Medications With or Without WeightWatchers

NCT06470659 | Completed

• 1 other identifier: Meds WOW-WW
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• Percent body weight lost at 12 weeks

  Measurement of weight using a bluetooth body weight scale

  Baseline, 12 weeks

Secondary Outcomes (11)

• Change in body weight (in kg or pounds) at 12 weeks

  Baseline, 12 weeks

• Physical Activity and Sedentary Behavior

  Baseline, 12 weeks

• Dietary Intake

  Baseline, 12 weeks

• Habit/Automaticity

  Baseline, 12 weeks

• Hunger VAS (Visual Analogue Scale)

  Baseline, 12 weeks

Study Arms (2)

Meds alone

NO 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).

Meds plus WW

EXPERIMENTAL

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).

Behavioral: WW Clinic

Interventions

WW Clinic BEHAVIORAL

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

Meds plus WW

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michelle Cardel, PhD, MS, RD: lead

Study Sites (1)

WW International, Inc

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle Cardel, PhD, RD

  WW International Inc

  PRINCIPAL INVESTIGATOR

• Rebecca Jones, PhD

  WW International Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Director of Global Clinical Research and Nutrition

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 24, 2024
• Study Start: June 17, 2024
• Primary Completion: January 28, 2025
• Study Completion: January 28, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

US (1)