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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06166225
• Other study ID #: 1947629
• Secondary ID: R01AT011868
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: March 30, 2028

Study information

• Verified date: December 2023
• Source: The Miriam Hospital
• Contact: Jennifer Webster, BS
• Phone: 401-793-8946
• Email: jwebster[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: March 30, 2028
• Est. primary completion date: March 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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%

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Internet-based weight loss program
12-month, automated and behaviorally-based, Internet-delivered weight loss and weight loss maintenance program
• Yoga
9-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.
• Health and Wellness
9-month health and wellness program consisting of live (Zoom) yoga classes delivered 1-2 times per week during months 4-12.

Locations

Country	Name	City	State
United States	The Miriam Hospital's Weight Control and Diabetes Research Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent weight change	Weight change will be assessed via smart scales using weight at baseline and 18 months to examine the long-term effects of the interventions.	18 months
Primary	Percent weight change	Weight change will be assessed via smart scales using weight at baseline and 12 months	12 months
Secondary	Dietary lapses	Dietary lapses will be assessed via ecological momentary assessment (EMA). Participants receive EMA surveys 5x/day, for 10 days, at baseline and 12 months, and surveys ask about any dietary lapses since completing the last survey.	12 months
Secondary	Affect	Affect will be assessed via ecological momentary assessment (EMA). Participants receive EMA surveys 5x/day, for 10 days, at baseline and 12 months, and surveys ask about current affect.	12 months
Secondary	Dietary temptations	Dietary temptations will be assessed via ecological momentary assessment (EMA). Participants receive EMA surveys 5x/day, for 10 days, at baseline and 12 months, and surveys ask about dietary temptations experienced since the last prompt.	12 months
Secondary	Percentage of time that tempting foods were eaten	Dietary temptations will be assessed via ecological momentary assessment (EMA). Participants receive EMA surveys 5x/day, for 10 days, at baseline and 12 months, and surveys ask about dietary temptations experienced since the last prompt. If a temptation is reported, participants are asked to state whether they ate the tempting food. The percentage of time that tempting foods were eaten (vs. not eaten) will be calculated.	12 months
Secondary	Dispositional mindfulness	Mindfulness will be assessed via the Five Facet Mindfulness Questionnaire - Short Form at baseline and 12 months	12 months
Secondary	Distress tolerance	Distress tolerance will be assessed via the Distress Tolerance Scale at baseline and 12 months	12 months
Secondary	Self-compassion	Self-compassion will be assessed via the Self-Compassion Scale - Short Form at baseline and 12 months	12 months
Secondary	Behavioral inhibition	Behavioral inhibition will be assessed via the Behavioral Inhibition System and Behavioral Activation System (BIS/BAS) Questionnaire at baseline and 12 months and the BIS subscale will be assessed.	12 months
Secondary	Self-efficacy	Self-efficacy will be assessed using the Weight Efficacy Lifestyle Questionnaire at baseline and 12 months.	12 months

External Links

•   Trial website