Obesity, Overweight
Conditions
Brief summary
The study compares the effectiveness of treatment options for weight management after discontinuing semaglutide and tirzepatide. The primary outcome is absolute and percentage weight change at 12-weeks.
Interventions
BEHAVIORALWW Clinic
Telehealth platform that specializes in medical weight management and integrates the behavioral and lifestyle support from WW.
DRUGBupropion-Naltrexone
Bupropion-Naltrexone
DRUGBupropion-Naltrexone-Metformin
Bupropion-Naltrexone-Metformin
Sponsors
WW International Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Previous hx of BMI of \>30 or BMI of \>27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease) * Currently taking Wegovy, Ozempic, Mounjaro or Zepbound and have been for at least 6 months * At least 15% body weight loss since taking Wegovy, Ozempic, Mounjaro, or Zepbound * Willing to stop taking their GLP-1 medication or is discontinuing due to circumstances such as access, cost, coverage, choice, or any other reason * Ability to provide informed consent prior to any trial-related activities * Able to read and write in English
Exclusion criteria
* BMI \<22 kg/m2 * Diabetes * Previous surgical obesity treatment * Currently pregnant or intending to become pregnant during the study * Breastfeeding * History of seizures or epilepsy * Current opioid use or in acute opioid withdrawal * Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs * History of glaucoma * Uncontrolled hypertension * Severe renal impairment and/or Chronic kidney disease stage III or GFR \<60 * Acute hepatitis or liver failure * Acute or chronic metabolic acidosis, including diabetic ketoacidosis * Use of antipsychotic medications or opiod analgesics * 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 * Current SSRI, SNRI, mood stabilizer, amphetamine, or corticosteroid use * Current diagnosis of hyper or hypothyroidism or current use of thyroid replacement medicine * Current use of beta blockers * Current use of depo shot (medroxyprogesterone acetate) for birth control * Current diagnosis of Cushing's disease or syndrome * Current use of Monoamine Oxidase Inhibitors (MAOIs) * Known hypersensitivity to bupropion, naltrexone, or metformin * Any other reason rendering a participant unsuitable for trial participation, as determined by a clinician or study investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent body weight change at 12 weeks | Baseline, 12 weeks | Measurement of weight using a bluetooth body weight scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight (in kg or pounds) at 12 weeks | Baseline, 12 weeks | Measurement of weight using a bluetooth body weight scale |
| Physical Activity and Sedentary Behavior | Baseline, 12 weeks | The Global Physical Activity Questionnaire (GPAQ) is a 16 item scale. |
| Dietary Intake | Baseline, 12 weeks | 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. |
| Habit/Automaticity | Baseline, 12 weeks | The Self-Report Behavioral Automaticity Index (SRBAI) is a 4-item measure. |
| Hunger VAS (Visual Analogue Scale) | Baseline, 12 weeks | 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. |
| Impact on Quality of Life | Baseline, 12 weeks | 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 |
| Well-being | Baseline, 12 weeks | 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 |
| Body Appreciation | Baseline, 12 weeks | 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. |
| Self-Compassion | Baseline, 12 weeks | 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. |
| Weight Bias | Baseline, 12 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKara Marlatt, PhD, MPH
WW International Inc
Outcome results
None listed