Medications With or Without WeightWatchers (Meds WOW-WW)

Effectiveness of a Telehealth Medical Weight Management Program Prescribing Anti-obesity Medications Paired With a Digital Behavioral Weight Management Program

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: WW Clinic

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • NYC, New York, United States, 10010
      • WW International, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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).
Experimental: 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).	Behavioral: WW Clinic; Telehealth platform that specializes in medical weight management and integrates the behavioral and lifestyle support from WW

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent body weight lost at 12 weeks	Measurement of weight using a bluetooth body weight scale	Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight (in kg or pounds) at 12 weeks	Measurement of weight using a bluetooth body weight scale	Baseline, 12 weeks
Physical Activity and Sedentary Behavior	The Global Physical Activity Questionnaire (GPAQ) is a 16 item scale.	Baseline, 12 weeks
Dietary Intake	Diet ID is powered by Diet Quality Photo Navigation (DQPN®). It is a digital toolkit and 1 component will be used in the study: ID assessment.	Baseline, 12 weeks
Habit/Automaticity	The Self-Report Behavioral Automaticity Index (SRBAI) is a 4-item measure.	Baseline, 12 weeks
Hunger VAS (Visual Analogue Scale)	The Hunger VAS (Visual Analogue Scale) is a reliable measure for appetite research. The Hunger VAS asks "How hungry did you feel over the past week" and is composed of a line with words anchored at each end describing the extremes (Not at all hungry, Extremely hungry). Participants are asked to make a mark on the line corresponding to their feelings and quantification of the measurement is done by measuring the distance from the left end of the mark.	Baseline, 12 weeks
Impact on Quality of Life	The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) is a validated self-report measure for an individual's perception of how their weight affects their day-to-day life	Baseline, 12 weeks
Well-being	The World Health Organization (WHO-5) Well-being Index consists of five statements, which respondents rate, in relation to the past two weeks, using a six-point Likert scale	Baseline, 12 weeks
Body Appreciation	The Body Appreciation Scale (BAS-2) measures individuals acceptance of, favorable opinions toward, and respect for their bodies. There are 10 items, each assessed on a scale from 1-never to 5-always. Higher scores indicate higher body appreciation.	Baseline, 12 weeks
Food Cravings	The Food Cravings Inventory (FCI-II) is a 33-item self-report measure designed to assess the subjective experience of food craving across 33 different foods	Baseline, 12 weeks
Self-Compassion	The Self-Compassion Scale (SCS) is a 26-item measure of self-compassion that is psychometrically valid and theoretically coherent. The SCS consists of six subscales: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identified. Subscales are computed by calculating the mean of subscale item responses. A total self-compassion score can be obtained by reverse scoring the negative subscale items (self-judgment, isolation, and over-identification) and computing a grand mean of all six subscale means. Higher scores indicate greater self compassion.	Baseline, 12 weeks
Weight Bias	The Weight Bias Internalization Scale (WBIS-2F) has 13 items and responses are rated on a 7-point Likert scale(strongly disagree -strongly agree). Responses provide insight on the participant's internalized beliefs and feelings regarding their weight. There are two subscales: Weight-Related Distress (7 items; 7-13; Cronbach's alpha =0.910) and Weight-Related Self-Devaluation (6 items; 1-6; Cronbach's alpha =0.763). The WBIS-2F has been tested for validity in people with overweight and obesity and the two factor model demonstrated good to excellent fit with the data. Scores are calculated by taking an average of the response values. Questions 1,2,4,5, should be reverse scored before calculating the average. Higher scores indicating greater internalized weight bias.	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Michelle Cardel, PhD, MS, RD
• Investigators: Principal Investigator: Michelle Cardel, PhD, RD, WW International Inc; Principal Investigator: Rebecca Jones, PhD, WW International Inc

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Actual): January 28, 2025
• Study Completion (Actual): January 28, 2025

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: Meds WOW-WW

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No