NCT06470659
Completed
Not Applicable
Effectiveness of a Telehealth Medical Weight Management Program Prescribing Anti-obesity Medications Paired With a Digital Behavioral Weight Management Program
Michelle Cardel, PhD, MS, RD1 site in 1 country101 target enrollmentJune 17, 2024
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Michelle Cardel, PhD, MS, RD
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Percent body weight lost at 12 weeks
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Michelle Cardel, PhD, MS, RD
Senior Director of Global Clinical Research and Nutrition
WW International Inc
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Percent body weight lost at 12 weeks
Time Frame: Baseline, 12 weeks
Measurement of weight using a bluetooth body weight scale
Secondary Outcomes
- Physical Activity and Sedentary Behavior(Baseline, 12 weeks)
- Well-being(Baseline, 12 weeks)
- Impact on Quality of Life(Baseline, 12 weeks)
- Body Appreciation(Baseline, 12 weeks)
- Change in body weight (in kg or pounds) at 12 weeks(Baseline, 12 weeks)
- Habit/Automaticity(Baseline, 12 weeks)
- Self-Compassion(Baseline, 12 weeks)
- Dietary Intake(Baseline, 12 weeks)
- Hunger VAS (Visual Analogue Scale)(Baseline, 12 weeks)
- Food Cravings(Baseline, 12 weeks)
- Weight Bias(Baseline, 12 weeks)
Study Sites (1)
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