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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
226
Telehealth platform that specializes in medical weight management and integrates the behavioral and lifestyle support from WW.
Bupropion-Naltrexone
Bupropion-Naltrexone-Metformin
WW International, Inc
New York, New York, United States
Percent body weight change at 12 weeks
Measurement of weight using a bluetooth body weight scale
Time frame: Baseline, 12 weeks
Change in body weight (in kg or pounds) at 12 weeks
Measurement of weight using a bluetooth body weight scale
Time frame: Baseline, 12 weeks
Physical Activity and Sedentary Behavior
The Global Physical Activity Questionnaire (GPAQ) is a 16 item scale.
Time frame: 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.
Time frame: Baseline, 12 weeks
Habit/Automaticity
The Self-Report Behavioral Automaticity Index (SRBAI) is a 4-item measure.
Time frame: 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.
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 weeks