural Intervention
Physical Activity & Education for Obesity
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months after screening procedures start
Awards & highlights
Study Summary
This trial will study how enjoyable, less exhausting activities can help individuals with obesity reduce cardiometabolic risks, regardless of weight loss.
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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to protocol procedures
Attainment of recruitment goal
Participants' satisfaction of protocol procedures (acceptability)
+1 moreSecondary outcome measures
Changes in Monocyte Chemoattractant Protein-1 (MCP-1)
Changes in T2D risk score
Changes in adiponectin and leptin
+1 moreOther outcome measures
Change in exercise self-efficacy questionnaire (EXSE)
Change in exercise self-regulation
Change in the Outcome Expectations for Exercise Scale questionnaires.
+2 moreTrial 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
PATH Intervention
2021
N/A
~80
Control Group
2012
Completed Phase 2
~2470
Dietary education
2015
N/A
~70
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.
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,315,540 Total Patients Enrolled
453 Trials studying Obesity
588,918 Patients Enrolled for Obesity
Emory UniversityLead Sponsor
1,652 Previous Clinical Trials
2,572,788 Total Patients Enrolled
21 Trials studying Obesity
15,672 Patients Enrolled for Obesity
American Diabetes AssociationOTHER
141 Previous Clinical Trials
99,761 Total Patients Enrolled
24 Trials studying Obesity
1,617 Patients Enrolled for Obesity
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