ObesityNCT06166225
Strategies for Improving Remote-based Weight Loss (PATH Trial)
A study testing Internet-based weight loss program, Yoga and Health and Wellness in people with Obesity, run by The Miriam Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Internet-based weight loss program, Yoga and Health and Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI: 25-40 kg/m2
- Must own smartphone and have daily, home Internet access
Who cannot join
- 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
Show all 9Show fewer
- History of bariatric surgery
- Inability to walk 2 blocks without stopping
- Baseline smartphone survey completion rate <80%
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miriam Hospital's Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based weight loss programBehavioural
12-month, automated and behaviorally-based, Internet-delivered weight loss and weight loss maintenance program
YogaBehavioural
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 WellnessBehavioural
9-month health and wellness program consisting of live (Zoom) yoga classes delivered 1-2 times per week during months 4-12.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based weight loss program + Iyengar yoga | Experimental | 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. Receives: Behavioral: Internet-based weight loss program; Behavioral: Yoga |
| Internet-based weight loss program + health and wellness classes | Active comparator | 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. Receives: Behavioral: Internet-based weight loss program; Behavioral: Health and Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent weight change
Weight change will be assessed via smart scales using weight at baseline and 12 months
Measured: 12 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Dispositional mindfulness
Mindfulness will be assessed via the Five Facet Mindfulness Questionnaire - Short Form at baseline and 12 months
Measured: 12 months
Distress tolerance
Distress tolerance will be assessed via the Distress Tolerance Scale at baseline and 12 months
Measured: 12 months
Self-compassion
Self-compassion will be assessed via the Self-Compassion Scale - Short Form at baseline and 12 months
Measured: 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.
Measured: 12 months
Self-efficacy
Self-efficacy will be assessed using the Weight Efficacy Lifestyle Questionnaire at baseline and 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start8 Jan 2024
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166225
- Sponsor's protocol ID
- 1947629
- Other IDs
- R01AT011868
- Status last verified
- May 2026
- First submitted
- 3 Dec 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Tobin SY, Sherman S, Bock B, Dunsiger S, Thomas JG, Goldstein SP, Unick J. PATH Trial for Examining Yoga as a Strategy to Improve Remote-Based Weight Loss in Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 25;15:e78973. doi: 10.2196/78973.
PubMed 41740089
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Remote-based Yoga Intervention for Improving Long-term Weight Loss
- ClinicalTrials.gov ID
- NCT06166225
- Acronym / sponsor ID
- 1947629
- Conditions
- Obesity
- Keywords
- yoga, weight loss, exercise, diet
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based weight loss program + Iyengar yoga | Experimental | Behavioral: Internet-based weight loss program, Behavioral: YogaParticipants 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. |
| Internet-based weight loss program + health and wellness classes | Active comparator | Behavioral: Internet-based weight loss program, Behavioral: Health and WellnessParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI: 25-40 kg/m2
- Must own smartphone and have daily, home Internet access
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based weight loss program12-month, automated and behaviorally-based, Internet-delivered weight loss and weight loss maintenance program | Behavioural | Internet-based weight loss program + Iyengar yoga, Internet-based weight loss program + health and wellness classes |
| Yoga9-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. | Behavioural | Internet-based weight loss program + Iyengar yoga |
| Health and Wellness9-month health and wellness program consisting of live (Zoom) yoga classes delivered 1-2 times per week during months 4-12. | Behavioural | Internet-based weight loss program + health and wellness classes |
Primary outcome
Percent weight change
Time frame: 12 months
Weight change will be assessed via smart scales using weight at baseline and 12 months
9 secondary outcomes
Dietary lapses
Time frame: 12 months
Affect
Time frame: 12 months
Dietary temptations
Time frame: 12 months
Percentage of time that tempting foods were eaten
Time frame: 12 months
Dispositional mindfulness
Time frame: 12 months
Distress tolerance
Time frame: 12 months
Self-compassion
Time frame: 12 months
Behavioral inhibition
Time frame: 12 months
Self-efficacy
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Derived from this study: PubMed 41740089Tobin SY, Sherman S, Bock B, Dunsiger S, Thomas JG, Goldstein SP, Unick J. PATH Trial for Examining Yoga as a Strategy to Improve Remote-Based Weight Loss in Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 25;15:e78973. doi: 10.2196/78973.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based weight loss program, Yoga and Health and Wellness in people with Obesity, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent weight change (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06166225, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.