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Testing the Effectiveness of WW Clinic GLP1

NCT ID: NCT06034457

Last Updated: 2025-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-18

Study Completion Date

2024-10-17

Brief Summary

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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

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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

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Weight Loss Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. 18 years or older
2. BMI of \>30 or BMI of \>27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)
3. Access to a smartphone or tablet that runs iOS/iPadOS 15.0 or later, or Android 7.0 or later
4. A prescription for Wegovy, Mounjaro, or Zepbound

Exclusion Criteria

1. Diabetes
2. Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2
3. History of pancreatitis within 180 days
4. Previous surgical obesity treatment
5. Use of other anti-obesity medication in last 90 days
6. Use of GLP-1 within the last 180 days
7. Lost weight \>11 lbs in the last 90 days
8. Pregnant, breastfeeding, intends to become pregnant, of child-bearing potential and not using a highly effective contraceptive method
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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leslie heinberg

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amy DiVita

Role: STUDY_DIRECTOR

The Cleveland Clinic

Matthew Allman

Role: STUDY_DIRECTOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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). 2025 Nov 18. doi: 10.1002/oby.70056. Online ahead of print.

Reference Type DERIVED
PMID: 41253738 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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23-814

Identifier Type: -

Identifier Source: org_study_id