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Behavioral Intervention

Strategies for Weight Loss

N/A

Recruiting

Research Sponsored by The Miriam Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

History of bariatric surgery

Inability to walk 2 blocks without stopping

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare how well yoga and health classes help people lose weight over 12mos with an online program. Assessments will measure weight, eating, activity, and psychosocial factors.

Who is the study for?

The PATH Trial is for adults with a BMI of 25-40 who have regular internet access and own a smartphone. It's not suitable for those currently pregnant, planning pregnancy soon, or recently gave birth; anyone in recent weight loss programs or practicing yoga/meditation; individuals with certain medical conditions; recent significant weight losers; users of weight loss meds; post-bariatric surgery patients; or those unable to walk short distances.

What is being tested?

This study tests if adding online yoga classes enhances the effectiveness of an automated Internet-based weight loss program compared to health and wellness classes. Participants will first undergo 3 months of the weight loss program before being randomly assigned to one of the two additional class types for another 9 months.

What are the potential side effects?

While this trial does not involve medication, participants may experience typical side effects associated with starting new exercise routines such as muscle soreness or strain from yoga. The psychological impact varies but can include increased stress if lifestyle changes become overwhelming.

Eligibility Criteria

Exclusion Criteria

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

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I have had weight loss surgery in the past.

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I can't walk 2 blocks without stopping.

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I am currently on medication to lose weight.

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I have lost 10 or more pounds in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Affect

Behavioral inhibition

Dietary lapses

+6 more

Other study objectives

Percent weight change

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

Active Control

Group I: Internet-based weight loss program + Iyengar yogaExperimental Treatment2 Interventions

Participants randomized to this group will receive a 12-month automated weight loss program which is delivered via the Internet and will also receive a 9-month Iyengar yoga intervention (delivered during months 4-12). Yoga classes will be delivered live (via Zoom) and participants will be instructed to attend two classes per week for the first 14 weeks and one class per week thereafter. They will also be asked to do self-guided yoga practice on their own and report their yoga practice on the study website.

Group II: Internet-based weight loss program + health and wellness classesActive Control2 Interventions

Participants randomized to this group will receive a 12-month automated weight loss program which is delivered via the Internet and will also receive a 9-month health and wellness intervention (delivered during months 4-12). Health and wellness classes will be delivered live (via Zoom) and participants will be instructed to attend two classes per week for the first 14 weeks and one class per week thereafter. Classes will consist of lectures, videos, and discussions and will provide education around a variety of lifestyle topics.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Internet-based weight loss program

2019

N/A

~460

Yoga

2008

Completed Phase 3

~3830