Medications With or Without WeightWatchers

NCT ID: NCT06470659

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-17

Study Completion Date

2025-01-28

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Meds alone

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Meds plus WW

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 Type EXPERIMENTAL

WW Clinic

Intervention Type BEHAVIORAL

Telehealth platform that specializes in medical weight management and integrates the behavioral and lifestyle support from WW

Interventions

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WW Clinic

Telehealth platform that specializes in medical weight management and integrates the behavioral and lifestyle support from WW

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* BMI of \>30 or BMI of \>27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)
* Determined eligible for Bupropion/Naltrexone or Liraglutide by WW Clinic medical provider and initiated a medication management plan

Exclusion Criteria

* Diabetes
* Uncontrolled hypertension
* History of seizures
* History of glaucoma
* History of chronic kidney disease
* Currently taking bupropion
* Currently taking naltrexone
* Current or previous history of anorexia or bulimia nervosa
* Engagement with vomiting or laxative use within the last 28 days with the aim of controlling their shape or weight
* Currently taking opioids
* Previous surgical obesity treatment
* Use of other anti-obesity medication in last 90 days or a GLP1 in the last 180 days
* Lost weight \>11 lbs in the last 90 days
* Pregnant, breastfeeding, intends to become pregnant, of child-bearing potential and not using a highly effective contraceptive method
* Any other reason rendering a participant unsuitable for trial participation, as determined by a clinician or study investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michelle Cardel, PhD, MS, RD

INDUSTRY

Sponsor Role lead

Responsible Party

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Michelle Cardel, PhD, MS, RD

Senior Director of Global Clinical Research and Nutrition

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michelle Cardel, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

WW International Inc

Rebecca Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

WW International Inc

Locations

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WW International, Inc

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Meds WOW-WW

Identifier Type: -

Identifier Source: org_study_id

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