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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Internet-based weight loss program; Behavioral: Yoga; Behavioral: Health and Wellness

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.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Unick, PhD; Phone Number: 401-793-8966; Email: junick@lifespan.org
• Study Contact Backup: Name: Jennifer Webster, BS; Phone Number: 401-793-8946; Email: jwebster@lifespan.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • The Miriam Hospital's Weight Control and Diabetes Research Center
      • Contact: Jessica Unick, PhD; Phone Number: 401-793-8966; Email: junick@lifespan.org
      • Principal Investigator: Jessica Unick, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-based weight loss program + Iyengar yoga; 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.	Behavioral: Internet-based weight loss program; 12-month, automated and behaviorally-based, Internet-delivered weight loss and weight loss maintenance program; Behavioral: 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.
Active Comparator: Internet-based weight loss program + health and wellness classes; 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.	Behavioral: Internet-based weight loss program; 12-month, automated and behaviorally-based, Internet-delivered weight loss and weight loss maintenance program; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent weight change	Weight change will be assessed via smart scales using weight at baseline and 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Dispositional mindfulness	Mindfulness will be assessed via the Five Facet Mindfulness Questionnaire - Short Form at baseline and 12 months	12 months
Distress tolerance	Distress tolerance will be assessed via the Distress Tolerance Scale at baseline and 12 months	12 months
Self-compassion	Self-compassion will be assessed via the Self-Compassion Scale - Short Form at baseline and 12 months	12 months
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
Self-efficacy	Self-efficacy will be assessed using the Weight Efficacy Lifestyle Questionnaire at baseline and 12 months.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

Helpful Links

• Trial website

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: December 3, 2023
• First Submitted That Met QC Criteria: December 3, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: exercise; yoga; weight loss; diet
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 1947629; R01AT011868 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will available to other researchers as raw individual-level data; however, this will not be available until the primary outcome papers from the study are accepted for publication. Requestors will be required to sign a data sharing agreement stating that: (1) They will use the data for research purposes only unless otherwise agreed, and will not identify any individual or personal information, (2) Data will be secured using appropriate technology/firewalls, (3) Data will be destroyed after data analysis, and (4) They will cite data appropriately in publications or other written materials. A record of transfer of data and a copy of the dataset that was distributed will be kept by The Miriam Hospital
• IPD Sharing Time Frame: Study data will be made available as soon as possible, but no later than within one year of the completion of the funded project period or upon acceptance of the data for publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No