Clinical trial NCT06166225: Strategies for Improving Remote-based Weight Loss (PATH Trial)
Official title: A Remote-based Yoga Intervention for Improving Long-term Weight Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: yoga
weight loss
exercise
diet
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-12-12
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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%

Primary outcomes:
measure: Percent weight change
timeFrame: 12 months
Secondary outcomes:
measure: Dietary lapses
timeFrame: 12 months
measure: Affect
timeFrame: 12 months
measure: Dietary temptations
timeFrame: 12 months
measure: Percentage of time that tempting foods were eaten
timeFrame: 12 months
measure: Dispositional mindfulness
timeFrame: 12 months
measure: Distress tolerance
timeFrame: 12 months
measure: Self-compassion
timeFrame: 12 months
measure: Behavioral inhibition
timeFrame: 12 months
measure: Self-efficacy
timeFrame: 12 months
Other outcomes:
measure: Percent weight change
timeFrame: 18 months
Locations:
city: Providence
country: United States
facility: The Miriam Hospital's Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
References: