Testing the Effectiveness of WW Clinic GLP1

Obesity Clinical Trial

— WW Clinic  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06034457
• Other study ID #: 23-814
• Status: Enrolling by invitation
• Start date: January 18, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood pressure changes (systolic and diastolic) in mmHg from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on blood pressure changes at 24 weeks	0 to 24 weeks
Other	Change in Quality of Life scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Quality of Life (QOL) scores	0 to 24 weeks
Other	Changes in Well-being scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Well-being at 24 weeks	0 to 24 weeks
Other	Changes in Physical Activity scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Physical Activity at 24 weeks	0 to 24 weeks
Other	Changes in Diet Quality scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Diet Quality at 24 weeks	0 to 24 weeks
Other	Changes in Hunger scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence)on Hunger scores at 24 weeks	0 to 24 weeks
Other	Changes in Stress scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Stress at 24 weeks	0 to 24 weeks
Other	Changes in Internalized Weight Bias scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Internalized Weight Bias	0 to 24 weeks
Other	Changes in Emotional Eating scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Emotional Eating scores	0 to 24 weeks
Other	Changes in Satisfaction scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Satisfaction scores	0 to 24 weeks
Other	Changes in Community scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Community scores	0 to 24 weeks
Other	Changes in Habit Strength scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Habit Strength scores	0 to 24 weeks
Other	Changes in Food Craving scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Food Craving scores	0 to 24 weeks
Other	Changes in Self-Compassion scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Self-Compassion scores	0 to 24 weeks
Other	Changes in Disordered Eating Behaviors scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Disordered Eating Behavior scores	0 to 24 weeks
Other	Changes in reported GLP1 Side Effects from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Side Effects scores	0 to 24 weeks
Other	Changes in Restraint/Disinhibition scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Ristraint/Disinhibition scores	0 to 24 weeks
Other	Changes in Body Appreciation scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Body Appreciation scores	0 to 24 weeks
Other	Changes in Depression symptom scores from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on Depression symptoms	0 to 24 weeks
Primary	Change in weight in pounds from week 0 to week 24	Effect of WW GLP1 behavioral program + WW Clinic (formerly known as Sequence) on weight loss at 24 weeks.	0 to 24 weeks
Secondary	Weight loss percentage change from week 0 to week 24	Effect of WW + WW Clinic (formerly known as Sequence) on weight loss at 12 weeks and % reaching 5, 10, 15, 20 % body weight loss at 24 weeks.	0 to 24 weeks