Medications + WeightWatchers for Obesity

(Meds WOW-WW Trial)

Recruiting at 1 trial location

Overseen By Rebecca A Jones, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michelle Cardel, PhD, MS, RD

Must be taking: Bupropion/Naltrexone, Liraglutide

Must not be taking: Bupropion, Naltrexone, Opioids

Disqualifiers: Diabetes, Uncontrolled hypertension, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

101 Participants Needed

Trial Summary

What is the purpose of this trial?

The study compares the effectiveness of adults living with overweight or obesity taking weight management medications alone vs taking them with behavioral and lifestyle support. The primary outcome is percent body weight lost at 12-weeks.

Research Team

Michelle Cardel, PhD, RD

Principal Investigator

WW International Inc

Rebecca Jones, PhD

Principal Investigator

WW International Inc

Eligibility Criteria

This trial is for adults with obesity (BMI >30) or overweight (BMI >27) with related health issues like high blood pressure. They must be starting a weight management medication plan approved by WW Clinic, without recent significant weight loss, no history of eating disorders, surgical obesity treatment, seizures, glaucoma, or certain chronic diseases.

Inclusion Criteria

I am approved for and have started a plan with Bupropion/Naltrexone or Liraglutide.

My BMI is over 30, or it's over 27 with a condition like high blood pressure or heart disease.

Exclusion Criteria

I have had surgery for obesity.

I have used vomiting or laxatives to control my weight in the last month.

I have a history of glaucoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weight management medications with or without behavioral and lifestyle support

12 weeks

Regular virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• WeightWatchers

Trial Overview The study tests if taking weight management medications alone is as effective as combining them with behavioral and lifestyle support from WeightWatchers. The main goal is to see how much body weight participants lose after 12 weeks.

Participant Groups

Group I: Meds plus WW Experimental Treatment 1 Intervention

Participants in this group receive behavioral or lifestyle support from WW Clinic alongside their medications. The medications are not part of the intervention (it is part of the eligibility criteria).

Group II: Meds alone Active Control 1 Intervention

Participants in this group do not receive behavioral or lifestyle support alongside their medications. The medications are not part of the intervention (it is part of the eligibility criteria).

Who Is Running the Clinical Trial?

Michelle Cardel, PhD, MS, RD

Lead Sponsor

Trials

2

Recruited

330+