Testing the Effectiveness of WW Clinic GLP1

NeuroTherapia, Inc.

Status: Completed

Conditions: Weight Loss; Obesity

Study type: Observational

Funder types: Other

Identifiers

NCT06034457

23-814

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design