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Medications + WeightWatchers for Obesity (Meds WOW-WW Trial)
N/A
Recruiting
Led By Michelle Cardel, PhD, RD
Research Sponsored by Michelle Cardel, PhD, MS, RD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI of >30 or BMI of >27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)
Be older than 18 years old
Must not have
Currently taking naltrexone
Engagement with vomiting or laxative use within the last 28 days with the aim of controlling their shape or weight
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking at whether adults who are overweight or obese lose more weight by taking weight management medications alone or with behavioral and lifestyle support. They will measure the percentage of body weight lost after 12
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include those associated with the medications Bupropion/Naltrexone or Liraglutide such as nausea, headaches, dizziness. Behavioral support might also bring psychological stress due to lifestyle changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is over 30, or it's over 27 with a condition like high blood pressure or heart disease.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking naltrexone.
Select...
I have used vomiting or laxatives to control my weight in the last month.
Select...
I have a history of glaucoma.
Select...
I have a history of chronic kidney disease.
Select...
I am currently taking bupropion.
Select...
I have a history of seizures.
Select...
I have lost more than 11 pounds in the last 3 months.
Select...
I have had surgery for obesity.
Select...
I am not pregnant, breastfeeding, nor planning to become pregnant and I use effective birth control.
Select...
My blood pressure is not well-controlled.
Select...
I am currently using opioid medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent body weight lost at 12 weeks
Secondary study objectives
Body Appreciation
Change in body weight (in kg or pounds) at 12 weeks
Dietary Intake
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Meds plus WWExperimental Treatment1 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 aloneActive Control1 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).
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Who is running the clinical trial?
Michelle Cardel, PhD, MS, RDLead Sponsor
1 Previous Clinical Trials
225 Total Patients Enrolled
1 Trials studying Obesity
225 Patients Enrolled for Obesity
Michelle Cardel, PhD, RDPrincipal InvestigatorWW International Inc
3 Previous Clinical Trials
318 Total Patients Enrolled
2 Trials studying Obesity
234 Patients Enrolled for Obesity
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