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

Lifespan

Status: Enrolling

Conditions: Obesity

Treatments: Behavioral: Yoga; Behavioral: Health and Wellness; Behavioral: Internet-based weight loss program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06166225

1947629

R01AT011868 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

All individuals enrolled in this study will receive a 12-month Internet-based weight loss program, consisting of a 3-month weight loss program, followed by a 9-month weight loss maintenance program. Each week during the first 3 months individuals will be asked to view a 10 to 15-minute multi-media lesson. These lessons focus on behavioral principles for changing diet and physical activity behaviors. Participants are also given weight loss, calorie intake, and physical activity goals. They are taught how to self-monitor this information and are instructed to submit it weekly on the study website. Automated, weekly individualized feedback is provided. Following the 3-month weight loss program participants will receive a 9-month weight loss maintenance program. During this time, they will be asked to view monthly video lessons which focus on strategies for successful weight loss maintenance and be instructed to continue to self-monitor weight, calorie intake, and physical activity minutes on the study website. Automated, monthly feedback is provided.

In addition, participants completing the 3-month weight loss program will be randomly assigned to receive either 9 months of Iyengar yoga classes or 9 months of health and wellness classes. These classes will be held twice per week (live via Zoom) for 14 weeks and then once per week thereafter.

To evaluate the program, participants are asked to complete assessments prior to starting the program (baseline) and at 3, 6, 12 (post-treatment), and 18 months (6 months after completion of the program). For these assessments, participants will be asked to weigh themselves on their study scale, complete a series of online surveys, wear a physical activity monitor for 10 days, and answer daily surveys on their smartphone for 10 days.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Internet-based weight loss program + Iyengar yoga

Experimental group

Description:

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.

Treatment:

Behavioral: Internet-based weight loss program

Behavioral: Yoga

Internet-based weight loss program + health and wellness classes

Active Comparator group

Description:

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:

Behavioral: Health and Wellness

Behavioral: Internet-based weight loss program