Testing the Effectiveness of WW + Sequence GLP1 (WW+Sequence)
Study Details
Study Description
Brief Summary
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.
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Change in weight in pounds from week 0 to week 24 [0 to 24 weeks]
Effect of WW GLP1 behavioral program + Sequence on weight loss at 24 weeks.
Secondary Outcome Measures
- Weight loss percentage change from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on weight loss at 12 weeks and % reaching 5, 10, 15, 20 % body weight loss at 24 weeks.
Other Outcome Measures
- Blood pressure changes (systolic and diastolic) in mmHg from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on blood pressure changes at 24 weeks
- Change in Quality of Life scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Quality of Life (QOL) scores
- Changes in Well-being scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Well-being at 24 weeks
- Changes in Physical Activity scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Physical Activity at 24 weeks
- Changes in Diet Quality scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Diet Quality at 24 weeks
- Changes in Hunger scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Hunger scores at 24 weeks
- Changes in Stress scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Stress at 24 weeks
- Changes in Internalized Weight Bias scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Internalized Weight Bias
- Changes in Emotional Eating scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Emotional Eating scores
- Changes in Satisfaction scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Satisfaction scores
- Changes in Community scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Community scores
- Changes in Habit Strength scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Habit Strength scores
- Changes in Food Craving scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Food Craving scores
- Changes in Self-Compassion scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Self-Compassion scores
- Changes in Disordered Eating Behaviors scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Disordered Eating Behavior scores
- Changes in reported GLP1 Side Effects from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Side Effects scores
- Changes in Restraint/Disinhibition scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Ristraint/Disinhibition scores
- Changes in Body Appreciation scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Body Appreciation scores
- Changes in Depression symptom scores from week 0 to week 24 [0 to 24 weeks]
Effect of WW + Sequence on Depression symptoms
Eligibility Criteria
Criteria
Inclusion criteria:
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18 years or older
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BMI of >30 or BMI of >27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)
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Access to a smartphone with iOS
Exclusion criteria:
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Diabetes
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Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2
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History of pancreatitis within 180 days
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Previous surgical obesity treatment
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Use of other anti-obesity medication in last 90 days
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Use of GLP1 within the last 180 days
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Lost weight >11 lbs in the last 90 days
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Pregnant, breastfeeding, intends to become pregnant, of child-bearing potential and not using a highly effective contraceptive method
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- The Cleveland Clinic
Investigators
- Study Director: Amy DiVita, The Cleveland Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23-814