ObesityNCT06393725
Synchronous vs Asynchronous Remotely Delivered Lifestyle Interventions
A study testing Asynchronous Remote Lifestyle Intervention and Synchronous Remote Lifestyle Intervention in people with Obesity, run by University of Connecticut at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a group-based digital weight loss program that is delivered asynchronously (via an online platform) is as effective as one that is delivered synchronously (via weekly videoconference meetings). 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?
- Asynchronous Remote Lifestyle Intervention and Synchronous Remote Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2025to 30 Jun 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 27-45
- has Bluetooth or wifi connectivity at home (for scale)
- goes on Facebook at least 5 days per week over the past 2 weeks
- has posted/replied at least once a week in the past 2 weeks (per self-report)
- has a smart phone
Who cannot join
- Pregnant or lactating or plans to during study period
- bipolar disorder, substance abuse, psychosis, bulimia, binge eating disorder, or severe depression
- had bariatric surgery or plans to during the study
- currently taking meds affecting weight
- lost ≥5% of weight in past 6 months
- participating in another weight loss program or plans to during the study
Show all 10Show fewer
- chronic pain or medical condition that interferes with the ability to exercise
- type 1 diabetes
- unable to walk ¼ mile unaided without stopping
- nicotine user
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: A Non-Inferiority Trial Comparing Synchronous and Asynchronous Remotely Delivered Lifestyle Interventions
The goal of this clinical trial is to learn if a group-based digital weight loss program that is delivered asynchronously (via an online platform) is as effective as one that is delivered synchronously (via weekly videoconference meetings). In the asynchronous condition, participants can engage with their group any time 24/7. In the synchronous condition, participants can engage with their group once a week at a videoconference meeting. The main questions it aims to answer are:
Will participants in each condition lose about the same amount of weight? Will the participants in the asynchronous condition participate more than those in the synchronous condition? Will the participants in the asynchronous condition feel more connected to each other than those in the synchronous condition? Will the asynchronous condition cost less to deliver per pound lost than the synchronous condition?
Read more
Participants will:
Receive a digital weight loss program that lasts 1 year and then volunteer participants will be selected to lead the group for 1 year following the program, a phase called the "peer-led weight loss maintenance phase." Complete study assessments at baseline, 6, 12, 18, and 24 months.
Read the detailed description
Lifestyle interventions have had established efficacy for decades but they are costly and have poor scalability. Remotely-delivered lifestyle interventions have increased the potential for scale and systematic reviews have found that they are effective, especially those that include human coaching. Some remote lifestyle interventions are synchronous, such that they are delivered via videoconferencing or phone. Other remote lifestyle interventions are asynchronous, such that they are delivered via online platforms that allow for clinicians and patients to engage via text exchanges or via online groups where patients engage with a clinician and each other by posting messages and contributing to discussion threads. The advantage of asynchronous approaches are 24/7 accessibility which makes them conducive to "just in time" support, allowing patients to engage anytime they want to, as opposed to in scheduled blocks of time each week. Asynchronous, remote interventions may also be more scalable than synchronous remote interventions. A trial of two asynchronous, remote lifestyle interventions-one with a group of 94 participants and one with a group of 40 participants revealed similar weight loss and acceptability between conditions. The larger group was also more sustainable, such that participants continued to engage in the group for longer when the groups were turned over to participants to lead themselves for a year after the intervention ended-a period referred to as the peer-led maintenance phase. The next step in this research is to examine how an asynchronous, remote intervention compares to a synchronous, remote intervention, not only in short term weight loss, but also in sustainability, scalability, and weight loss maintenance. Now that the feasibility of conducing large asynchronous, remote groups has been established, the proposed trial will randomize participants to large groups (n=82) in both conditions, which will allow the comparison of synchronous to asynchronous remote interventions that are scaled up to a level established as acceptable for asynchronous remote interventions. The purpose of the proposed trial is to determine whether an asynchronous, remote lifestyle intervention is non-inferior to a synchronous, remote lifestyle intervention in weight loss at 6 and 12 months, but more scalable and sustainable, and thus producing greater weight loss maintenance at 18 and 24 months. Establishing evidence for asynchronous interventions is more important than ever given that telehealth reimbursement for behavioral health has recently expanded but is still limited to synchronous forms of remote care. Asynchronous interventions may be more convenient for some people and possibly more scalable but for this treatment model to reach its potential, evidence for efficacy is needed to inform reimbursement policy. The hypothesis is that an asynchronous, remote lifestyle intervention will produce similar initial weight loss as a synchronous, remote version but will be less expensive, more sustainable, and generate greater collective efficacy, which will drive greater weight loss maintenance at 18 and 24 months.
- Conditions
- Obesity
- Being tested
- Asynchronous Remote Lifestyle Intervention, Synchronous Remote Lifestyle Intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asynchronous Remote Lifestyle InterventionBehavioural
A 1 year lifestyle intervention based on the Diabetes Prevention Program to be delivered asynchronously via a private Facebook group led by a professional weight loss counselor. In the subsequent year, a Peer-Led Maintenance Phase will occur in which a participant volunteer will lead the group after receiving a brief training.
Synchronous Remote Lifestyle InterventionBehavioural
A 1 year lifestyle intervention based on the Diabetes Prevention Program to be delivered synchronously via weekly videoconference group meetings led by a professional weight loss counselor. In the subsequent year, a Peer-Led Maintenance Phase will occur in which a participant volunteer will lead the group after receiving a brief training.
| Study group | Role | What they receive |
|---|---|---|
| Asynchronous | Experimental | This arm involves a 1 year behavioral weight loss program delivered in private Facebook groups led by a professional weight loss counselor. At the end of 1 year, volunteer participants will take over the leadership role of the group for the following year. Volunteers will receive a brief training on how to lead a private Facebook group. Receives: Behavioral: Asynchronous Remote Lifestyle Intervention |
| Synchronous | Active comparator | This arm involves a 1 year behavioral weight loss program delivered via weekly videoconference meetings led by a professional weight loss counselor. At the end of 1 year, volunteer participants will take over the leadership role of the meetings for the following year. Volunteers will receive a brief training on how to lead videoconference meetings. Receives: Behavioral: Synchronous Remote Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of baseline weight loss at 6 months
Percent weight loss
Measured: 6 months
Percent of baseline weight loss at 12 months
Percent weight loss
Measured: 12 months
Secondary outcomes (8)
Word count of participant engagement in 1 year
word count
Measured: 1 year
Word count of participant engagement in 2 years
word count
Measured: 2 years
Collective Efficacy
Online Collective Efficacy Scale score out of a range of 0-210 where higher scores indicate greater collective efficacy
Measured: 1 year
Collective Efficacy
Online Collective Efficacy Scale score out of a range of 0-210 where higher scores indicate greater collective efficacy
Measured: 2 years
Cost in dollars per pound lost
Intervention cost will be computed for each participant and then divided by pounds lost
Measured: 1 year
Cost in dollars per pound lost
Intervention cost will be computed for each participant and then divided by pounds lost
Measured: 2 years
Percent of baseline weight lost at 18 months
Percent weight loss
Measured: 18 months
Percent of baseline weight lost at 24 months
Percent weight loss
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start6 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of two interventions.
- Masking
- None (open label)
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherry Pagoto, University of Connecticut
- Investigators
- Sherry Pagoto, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393725
- Sponsor's protocol ID
- H23-0383
- Status last verified
- Jun 2026
- First submitted
- 25 Apr 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data and associated documentation will be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Datasets will be stored with encryption and will be shared only after verification of human subjects institutional review board approval is obtained. By requesting human studies approval, we will be able to track recipients of the data, the type of data analyses proposed, and subsequent research findings. All storage and sharing of data will be in accordance with the policy and approval of University of Connecticut institutional review board.
Publications
Pagoto S, Xu R, Bannor R, Idiong C, Goetz J, Fernandes D. Comparing Synchronous and Asynchronous Remotely Delivered Lifestyle Interventions: Protocol for a Randomized Noninferiority Trial. JMIR Res Protoc. 2024 Dec 19;13:e65323. doi: 10.2196/65323.
PubMed 39700497
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Inferiority Trial Comparing Synchronous and Asynchronous Remotely Delivered Lifestyle Interventions
- ClinicalTrials.gov ID
- NCT06393725
- Acronym / sponsor ID
- H23-0383
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 1 May 2024 (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 goal of this clinical trial is to learn if a group-based digital weight loss program that is delivered asynchronously (via an online platform) is as effective as one that is delivered synchronously (via weekly videoconference meetings). In the asynchronous condition, participants can engage with their group any time 24/7. In the synchronous condition, participants can engage with their group once a week at a videoconference meeting. The main questions it aims to answer are:
Will participants in each condition lose about the same amount of weight? Will the participants in the asynchronous condition participate more than those in the synchronous condition? Will the participants in the asynchronous condition feel more connected to each other than those in the synchronous condition? Will the asynchronous condition cost less to deliver per pound lost than the synchronous condition?
Participants will:
Receive a digital weight loss program that lasts 1 year and then volunteer participants will be selected to lead the group for 1 year following the program, a phase called the "peer-led weight loss maintenance phase." Complete study assessments at baseline, 6, 12, 18, and 24 months.
Detailed description
Lifestyle interventions have had established efficacy for decades but they are costly and have poor scalability. Remotely-delivered lifestyle interventions have increased the potential for scale and systematic reviews have found that they are effective, especially those that include human coaching. Some remote lifestyle interventions are synchronous, such that they are delivered via videoconferencing or phone. Other remote lifestyle interventions are asynchronous, such that they are delivered via online platforms that allow for clinicians and patients to engage via text exchanges or via online groups where patients engage with a clinician and each other by posting messages and contributing to discussion threads. The advantage of asynchronous approaches are 24/7 accessibility which makes them conducive to "just in time" support, allowing patients to engage anytime they want to, as opposed to in scheduled blocks of time each week. Asynchronous, remote interventions may also be more scalable than synchronous remote interventions. A trial of two asynchronous, remote lifestyle interventions-one with a group of 94 participants and one with a group of 40 participants revealed similar weight loss and acceptability between conditions. The larger group was also more sustainable, such that participants continued to engage in the group for longer when the groups were turned over to participants to lead themselves for a year after the intervention ended-a period referred to as the peer-led maintenance phase. The next step in this research is to examine how an asynchronous, remote intervention compares to a synchronous, remote intervention, not only in short term weight loss, but also in sustainability, scalability, and weight loss maintenance. Now that the feasibility of conducing large asynchronous, remote groups has been established, the proposed trial will randomize participants to large groups (n=82) in both conditions, which will allow the comparison of synchronous to asynchronous remote interventions that are scaled up to a level established as acceptable for asynchronous remote interventions. The purpose of the proposed trial is to determine whether an asynchronous, remote lifestyle intervention is non-inferior to a synchronous, remote lifestyle intervention in weight loss at 6 and 12 months, but more scalable and sustainable, and thus producing greater weight loss maintenance at 18 and 24 months. Establishing evidence for asynchronous interventions is more important than ever given that telehealth reimbursement for behavioral health has recently expanded but is still limited to synchronous forms of remote care. Asynchronous interventions may be more convenient for some people and possibly more scalable but for this treatment model to reach its potential, evidence for efficacy is needed to inform reimbursement policy. The hypothesis is that an asynchronous, remote lifestyle intervention will produce similar initial weight loss as a synchronous, remote version but will be less expensive, more sustainable, and generate greater collective efficacy, which will drive greater weight loss maintenance at 18 and 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two interventions.
| Arm | Type | Receives |
|---|---|---|
| Asynchronous | Experimental | Behavioral: Asynchronous Remote Lifestyle InterventionThis arm involves a 1 year behavioral weight loss program delivered in private Facebook groups led by a professional weight loss counselor. At the end of 1 year, volunteer participants will take over the leadership role of the group for the following year. Volunteers will receive a brief training on how to lead a private Facebook group. |
| Synchronous | Active comparator | Behavioral: Synchronous Remote Lifestyle InterventionThis arm involves a 1 year behavioral weight loss program delivered via weekly videoconference meetings led by a professional weight loss counselor. At the end of 1 year, volunteer participants will take over the leadership role of the meetings for the following year. Volunteers will receive a brief training on how to lead videoconference meetings. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI 27-45
- has Bluetooth or wifi connectivity at home (for scale)
- goes on Facebook at least 5 days per week over the past 2 weeks
- has posted/replied at least once a week in the past 2 weeks (per self-report)
- has a smart phone
Key exclusion criteria (10 listed)
- Pregnant or lactating or plans to during study period
- bipolar disorder, substance abuse, psychosis, bulimia, binge eating disorder, or severe depression
- had bariatric surgery or plans to during the study
- currently taking meds affecting weight
- lost ≥5% of weight in 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 |
|---|---|---|
| Asynchronous Remote Lifestyle InterventionA 1 year lifestyle intervention based on the Diabetes Prevention Program to be delivered asynchronously via a private Facebook group led by a professional weight loss counselor. In the subsequent year, a Peer-Led Maintenance Phase will occur in which a participant volunteer will lead the group after receiving a brief training. | Behavioural | Asynchronous |
| Synchronous Remote Lifestyle InterventionA 1 year lifestyle intervention based on the Diabetes Prevention Program to be delivered synchronously via weekly videoconference group meetings led by a professional weight loss counselor. In the subsequent year, a Peer-Led Maintenance Phase will occur in which a participant volunteer will lead the group after receiving a brief training. | Behavioural | Synchronous |
Primary outcome
Percent of baseline weight loss at 6 months
Time frame: 6 months
Percent weight loss
Percent of baseline weight loss at 12 months
Time frame: 12 months
Percent weight loss
8 secondary outcomes
Word count of participant engagement in 1 year
Time frame: 1 year
Word count of participant engagement in 2 years
Time frame: 2 years
Collective Efficacy
Time frame: 1 year
Collective Efficacy
Time frame: 2 years
Cost in dollars per pound lost
Time frame: 1 year
Cost in dollars per pound lost
Time frame: 2 years
Percent of baseline weight lost at 18 months
Time frame: 18 months
Percent of baseline weight lost at 24 months
Time frame: 24 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 12 Jun 2026.
- Derived from this study: PubMed 39700497Pagoto S, Xu R, Bannor R, Idiong C, Goetz J, Fernandes D. Comparing Synchronous and Asynchronous Remotely Delivered Lifestyle Interventions: Protocol for a Randomized Noninferiority Trial. JMIR Res Protoc. 2024 Dec 19;13:e65323. doi: 10.2196/65323.
- Individual participant dataSharing planned: Yes. The data and associated documentation will be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Datasets will be stored with encryption and will be shared only after verification of human subjects institutional review board approval is obtained. By requesting human studies approval, we will be able to track recipients of the data, the type of data analyses proposed, and subsequent research findings. All storage and sharing of data will be in accordance with the policy and approval of University of Connecticut institutional review board.
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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.
Sherry Pagoto, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asynchronous Remote Lifestyle Intervention and Synchronous Remote Lifestyle Intervention in people with Obesity, run by University of Connecticut 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 5 inclusion and 10 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 12 Jun 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 of baseline weight loss at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT06393725, 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 12 Jun 2026.