Testing the Effectiveness of WW + Sequence GLP1 (WW+Sequence)

Study Overview
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Brief Summary
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The study objective is to evaluate the efficacy of the WeightWatchers (WW) GLP1 behavioral program + Sequence GLP1 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 GLP1 behavioral program program + 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 (Sequence for Medical Weight Management) 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.

Official Title
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24 Week External Single-arm Study Testing the Effectiveness of WW + Sequence GLP1 Medical Weight Management on Weight Loss and Related Outcomes

Conditions
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Weight Loss, Obesity

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 with iOS Exclusion criteria: 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 GLP1 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight in pounds from week 0 to week 24 | Effect of WW GLP1 behavioral program + Sequence on weight loss at 24 weeks. | 0 to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss percentage change from week 0 to week 24 | Effect of WW + Sequence on weight loss at 12 weeks and % reaching 5, 10, 15, 20 % body weight loss at 24 weeks. | 0 to 24 weeks |