Testing the Effectiveness of WW Clinic GLP1 (WW Clinic)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity; Weight Loss

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 Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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 + WW Clinic (formerly known as 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 + 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Study Director: Amy DiVita, The Cleveland Clinic; Study Director: Matthew Allman, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 23-814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No