The PATH Trial is a randomized clinical trial funded by the National Center for Complementary and Integrative Health (R01AT011868) and is registered on ClinicalTrials.gov (NCT06166225). While the trial is entirely remote, the study will be conducted out of the Weight Control and Diabetes Research Center in Providence, Rhode Island. The Weight Control and Diabetes Research Center is a joint research institution affiliated with Brown University Health and The Warren Alpert Medical School at Brown University.

All study procedures were developed in accordance with the Declaration of Helsinki ethical principles and approved by the institutional review board at Brown University Health (IRB # 1947629). Participants will be asked to complete informed consent via REDCap (Research Electronic Data Capture; Vanderbilt University) after attending an online study orientation session with a member of the research team. Participants will be eligible for compensation up to US $75 in the form of a gift card for the completion of assessments at 3, 6, 12, and 18 months. The US $75 compensation is calculated in the following manner: participants will receive US $25 for completing the online questionnaires and wearing the PA monitor; they will also be compensated US $0.50 for each ecological momentary assessment (EMA) survey completed (50 surveys per assessment period) and will receive a US $25 bonus for EMA compliance >80%. No compensation will be provided for the baseline assessment visit. The full study protocol, informed consent document, and study results will be published on ClinicalTrials.gov upon study completion. To protect participant confidentiality, all study data collected via our secure website using an active Secure Sockets Layer or Transport Layer Security certificate (HTTPS), or other platforms, will be securely stored on institutionally managed, access-controlled servers protected by firewalls, multifactor authentication, and regular security monitoring. All physical data will be stored securely in locked cabinets, with access strictly limited to authorized and trained study personnel.

This protocol is reported in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2025 guidelines for randomized trials, and any significant modifications to the protocol will require prior approval from the study sponsor. An overview of the study design is shown in Figure 1. A total of 210 participants will enroll in this randomized controlled clinical trial with a parallel-group design and equal allocation. All participants will receive a 12-month IDWL program, and those completing the 3-month assessment visit will be randomized to receive (1) a 9-month yoga program (YOGA; delivered during months 4‐12) or (2) a 9-month contact-matched control “Health & Wellness program” (WELLNESS; delivered during months 4‐12). The choice to delay randomization to YOGA or WELLNESS until after the 3-month assessment, rather than at baseline, was made to give participants time to build foundational WL skills without added burden and to reinforce self-regulatory skills at a time (3 months) when WL-related motivation may begin to dip [7,52]. Additional rationale to delay randomization to YOGA or WELLNESS is provided in the discussion. A full description of all intervention components is detailed below and conforms with the TiDieR (Template for Intervention Description and Replication) checklist for intervention reporting to enhance clarity and replicability.

Yoga and wellness classes will be delivered via videoconferencing software (ie, Health Insurance Portability and Accountability Act [HIPAA]–compliant Zoom; Zoom Video Communications). There will be no intervention during months 13‐18. Randomization will occur at the 3-month assessment (ie, 3 months into the IDWL) in equal numbers based on a permuted block randomization procedure with small, random sized blocks, stratified by biological sex, racial or ethnic minority status, and percent WL achieved during the first 3 months of the WL program (<5% vs ≥5% WL). The randomization scheme was generated by the study statistician using R Studio (version 3.6.0) and uploaded into REDCap directly (to ensure study staff was kept blinded toward the full schematic). Participants will be recruited in cohorts over the study period. Assessments of weight, aerobic PA minutes, dietary lapses, potential lapse triggers (eg, affect, craving, and dietary temptations), and self-regulation mediator variables will be measured at baseline, 3 months (just prior to randomization), 6 months (mid-treatment), 12 months (postintervention), and 18 months (following a 6-month period of no intervention). At each assessment period, data will be collected via a series of REDCap questionnaires, an Actigraph accelerometer, and a 10-day EMA protocol (ie, 5 surveys per day over 10 days with each survey taking 2‐5 minutes to complete).

The primary aim of the PATH Trial is to compare the treatment effects of IDWL and YOGA versus IDWL and WELLNESS on weight change at 12 months. The primary weight outcome is absolute weight change from baseline to 12 months. It is hypothesized that WL will be greater in those randomized to the YOGA when compared to WELLNESS.

Secondary aims of this study are (1) to compare YOGA and WELLNESS at 12 months on dietary lapses and potential lapse triggers as assessed via EMA and (2) to examine self-regulation mediators (eg, mindfulness, self-compassion, distress tolerance, self-efficacy, and inhibitory control) of the treatment effect on primary (ie, weight change) and secondary outcomes (ie, dietary lapses) at 12 months.

Exploratory aims are to examine the long-term (18 months) effects of yoga on primary and secondary outcomes, to explore potential moderators (3-month WL, race or ethnicity, biological sex, and BMI) of the treatment effect on weight change, and to explore the effect of yoga on participation in aerobic exercise.

A total of 210 WL-seeking male and female individuals will be recruited for this study. Specifically, participants will be between the ages of 18 and 65 years and have a BMI of 25‐40 kg/m², regardless of race or ethnicity. Participants must own a smartphone (for EMA surveys) and have daily, home internet access that allows for videoconferencing. Exclusion criteria will include 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 WL program; current or recent yoga, meditation, or mindfulness practice, either at home or in a studio (participants who reported ≥12 sessions within the past 2 years will be followed up with to confirm eligibility); presence of any medical condition for which yoga, exercise, WL, or dietary restriction is contraindicated (Physical Activity Readiness Questionnaire); recent WL (≥4.5 kg within the past 6 months); currently taking WL medications or history of bariatric surgery; inability to walk 2 blocks without stopping; failure to complete all baseline assessment procedures; and baseline EMA compliance <80% (to be used as an indicator of behavioral adherence). To ensure safety, individuals with a history of heart disease, diabetes, cancer, or major orthopedic conditions will be required to provide physician consent prior to enrolling.

Participants will be recruited through online advertisements via social media outlets. Participants will be asked to respond to advertisements by completing an online screener linked to the advertisement. Participants will be recruited in 5 cohorts with a targeted cohort size of 35‐60 participants. Individuals who meet all inclusion criteria and are eligible to participate in the study will be invited to attend a study orientation (delivered via Zoom), in which the study will be explained in greater detail. Individuals who attend orientation and remain interested in participating in the study will be emailed a link to complete informed consent via REDCap [53]. Data will be collected and managed using the REDCap tools hosted at Brown University Health’s Department of Information Services. REDCap is a secure, web-based application designed to support data capture for research studies. Once consent is obtained, participants will begin the baseline assessment, which consists of study questionnaires, an EMA protocol, and wearing an accelerometer. Further, as part of the assessment, participants are required to attend a one-on-one behavioral interview via videoconference with a member of the research staff to ensure that the participant is willing to commit to all study procedures prior to beginning the WL program.

All participants will receive a 12-month, fully automated IDWL program, which has been used in previous trials [7,54,55]. Prior to the start of the program, participants will be asked to watch a brief video, which will provide them with the basics for navigating the study website. The goal of the program is to induce a 1‐2 lb (~0.5‐1 kg) WL per week. To assist in achieving this goal, individuals will be given an initial daily calorie intake goal of 1200‐1800 kcal per day depending upon starting weight. Participants will also be taught to increase or decrease calorie intake as necessary based on WL progress and goals. There will be also a moderate-intensity aerobic exercise (eg, walking, cycling, and elliptical) goal, which progresses to 150 minutes per week. Participants will be instructed to self-monitor body weight, energy intake, and PA daily over the 12-month WL period, as self-monitoring in a behavioral WL program has been shown to be associated with weight change [56]. They will be provided with a smart scale, which will allow for wireless [57] transmission of weight data to the study website. Participants will be given the option to track their calories and exercise minutes in the Fitbit mobile app, in which case data will automatically transfer to the study website through an application programming interface built specifically for this study. However, if they use a different tracking method, they will be asked to manually input their daily calorie intake and exercise minute totals on the study website. Computer-generated, personalized feedback will be provided using these self-report data. Participants will also be instructed to view 10‐ to 15-minute multimedia lessons, which are modeled after the Look AHEAD Trial [57]. Example lesson topics including strategies for increasing PA, eating out at restaurants, and problem-solving. Video lessons and automated feedback are provided weekly during the first 3 months of the IDWL program and monthly during months 4‐12. Participants also have access to healthy recipes and tip sheets (eg, meal planning strategies, eating healthy on a budget, and exercising safely) via the study website. During months 4‐12, automated text messages, which are informational and motivational in nature, will also be sent to participants twice per month and will differ between yoga and wellness conditions.

Upon completion of the 3-month assessment visit, participants randomized to WELLNESS will receive a 9-month fully remote, health and wellness program. Similar to YOGA, wellness classes will be approximately 60 minutes in duration and held multiple times per week. Participants will be instructed to attend 2 classes per week for the first 14 weeks and 1 class per week until the 12-month study assessment (22 weeks). Classes will be taught by individuals with a bachelor’s degree or higher in a wellness-related field (eg, nutrition, exercise science, health promotion, and psychology). Classes will consist of lectures, handouts, videos, and discussions addressing a variety of health and lifestyle topics, which include immune health, sleep recommendations, health screenings, healthy aging, vitamins and minerals, and humor and health. WL will not be discussed within these sessions, and participants will be informed that wellness classes are designed to function independently of the IDWL program. Overall, the WELLNESS condition provides a treatment program, which serves as a contact-matched control for the yoga arm.

All live intervention sessions (YOGA and WELLNESS) will be audio-recorded using a HIPAA-compliant version of Zoom. Recordings will be downloaded weekly and stored on a secure server. On a quarterly basis, 15% of all completed class recordings will be assessed for treatment fidelity via checklists developed by the research team for the YOGA and WELLNESS classes. These checklists include items such as class duration, whether the instructor taught the class as intended, and whether there was an opportunity for participants to ask questions. Fidelity will be assessed by a member of the research team who does not interact with participants. If at any time fidelity is <80%, teachers will be retrained and instructed on how to implement any necessary changes.

At each assessment, a series of questionnaires will be completed via REDCap. At baseline only, demographic information and food insufficiency will be assessed. Questionnaire measures of self-regulatory mechanisms are found in Table 3 and will be completed at all assessment time points by all participants. At follow-up time points, program satisfaction questionnaires will also be completed, which will be used to assess the acceptability of the IDWL, yoga, and wellness programs. Yoga participants will also be asked to complete several additional questionnaires at follow-up related to their perception of the yoga classes, perceived benefits of practicing yoga [59], and frequency and duration of yoga practice.

Minutes of aerobic PA will be objectively measured for 10 days, at each assessment period, using the previously validated Actigraph accelerometer [68]. Participants will be mailed an accelerometer, provided with instructions on how to wear the device, and be instructed to wear the Actigraph on their waist during all waking hours, except for water-related activities. They will also be asked to keep a log to record when they put the device on, took it off, and any exercise that they may have performed while not wearing the device. When processing the data, only “valid” days (ie, ≥8 hours of Actigraph wear time) will be considered in the analysis. Minutes per day spent in total and bout-related (≥10-minute bouts) moderate-to-vigorous intensity PA will be calculated using validated methods. One common critique of yoga as a WL intervention is that yoga participation may reduce aerobic PA. By objectively assessing PA, this study will be able to empirically answer this question. Upon study completion, at the time of analysis for this study, we will use all recommended processing methods for all accelerometry data and report findings accordingly.

Intervention adherence will include the percentage of IDWL lessons viewed and frequency of self-monitoring energy intake, weight, and aerobic exercise minutes entered into the study website (or transmitted to the study website via the Fitbit app) by participants over the study duration. Attendance at live yoga and wellness classes will also be assessed. Additional adherence metrics in the yoga condition include the number of times each prerecorded yoga video was viewed and weekly minutes per week of yoga practice (reported on the study website). During months 13‐18, self-reported yoga practice will be assessed via monthly surveys.

Upon study enrollment, participants will be instructed to contact the study staff should they experience any illnesses, injury, or side effects that are distressing to them throughout the 18-month research study. Moreover, each month, randomized participants will be required to complete a brief survey, which asks about any injuries or illnesses over the past month. Should a participant report an injury or illness on this survey, they will be contacted by the research staff to gather more information. Finally, at each assessment period (3, 6, 12, and 18 months), participants will be asked to report any illnesses, injuries, changes in health status, and medications experienced since the previous assessment. All adverse events (AEs; any untoward medical occurrence in a person that is temporarily associated with participation in the clinical study) will be reported by the principal investigator (JU) to the institutional review board, the trial’s data safety monitoring board, and funding sponsor. Serious AEs (any AE that results in 1 or more of the following: death, life-threatening event, inpatient hospitalization, persistent or significant disability or incapacity, and important medical event based on appropriate medical judgment) will be reported within 24 hours. All other AEs will be reported twice yearly and will be included within regular reporting to the data safety monitoring board (consisting of external reviewers who have been approved by the study sponsor).

This paper provides a summary of the rationale and methods of the PATH Trial. The primary goals of this randomized trial are to examine whether the addition of yoga to behavioral WL treatment improves long-term WL and to elucidate mechanisms through which yoga impacts weight in WL-seeking adults. These findings will have clinical relevance, as overweight and obesity are global health challenges linked to cardiometabolic risks, and despite effective WL interventions, long-term WL remains difficult [35,36]. Therefore, it is crucial to identify and test novel strategies, such as yoga, which have the potential to support sustained WL.

This study results from a synthesis of literature from a variety of disciplines using yoga interventions (cardiometabolic, pain, and addiction fields) and proposes a unique application of yoga to the area of weight management. While these other disciplines tend to focus on the psychological benefits of yoga for improving health, the weight control field has traditionally viewed yoga as a “mode” of exercise and has failed to consider that yoga is a mind-body intervention that could indirectly impact weight via psychological mechanisms (eg, improvements in self-regulation). Therefore, it is important to delineate that a yoga practice is not an exercise modality that produces effects similar to aerobic exercise, which has a higher caloric expenditure and is commonly recommended in WL programs, and therefore will be unlikely to elicit a comparable exercise-induced energy deficit [69]. Unlike past literature, this trial is uniquely designed and fully powered to evaluate self-regulatory pathways through which yoga impacts dietary lapses and WL, representing the first RCT to examine these mechanistic pathways within the context of WL treatment.

This design was chosen as the best method of answering the questions central to the study. For example, the use of an equal contact-time wellness program for the control arm, delivered through the same live, synchronous videoconferencing modality as yoga, provides a stringent test of the relative efficacy of yoga as a complementary therapy to IDWL. The decision to implement yoga at the start of week 14, rather than week 1, was made so that participants can dedicate their focus to initiating important WL skills and achieving program goals at the start of the program (eg, regular self-weighing, self-monitoring, calorie restriction, and aerobic exercise). Adding yoga at week 1 would further increase participant burden, which is already high at this time. Delaying yoga until week 14 allows additional time for these important WL skills to become more routine, which then allows individuals more time to dedicate to practicing yoga. Further, given that maximal WL in IDWL programs is achieved around 3 months [7,52] (earlier than what is observed with in-person treatment [35]), one way to bolster WL at this time would be to add an intervention component, which can both add novelty and strengthen self-regulation. Research supports this approach, as individuals report that over time, boredom increases; it requires more effort to stay on track, and the cost-benefit ratio for WL increases (ie, the effort required to adhere to WL practices is greater than the positive feedback received for adherence) [35,70-74]. This makes continued diligence to self-regulatory WL behaviors challenging, particularly during times of high stress, emotional difficulties, or when exposed to highly palatable foods. Our pilot study, which also implemented yoga following a period of WL treatment, provided further support for this decision [51].

This study is novel, in that it is one of a handful of studies to combine yoga with a WL program, and it is the first to empirically examine this combination of approaches using fully remote intervention procedures (ie, IDWL combined with live, online yoga classes). We made the decision to combine yoga with IDWL treatment from months 4 to 12 (vs stopping IDWL treatment) for the following reasons. First, most WL programs are 1 year in duration, and there is no added cost to continuing the IDWL program, given that it is fully automated. Additionally, as prior research suggests that yoga reinforces self-regulatory skills taught within IDWL, extending the IDWL treatment would provide an opportunity for participants to “practice” these skills. Finally, this approach allows for examination of the combined effect of yoga and IDWL.

Another novel aspect of this study is the use of technology-based assessment methods (EMA) for capturing participants’ dietary lapses and potential lapse triggers (eg, cravings, temptations, and affect) in near-real-time, within a naturalistic setting, while participating in a WL and yoga intervention. We also pair these survey assessment methods with objective monitoring of aerobic PA, so that they occur simultaneously. While pilot work indicates that yoga participation does not reduce aerobic exercise engagement [4], this is a frequent concern regarding the inclusion of yoga into a WL program. Thus, this study will be able to empirically answer whether including yoga reduces engagement in other modalities of exercise while also allowing for novel exploratory analyses related to both the acute and chronic effects of yoga on psychological and dietary variables.

This study will also add to the literature in its ability to examine for whom yoga is most efficacious for producing WL. Examination of yoga within the context of a weight management program is in its infancy, and studies assessing the effect of yoga on body weight have been primarily in the normal weight, non-Hispanic, White female population. This study seeks to enroll ≥35% male individuals and ≥40% individuals from racial and ethnic groups that are commonly underrepresented in WL trials. Thus, we will be in a unique position to explore whether the effect of yoga on WL differs by biological sex and race or ethnicity or whether there are other significant moderators (eg, BMI, 3-month WL, and socioeconomic status) of the effects of yoga on WL. To our knowledge, this is the first study to examine whether there are specific subgroups of WL-seeking individuals who benefit most from yoga participation.

The proposed study is significant because it is one of the few trials to examine the combined effect of yoga and WL treatment among individuals with overweight or obesity and the first fully powered trial to assess the combination of yoga and WL beyond 6 months. While the yoga field is often criticized for a lack of scientific rigor, this study represents a significant step toward improving the quality of research in this area, as it is empirically guided and thoughtfully designed to ensure rigor and reproducibility of study findings (eg, randomized trial with contact-matched control, manualized protocols, and fidelity checks). This study also uses and tests an easily disseminated intervention model, which combines a fully automated, low-cost IDWL program with live, online yoga classes; thus, translation potential is high. Examination of mediators and moderators of the effect of yoga on WL is also important for improving theoretical models of yoga and self-regulation, optimizing future intervention trials, and enhancing our understanding of how and for whom yoga impacts long-term WL. Ultimately, if primary hypotheses are confirmed, yoga could be considered a valuable intervention component for improving IDWL treatment. In the future, if favorable results are observed, longer-term follow-up would also be warranted to better understand the role of yoga in WL maintenance over periods of time longer than this study is planning. This study has great potential to make a significant contribution to both yoga and WL fields and addresses critical gaps in the current literature.