Clinical trial NCT06034457: Testing the Effectiveness of WW Clinic GLP1
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Loss
Obesity
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in weight in pounds from week 0 to week 24
timeFrame: 0 to 24 weeks
Secondary outcomes:
measure: Weight loss percentage change from week 0 to week 24
timeFrame: 0 to 24 weeks
Other outcomes:
measure: Blood pressure changes (systolic and diastolic) in mmHg from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Change in Quality of Life scores from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in Well-being scores from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in Physical Activity scores from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in Diet Quality scores from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in Hunger scores from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in Stress scores from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in Internalized Weight Bias scores from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in Emotional Eating scores from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in Satisfaction scores from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in Community scores from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in Habit Strength scores from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in Food Craving scores from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in Self-Compassion scores from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in Disordered Eating Behaviors scores from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in reported GLP1 Side Effects from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in Restraint/Disinhibition scores from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in Body Appreciation scores from week 0 to week 24
timeFrame: 0 to 24 weeks
measure: Changes in Depression symptom scores from week 0 to week 24
timeFrame: 0 to 24 weeks
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Amy DiVita
role: STUDY_DIRECTOR
affiliation: The Cleveland Clinic
name: Matthew Allman
role: STUDY_DIRECTOR
References: