Weight LossWW ClinicNCT06034457
Testing the Effectiveness of WW Clinic GLP1
An observational study of Weight Loss and Obesity, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The study objective is to evaluate the efficacy of the WeightWatchers (WW) GLP-1 behavioral program + WW Clinic (formerly known as Sequence medical weight management program) on weight loss and related outcomes. Participants will be invited to take part and answer surveys at 0, 12 and 24 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss, Obesity
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2024to 17 Oct 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of patients who are already enrolled in WW Clinic (formerly known as Sequence) and prescribed GLP-1 medications.
Who may be able to join
- 18 years or older
- BMI of >30 or BMI of >27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)
- Access to a smartphone or tablet that runs iOS/iPadOS 15.0 or later, or Android 7.0 or later
- A prescription for Wegovy, Mounjaro, or Zepbound
Who cannot join
- Diabetes
- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2
- History of pancreatitis within 180 days
- Previous surgical obesity treatment
- Use of other anti-obesity medication in last 90 days
- Use of GLP-1 within the last 180 days
- Lost weight >11 lbs in the last 90 days
- Pregnant, breastfeeding, intends to become pregnant, of child-bearing potential and not using a highly effective contraceptive method
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 24 Week External Single-arm Study Testing the Effectiveness of WW GLP1 Behavioral Program + Sequence Medical Weight Management on Weight Loss and Related Outcomes
The study objective is to evaluate the efficacy of the WeightWatchers (WW) GLP-1 behavioral program + WW Clinic (formerly known as Sequence medical weight management program) on weight loss and related outcomes. Participants will be invited to take part and answer surveys at 0, 12 and 24 weeks.
Read the detailed description
This is a 24 week prospective single-arm efficacy outcomes study. Up to 180 adult participants who are currently enrolled in WW GLP-1 behavioral program program + WW Clinic (formerly known as Sequence medical weight management program) and already prescribed semaglutide or tirzepatide. The application of a comprehensive lifestyle-based intervention focused on dietary intake, physical activity, support and behavioral principles in conjunction with anti-obesity medication (AOM) is novel and may increase AOM efficacy while minimizing maintenance concerns. As obesity care can now be delivered virtually, it will also include an innovative strategy of virtual/remotely delivered medical care via Sequence and WW. Further, this study will examine multiple psychosocial domains associated with weight loss and weight loss related outcomes including physical activity, dietary behavior, disordered eating, depression symptoms, internalized weight bias and community, that have not been examined in AOM trials.
- Conditions
- Weight Loss, Obesity
- Medical subject headings
- Weight Loss, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight in Pounds From Week 0 to Week 24
Effect of WW GLP1 behavioral program + WW Clinic (formerly known as Sequence) on absolute change of weight loss at 24 weeks.
Measured: 0 to 24 weeks
Secondary outcomes (1)
Weight Loss Percentage Change From Week 0 to Week 24
Effect of WW + WW Clinic (formerly known as Sequence) on weight loss and % reaching 5, 10, 15, 20 % body weight loss at 24 weeks.
Measured: 0 to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start18 Jan 2024
- Primary completion17 Oct 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, leslie heinberg, The Cleveland Clinic
- Investigators
- Amy DiVita, Study director, The Cleveland ClinicMatthew Allman, Study director, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034457
- Sponsor's protocol ID
- 23-814
- Acronym
- WW Clinic
- Status last verified
- Dec 2025
- First submitted
- 24 Aug 2023
- Last updated
- 19 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heinberg LJ, Lee AM, Foster GD, DiVita A, Allman M, Rotroff D, Dargham CB, Cardel MI. Effectiveness of Telemedicine Prescribing and a Long-Acting Obesity Medication Behavioral Program: A 24-Week Single-Arm Study. Obesity (Silver Spring). 2026 Jun;34 Suppl 1:18-28. doi: 10.1002/oby.70056. Epub 2025 Nov 18.
PubMed 41253738
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24 Week External Single-arm Study Testing the Effectiveness of WW GLP1 Behavioral Program + Sequence Medical Weight Management on Weight Loss and Related Outcomes
- ClinicalTrials.gov ID
- NCT06034457
- Acronym / sponsor ID
- WW Clinic / 23-814
- Conditions
- Weight Loss, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Posted 19 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is to evaluate the efficacy of the WeightWatchers (WW) GLP-1 behavioral program + WW Clinic (formerly known as Sequence medical weight management program) on weight loss and related outcomes. Participants will be invited to take part and answer surveys at 0, 12 and 24 weeks.
Detailed description
This is a 24 week prospective single-arm efficacy outcomes study. Up to 180 adult participants who are currently enrolled in WW GLP-1 behavioral program program + WW Clinic (formerly known as Sequence medical weight management program) and already prescribed semaglutide or tirzepatide. The application of a comprehensive lifestyle-based intervention focused on dietary intake, physical activity, support and behavioral principles in conjunction with anti-obesity medication (AOM) is novel and may increase AOM efficacy while minimizing maintenance concerns. As obesity care can now be delivered virtually, it will also include an innovative strategy of virtual/remotely delivered medical care via Sequence and WW. Further, this study will examine multiple psychosocial domains associated with weight loss and weight loss related outcomes including physical activity, dietary behavior, disordered eating, depression symptoms, internalized weight bias and community, that have not been examined in AOM trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients who are already enrolled in WW Clinic (formerly known as Sequence) and prescribed GLP-1 medications.
Key inclusion criteria (4 listed)
- 18 years or older
- BMI of >30 or BMI of >27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)
- Access to a smartphone or tablet that runs iOS/iPadOS 15.0 or later, or Android 7.0 or later
- A prescription for Wegovy, Mounjaro, or Zepbound
Key exclusion criteria (8 listed)
- Diabetes
- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2
- History of pancreatitis within 180 days
- Previous surgical obesity treatment
- Use of other anti-obesity medication in last 90 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Weight in Pounds From Week 0 to Week 24
Time frame: 0 to 24 weeks
Effect of WW GLP1 behavioral program + WW Clinic (formerly known as Sequence) on absolute change of weight loss at 24 weeks.
1 secondary outcome
Weight Loss Percentage Change From Week 0 to Week 24
Time frame: 0 to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41253738Heinberg LJ, Lee AM, Foster GD, DiVita A, Allman M, Rotroff D, Dargham CB, Cardel MI. Effectiveness of Telemedicine Prescribing and a Long-Acting Obesity Medication Behavioral Program: A 24-Week Single-Arm Study. Obesity (Silver Spring). 2026 Jun;34 Suppl 1:18-28. doi: 10.1002/oby.70056. Epub 2025 Nov 18.
- Individual participant dataSharing planned: No
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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.
Amy DiVita study director
The Cleveland Clinic
Matthew Allman study director
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Loss and Obesity, run by The Cleveland Clinic 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 19 Dec 2025. 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?
Yes. Results are posted in the registry (first posted 19 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Weight in Pounds From Week 0 to Week 24 (time frame: 0 to 24 weeks). 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 NCT06034457, 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 19 Dec 2025.