Strategies for Improving Remote-based Weight Loss (PATH Trial)

RECRUITING

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The purpose of this study is to examine whether the addition of online yoga classes, compared to health and wellness classes, can improve the amount of weight loss produced from an Internet-based weight loss program. All individuals will receive a 12-month, automated Internet-based weight loss program. Following 3 months of of weight loss treatment, individuals will be randomized to also receive yoga classes or health and wellness classes for 9 months. Assessments will occur at baseline, 3, 6, 12, and 18 months and will include measures of weight, eating behaviors, physical activity, and psychosocial factors.

Conditions:

🦠 Obesity

🗓️ Study Start (Actual) 8 January 2024

🗓️ Primary Completion (Estimated) 30 March 2028

✅ Study Completion (Estimated) 30 March 2028

👥 Enrollment (Estimated) 210

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Providence, Rhode Island, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

* BMI: 25-40 kg/m2
* Must own smartphone and have daily, home Internet access

Exclusion Criteria:

* Currently pregnant, planning to become pregnant within the next 18 months, or pregnant within the past 6 months
* Current or recent enrollment (\<2 years) in a weight loss program
* Current or recent yoga, meditation, or mindfulness practice, either at home or in a studio (defined as ≥12 sessions within the past 2 years)
* Presence of any medical condition for which yoga, exercise, weight loss, or dietary restriction is not recommended
* Recent weight loss (≥10 pounds within the past 6 months)
* Currently taking weight loss medications
* History of bariatric surgery
* Inability to walk 2 blocks without stopping
* Baseline smartphone survey completion rate \<80%

Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 3 December 2023
First Submitted that Met QC Criteria 3 December 2023
First Posted 12 December 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 29 February 2024
Last Update Posted 4 March 2024
Last Verified December 2023