Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06166225

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

A Remote-based Yoga Intervention for Improving Long-term Weight Loss

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
210 (estimated)
Sponsor
The Miriam Hospital · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALInternet-based weight loss program12-month, automated and behaviorally-based, Internet-delivered weight loss and weight loss maintenance program
BEHAVIORALYoga9-month Iyengar yoga program consisting of live (Zoom) yoga classes delivered 1-2 times per week during months 4-12, and self-guided yoga practice recommendations.
BEHAVIORALHealth and Wellness9-month health and wellness program consisting of live (Zoom) yoga classes delivered 1-2 times per week during months 4-12.

Timeline

Start date
2024-01-08
Primary completion
2028-03-30
Completion
2028-03-30
First posted
2023-12-12
Last updated
2025-05-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06166225. Inclusion in this directory is not an endorsement.